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Although evidence suggests that asthma onset occurs early in childhood, many standard asthma outcome measures are either impractical or unreliable in preschool-aged children. In this population, for instance, patient history and symptom reports rely on the observations of caregivers, who tend to underreport their child's asthma symptoms. Furthermore, the use of conventional measures of pulmonary function such as spirometry may be impractical in very young children. Recent clinical studies have used a variety of techniques to measure symptoms, pulmonary function, and cellular mediators of inflammation. Outcomes such as discontinuation and exacerbation rates, frequency of daytime and nocturnal symptoms, and caregiver assessments of quality of life can be useful measures in evaluating outcomes in young children with asthma. Some measures, such as plethysmography and inflammatory marker analysis, may be suitable options for assessing pulmonary function and predicting asthma susceptibility in preschool-aged children. Indeed, altered levels of inflammatory markers, including immunoglobulin E, interleukin-10, and exhaled nitric oxide, may be useful tools in diagnosing asthma, evaluating interventions, and assessing future risks for asthma symptomatology in very young children. Whether 1 or more of these outcome measures will prove useful clinically in improving the diagnosis and management of childhood asthma remains uncertain, although early research results are encouraging. [ABSTRACT FROM AUTHOR]

In the treatment of childhood asthma, balancing safety and efficacy is key to achieving optimal therapeutic benefit. Inhaled corticosteroids (ICS), because of their efficacy, remain a cornerstone in managing persistent pediatric asthma, but also are associated with significant adverse effects, including growth suppression. Consequently, careful attention must be given to balancing their safety and efficacy, which should include an understanding of airway patency and systemic absorption (dose, disease severity, propellant and lipophilicity of inhalant), bioavailability (inhalation technique, propellant, delivery devices, and hepatic first-pass metabolism), techniques for using minimum effective doses (dosing time, add-on therapy), and reduction of other exacerbating conditions (allergens, influenza, upper-respiratory diseases). The growth-suppressive effects of ICS may be most evident in children with: 1) mild asthma because the relatively high airway patency may facilitate increased levels of deposition and steroid absorption in more distal airways, and 2) evening dosing that may reduce nocturnal growth hormone activity. A step-down approach targeting a minimum effective dose and once-daily morning dosing is suggested for achieving the most acceptable safety/efficacy balance with ICS. The achievement of regular, safe, and correct ICS use requires significant knowledge and time for both caregiver and patient. Chromones, methylxanthines, long-acting beta-agonists, and leukotriene receptor antagonists are currently available alternatives to ICS for the control of persistent childhood asthma. Chromones are safe but, like methylxanthines, are difficult to use and frequently result in compromised effectiveness. Long-acting beta-agonists are not recommended as monotherapy for persistent asthma. Several factors that support leukotriene receptor antagonists as a therapeutic option for mild-to-moderate persistent pediatric asthma include established efficacy, good safety profiles, and simple, oral dosing. Physicians must evaluate and compare the balance of safety and efficacy for each agent to determine the appropriate asthma therapy for individual patients. [ABSTRACT FROM AUTHOR]

Objective: To examine the hypothesis that diverse ties to friends, family, work, and community are associated with increased host resistance to infection.Design: After reporting the extent of participation in 12 types of social ties (eg, spouse, parent, friend, workmate, member of social group), subjects were given nasal drops containing 1 of 2 rhinoviruses and monitored for the development of a common cold.Setting: Quarantine.Participants: A total of 276 healthy volunteers, aged 18 to 55 years, neither seropositive for human immunodeficiency virus nor pregnant.Outcome Measures: Colds (illness in the presence of a verified infection), mucus production, mucociliary clearance function, and amount of viral replication.Results: In response to both viruses, those with more types of social ties were less susceptible to common colds, produced less mucus, were more effective in ciliary clearance of their nasal passages, and shed less virus. These relationships were unaltered by statistical controls for prechallenge virus-specific antibody, virus type, age, sex, season, body mass index, education, and race. Susceptibility to colds decreased in a dose-response manner with increased diversity of the social network. There was an adjusted relative risk of 4.2 comparing persons with fewest (1 to 3) to those with most (6 or more) types of social ties. Although smoking, poor sleep quality, alcohol abstinence, low dietary intake of vitamin C, elevated catecholamine levels, and being introverted were all associated with greater susceptibility to colds, they could only partially account for the relation between social network diversity and incidence of colds.Conclusions: More diverse social networks were associated with greater resistance to upper respiratory illness. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To assess the effects of the new inhaled corticosteroid ciclesonide on growth in children with asthma. METHODS: We performed a multicenter, randomized, double-blind, placebo-controlled study to assess the effects of inhaled ciclesonide on growth in children with mild, persistent asthma. After a 6-month run-in period, 661 prepubertal children who were aged 5.0 to 8.5 years were randomly assigned to once-daily morning treatment for 1 year with ciclesonide 40 or 160 microg (ex-actuator) or placebo, followed by a 2-month follow-up period. The primary end point was the linear growth velocity (linear regression estimate) over the double-blind treatment period. Growth was recorded as the median of 4 stadiometer measurements. Adverse events and 10-hour overnight and 24-hour urinary free cortisol levels were also assessed. RESULTS: Mean linear growth velocity during run-in was comparable between groups: 160 microg, 6.20 cm/year; 40 microg, 6.59 cm/year; placebo, 6.49 cm/year. Mean differences from placebo (5.75 cm/year) in growth velocity over the double-blind treatment period were -0.02 cm/year for ciclesonide 40 microg and -0.15 cm/year for ciclesonide 160 microg. Both ciclesonide treatments were noninferior to placebo with respect to growth velocity. The overall incidence of adverse events was comparable between groups, and no significant changes in 10-hour overnight or 24-hour urinary free cortisol levels were noted between groups during the double-blind treatment period. CONCLUSIONS: Ciclesonide demonstrated no detectable effect on childhood growth velocity, even at the highest dosage, which may ease concerns about systemic adverse events. [ABSTRACT FROM AUTHOR]

Background: The therapeutic margin of a drug is the difference between the optimal effective dose and the dose at which unacceptable adverse effects occur. This margin is particularly important in the case of therapies that are used long term for the control of chronic illnesses, such as inhaled corticosteroids (ICSs) in the treatment of asthma. Because data from controlled clinical studies indicate that the available ICSs have similar clinical efficacy, the safety profile is central to differentiating between them on the basis of their therapeutic margins. The main safety concern with long-term use and high doses of ICSs is systemic exposure that could result in such unwanted effects as cortisol suppression, a reduction in the final adult height of pediatric patients, and decreased bone mineral density.Objective: This article reviews data from clinical trials, including long-term prospective studies, to compare the therapeutic margin of budesonide with those of other second-generation ICSs and to determine whether there are variations in the therapeutic margin with different delivery devices, severities of disease, or patient age.Results: Based on the tolerability data for budesonide from short-term (6-12 wk) and long-term (1-9 y) studies in patients with mild to moderate persistent asthma, the dose-response and dose-tolerability curves for budesonide delivered by dry-powder inhaler can be plotted in parallel. The margin between these curves--the therapeutic margin--is favorable and consistent in pediatric and adult patients and at all degrees of asthma severity. Fewer tolerability data are available for other ICSS.Conclusion: Whereas budesonide has clinical efficacy similar to that of other currently available ICSs, it has a good safety profile--and hence a favorable therapeutic margin--that is supported by long-term clinical data. Budesonides favorable therapeutic margin is probably a result of its pharmacokinetic and physical properties. [ABSTRACT FROM AUTHOR]

All drugs have potential side effects, but thoughtful use can maximize benefits while minimizing risks. Children should not be considered just small adults regarding drug safety because their growth and development are discordant with their ability to sense and self-report drug side effects. Detecting side effects requires vigilance and education from prescribers to parents, who are tasked with monitoring their child over time. A drug's safety profile is published in the package label after pivotal trials are conducted in relatively small and sometimes narrow segments of the population during the U.S. Food and Drug Administration approval process. Drug safety profiles can change as data from postmarketing reports and long-term monitoring during phase IV trials emerge. As such, prescribers are obligated to maintain current understanding of any changes to drug labels. Discussing potential side effects, monitoring, and when to report concerns can be a time-consuming process during patient encounters. This review offers current information regarding potential side effects of some of the most commonly used medications for allergic conditions, asthma, and atopic dermatitis. This information and discussion will hopefully assist clinicians in their conversations with parents, including advice surrounding prescribing medication to minimize adverse effects, parental monitoring, and documentation., (Copyright © 2022 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Background: Intranasal corticosteroids (INCS) are the cornerstone of treatment for chronic rhinosinusitis. Although INCS are generally considered safe and effective, there is a concern that chronic use may lead to ocular adverse effects. Objective: To assess ocular safety of the exhalation delivery system with fluticasone propionate (EDS-FLU) in patients with chronic rhinosinusitis with nasal polyps. Methods: Ocular safety data were collected during two randomized, double-blind, placebo controlled studies with open-label extensions. Ophthalmologists performed tonometry, slit-lamp, and visual acuity examinations to assess intraocular pressure (IOP) and the presence of cataracts. Ocular examinations were conducted before double-blind treatment, at the end of the 16-week double-blind phase, and at the end of the 8-week open-label phase. The results of pooled data from patients who received EDS-FLU 186 µg (n = 160), EDS-FLU 372 µg (n = 161), and EDS-placebo (n = 161) twice daily are reported here. Results: At the end of the double-blind phase, six patients developed elevated average IOP > 21 mm Hg: two patients (1.2%) in the EDS-placebo group, three patients (1.9%) in the EDS-FLU 186 µg group, and one patient (0.6%) in the EDS-FLU 372 µg group. In addition, 6 of 482 patients developed cataracts: 3 patients in the EDS-placebo group, 2 patients in the EDS-FLU 186 µg group, and 1 patient in the EDS-FLU 372 µg group. At the end of the open-label phase, two additional patients showed IOP > 21 mm Hg and two additional patients developed cataracts. Conclusion: No increased risk of elevated IOP was detected with EDS-FLU; the rate of cataract development was similar to EDS-placebo and to that reported with other INCS.Clinical trials NCT01622569 and NCT01624662, www.clinicaltrials.gov.

Introduction: Outdoor air pollution (OAP) contributes to poor asthma outcomes and remains a public health concern in Pittsburgh. The purpose of this study was to determine the prevalence of childhood asthma and its rate of control among Pittsburgh schoolchildren residing near OAP sites., Methods: Participants were recruited from schools near OAP sites. Asthma prevalence and control were assessed using a validated survey. Demographics and socioeconomic status were collected by survey, BMI was calculated, secondhand smoke (SHS) exposure was assessed by salivary cotinine levels, and OAP was assessed by mobile platform monitoring. Multivariate analysis adjusted for confounders., Results: In 1202 Pittsburgh elementary school students surveyed, 50.9% were female, average age was 8.5 years (SD = 1.9), 52.2% were African American and 60.6% had public health insurance. SHS exposure was relatively high at 33.9%, 17.1% of students were obese, and 70% had exposure to particulate matter (PM 2.5 ) greater than the World Health Organization standard of 10 μg/m 3 . Overall prevalence of asthma was 22.5% with PM 2.5 , nitric oxide (NO x ), sulfur (S), and zinc (Zn) significantly related to odds of asthma. Among the 270 children previously diagnosed with asthma, 59.3% were not well controlled with PM 2.5 , black carbon, and silicon (Si) significantly related to odds of uncontrolled asthma., Conclusions: These results demonstrate that asthma prevalence and poor disease control are significantly elevated in Pittsburgh schoolchildren exposed to high levels of OAP. Future efforts need to focus on primary prevention of asthma by reducing exposure to OAP in at risk populations.

Background: Limited comparative data are available on the impact of systemic corticosteroid (SCS) use in children and adolescents., Objective: To determine if asthmatic children and adolescents treated with SCS have a higher likelihood of developing complications versus those not receiving SCS and to examine health care resource utilization (HCRU) in this population., Methods: A retrospective study of data from children and adolescents with persistent asthma retrieved from the MarketScan database, a large US health claims data set, for the period 2000 to 2017 was performed. Propensity score matching was used to pair patients in the SCS and control cohorts. For complications, SCS subgroups (≥4 or 1-3 annual prescriptions) were compared with asthmatic controls without SCS using logistic regression, and for HCRU, cohorts were compared using negative binomial regression., Results: A total of 67,081 patients were included (SCS: 23,898; control: 43,183). The odds of having a complication were 2.9 (95% confidence interval [CI], 2.5-3.2; P < .001) and 1.6 (95% CI, 1.6-1.7; P < .001) times higher in the ≥4 and 1 to 3 SCS groups, respectively, in the first year of follow-up versus controls. For asthma-related hospitalizations, the incidence rate ratio (IRR) was 6.9 (95% CI, 5.6-8.6) and 3.1 (95% CI, 2.8-3.4) times greater in the ≥4 SCS and 1 to 3 SCS groups, respectively, versus controls; for asthma-related emergency department visits, IRR was 5.0 (95% CI, 4.4-5.6) and 2.9 (95% CI, 2.7-3.0) times greater, respectively, versus controls (all P < .01)., Conclusion: Children and adolescents receiving SCS for persistent asthma have an increased risk of developing complications and have greater HCRU in the first year of follow-up versus those without SCS exposure., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: An Asthma Adherence Pathway (AAP) application, which is an Internet application that combines patient and clinician education strategies to promote adherence to asthma therapy, has been developed., Objective: The primary objective of this pilot study was to evaluate the effectiveness of the AAP application with electronic adherence monitors on asthma control. Secondary objectives evaluated the effect of AAP and monitors on medication adherence, asthma symptoms, quality of life, psychosocial factors, and barriers to treatment., Methods: Adult patients with asthma were randomly assigned either to intervention (n = 19) or control (n = 20) groups in this 3-month prospective study, and they completed the Asthma Control Questionnaire (ACQ). Intervention patients completed the AAP software and were given barrier-specific motivational interviewing adherence strategies and a SmartTrack device to monitor mometasone furoate/formoterol (MF/F) use. Clinicians in the interventional group received adherence management training. Interventional patients were given feedback regarding adherence findings at each visit. Treatment adherence was determined by the mean of 4 measures of doses taken over 3 months. Control patients were not monitored for MF/F adherence., Results: The mean MF/F adherence in the intervention group was 81%. The intervention and control groups did not differ on the mean baseline ACQ. Thirteen intervention patients achieved the minimal important difference (defined as an improvement ≥0.5 units on the ACQ) compared with 6 control patients (P = .016). The intervention group showed greater improvement in the ACQ (0.75) than the control group (0.19) representing a moderate-to-large effect size of d = 0.638., Conclusions: The AAP was effective in promoting adherence and helped to improve asthma control. These findings provide preliminary validation of the AAP model., (Copyright © 2019 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Background: Adults and adolescents were included in 3 phase 3 omalizumab trials in chronic idiopathic urticaria (CIU): ASTERIA I, ASTERIA II, and GLACIAL., Objective: To describe the baseline clinical profile of adolescent patients with CIU enrolled in the omalizumab trials to add to the limited literature available on CIU in this population., Methods: Data for patient demographics, baseline clinical disease characteristics, medical history, and previous CIU medication information (not efficacy assessments) from phase 3 omalizumab trials were pooled and descriptive statistical analyses performed for adolescent (12 to <18 years old) and adult (≥18 years old) subgroups. Inferential analysis was inappropriate, partly because of small sample size in the adolescent subgroup., Results: The pooled population of 975 patients with CIU included 39 adolescents (4.0%). Demographics of adolescents and adults with CIU were similar, but compared with adults, fewer adolescents had positive Chronic Urticaria Index test results. Baseline clinical disease characteristics were also similar between the subgroups, with the number of previous CIU medications slightly lower in adolescents compared with adults. Medical history and existing conditions in adolescents tended to be more allergy than cardiovascular related, and fewer experienced angioedema compared with adults., Conclusion: Pooled data indicate differences in baseline demographic and clinical characteristics between adult and adolescent patient subgroups. This finding helps augment our understanding of the clinical profile of CIU in adolescents, but larger-scale studies in this population are warranted., Trial Registration: ClinicalTrials.gov Identifiers: NCT01287117 (ASTERIA I), NCT01292473 (ASTERIA II), and NCT01264939 (GLACIAL)., (Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Both slowed growth in children and reduced bone mineral density (BMD) are systemic effects of corticosteroids, and there is concern about the degree to which these systemic effects affect growth and BMD., Objective: To engage in a data-driven discussion of the effects of inhaled corticosteroids (ICSs) on growth in children and BMD., Methods: Articles were selected based on their relevance to this review., Results: Studies of ICSs in children in which growth was a secondary outcome have revealed slowed growth associated with low doses of budesonide, fluticasone propionate, and beclomethasone dipropionate. In the study of budesonide, the effect was permanent, and in the study of fluticasone propionate, the effect was long-lasting, but it is unclear whether the effect was permanent. However, the results of studies in which growth was the primary outcome were mixed. Slowed growth was detected in a study of beclomethasone dipropionate; however, slowed growth was not detected in a study of ciclesonide or flunisolide. A decrease in BMD acquisition in children was associated with high doses but not low to medium doses of ICSs. In adults, there was a dose-related effect of ICSs on BMD. Both higher daily dose and larger cumulative dose were associated with increased bone density loss., Conclusion: Because of the systemic effects on growth and bone health, children should be monitored for growth using stadiometry every 3 to 6 months and BMD should be monitored yearly in patients being treated with high doses of ICSs., (Copyright © 2016 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Background: Earlier 1-year growth studies that used older inhaled corticosteroid (ICS) formulations consistently showed that ICS, but not intranasal corticosteroids (INCS), produced a small ∼1 cm/y growth effect that appeared to be nonprogressive and noncumulative. Studies that lasted for >1 year showed that such treatment during childhood did not affect final adult height. Collectively, these studies led to the beliefs that (1) the small short-term effect on growth is unimportant, (2) there is no long-term harm, and (3) any small risk is easily outweighed by the benefit. This led to the cavalier use of ICS and INCS in children and approval of some INCS for over-the-counter sales for children as young as 2 years of age., Methods: Literature search using Pub-Med., Results: More recent studies, with improved scientific designs, have challenged and overturned the earlier beliefs. Moreover, some of the newer ICS formulations have negative, robust growth studies (designed per FDA guidance and detected no growth effect)., Conclusions: This review focused on the new evidence and how it will change the way that we use ICS and INCS in children with allergy and asthma in both clinical practice and research, with a renewed focus on safety. There also are significant implications for future iterations of asthma guidelines. The goal was to identify the proper amount of new concern about ICS and INCS, not to generate undue steroid "phobia."

Sublingual immunotherapy (SLIT) is a safe and effective treatment for allergic rhinitis (AR) and allergic rhinoconjunctivitis (ARC). The Food and Drug Administration (FDA) in the USA has approved three SLIT tablets for the treatment of AR and ARC in relation to pollen. Specifically, Grastek® and Oralair® are two formulations approved to treat patients suffering with AR/ARC to grass pollen, and Ragwitek™ is a formulation approved to treat patients suffering with AR/ARC to ragweed pollen. Although these approvals provide support for physicians to prescribe SLIT, barriers to prescribing SLIT still remain such as FDA approval for additional formulations, a standard dose and dosing schedule, and cost/insurance coverage. In order to further support the use of SLIT, research is currently being conducted to expand the indication for SLIT to other common comorbidities to AR/ARC. For example, allergic asthma, food allergies, and atopic dermatitis are other diseases which are being explored. The future of SLIT in the USA is unknown; however, education will be necessary for both providers and patients.

Background: Inadequate designs and conflicting results from previous studies prompted the US Food and Drug Administration to publish guidelines for the design of clinical trials evaluating the effects of orally inhaled and intranasal corticosteroids on the growth of children. This study conformed to these guidelines to evaluate the effect of triamcinolone acetonide aqueous nasal spray (TAA-AQ) on the growth of children with perennial allergic rhinitis (PAR)., Methods: This randomized, double-blind, placebo-controlled, parallel-group, multicenter study evaluated the effect of once-daily TAA-AQ (110 μg) on the growth velocity (GV) of children aged 3-9 years with PAR by using stadiometry at baseline (4-6 months), during treatment (12 months), and at follow-up (2 months). Hypothalamus-pituitary-adrenal (HPA) axis function was assessed by measuring urinary cortisol levels. Details of adverse events were recorded., Results: Of 1078 subjects screened, 299 were randomized, and 216 completed the study (placebo, 107; TAA-AQ, 109). In the primary analysis (modified intent-to-treat: placebo, 133; TAA-AQ, 134), least-squares mean GV during treatment was lower in the TAA-AQ group (5.65 cm/year) versus placebo (6.09 cm/year). The difference (-0.45 cm/year; 95% confidence interval: -0.78 to -0.11; P = .01), although clinically nonsignificant, was evident within 2 months of treatment and stabilized thereafter. At follow-up, the GV approached baseline (6.70 cm/year) in the TAA-AQ group (6.59 cm/year) and decreased slightly in the placebo group (5.89 cm/year vs 6.06 cm/year at baseline). No HPA axis suppression was observed., Conclusions: By using rigorous Food and Drug Administration-recommended design elements, this study detected a small, statistically significant effect of TAA-AQ on the GV of children with PAR., (Copyright © 2015 by the American Academy of Pediatrics.)

Background: Chronic rhinosinusitis (CRS) and asthma frequently coexist in children and adults. However, the precise pathophysiologic mechanism of this interaction is still poorly understood, especially in children, owing to the lack of direct measurements of mucosal inflammation in the upper airways., Objective: To determine the pathophysiologic mechanism by analyzing the expression of a large array of inflammatory cytokines and chemokines in the sinus and adenoid tissues surgically removed from pediatric patients with CRS refractory to medical management., Methods: Twenty-eight children 2 to 12 years old diagnosed with CRS with or without asthma and 10 controls were included in this prospective, nonrandomized study. Mucosal expression of 40 inflammatory cytokines was measured with a multiplex assay and was normalized to total tissue protein., Results: Compared with children with CRS and without asthma, children with CRS and asthma had significantly higher sinus levels of tumor necrosis factor-α and adenoid levels of epidermal growth factor, eotaxin, fibroblast growth factor-2, growth-related oncogene, and platelet-derived growth factor-AA., Conclusion: The inflammatory response in the upper airway mucosa of children with asthma and CRS was similar, but more severe, compared with children with CRS without asthma. This observation is consistent with the hypothesis that asthma in these patients is caused or exacerbated by severe upper airway disease and supports the concept that treating sinus disease is paramount in the management of chronic asthma in children using, for the first time, direct measurements of airway inflammation in children., (Copyright © 2015 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Objective: To evaluate the effectiveness of asthma education delivered by student pharmacists and to assess the impact of child and caregiver baseline asthma knowledge on asthma control in children., Design: Student pharmacists developed and implemented asthma self-management education interventions for children and their caregivers and performed asthma screenings for children at a series of asthma camps., Assessment: Eighty-seven children, ages 5-17 years, and their caregivers were enrolled in this study. A previously validated asthma questionnaire was modified to assess asthma knowledge among children and adults. Asthma knowledge increased significantly in children following participation in the education intervention (p<0.001). The education intervention, however, did not increase caregiver knowledge of asthma. A significant association was observed between caregiver baseline asthma knowledge and better asthma control in their children (p=0.019)., Conclusion: The results of this study demonstrate that student pharmacist-delivered asthma education can positively impact asthma knowledge in children, and that caregivers' knowledge of asthma is strongly correlated with better asthma control in their children.

Purpose of Review: Sublingual immunotherapy (SLIT) is indicated for the use in pediatric patients suffering from allergic rhinitis or allergic rhinoconjunctivitis caused by environmental allergens, such as ragweed pollen, grass pollen, and dust mite. This review focuses on recent and relevant studies associated with the use of SLIT for these allergens in children by examining efficacy, safety, and immunological data in comparison to subcutaneous immunotherapy, therapeutic treatments, and placebo., Recent Findings: In several of the case studies examined in this article, involving mainly grass and dust mite allergic patients, SLIT has been shown to have similar efficacy to subcutaneous immunotherapy. SLIT has been proven as a safer therapy. In comparing the adverse events related to both therapies, SLIT has fewer cases of anaphylaxis and fewer incidents of local reactions of mild-to-moderate severity. In comparison to therapeutic treatments and placebo, SLIT significantly improved symptom and medication scores. In addition to allergic rhinitis and allergic rhinoconjunctivitis, additional uses for SLIT in pediatric patients, such as asthma, atopic dermatitis, and food allergies, are under development., Summary: SLIT treatment is a well tolerated and effective approach to treat allergic rhinitis and allergic rhinoconjunctivitis in pediatric patients. Three SLIT tablets are currently approved by the US Food and Drug Administration to treat grass and ragweed allergies. The research discussed in this review will further the knowledge of physicians searching for an alternative treatment for their pediatric patients.

Background: The practices and beliefs of the provider specialties that treat allergic rhinoconjunctivitis (ARC) with allergen immunotherapy (AIT) may vary., Methods: A telephone survey of 500 randomly selected health care practitioners in 7 specialties, conducted in 2012., Results: AIT was provided as a subcutaneous injection (SCIT) by 91% of allergist/immunologists, 54% of otolaryngologists, and 18% to 24% of other specialties. Otolaryngologists were the most frequent providers of sublingual drops of AIT (SLIT; 33%), compared to 2% to 10% of other specialties. AIT was recommended for adults with allergic rhinoconjunctivitis by 100% of allergist/immunologists vs 62% to 84% of the other specialties (p < 0.001). The primary reason for recommending AIT for adults (52%) or children (46%) was that other therapies did not work. Between 48% (nurse practitioners/physician assistants) and 93% (allergist/immunologists) of practitioners always or often decreased symptomatic medications over the course of AIT treatment. Most practitioners in all specialties (82-100%) thought that AIT was appropriate for patients with severe allergy symptoms. Significantly more allergist/immunologists and otolaryngologists than other specialists thought AIT was appropriate for mild allergy symptoms (p < 0.001 and p = 0.004, respectively, vs other specialties). Significantly more allergist/immunologists than other specialists thought that AIT was more effective than symptomatic medications (p < 0.001), could reduce the further development of allergies (p = 0.03), and could prevent the development of asthma., Conclusion: SCIT was more frequently provided than SLIT by all the specialties. Otolaryngologists were the most likely to offer SLIT, while very few allergist/immunologists offered SLIT. Allergist/immunologists differed from other specialties in some beliefs about the effectiveness of AIT., (© 2014 ARS-AAOA, LLC.)

The effect of cetirizine on quality of life (QOL) in subjects with perennial allergic rhinitis (PAR) has been previously evaluated using generic instruments. While generic QOL tools are used across various conditions, disease-specific instruments evaluate the impact of treatment on areas that are affected by that particular condition. This study evaluated the effect of cetirizine on symptom severity and health-related QOL, using a disease-specific instrument, in adults with PAR. This randomized, double-blind, placebo-controlled study was conducted at 15 U.S. centers outside the pollen allergy season. After a 1-week placebo run-in period, qualified subjects aged 18-65 years with PAR were randomized to once-daily cetirizine 10 mg (n = 158) or placebo (n = 163) for 4 weeks. Change from baseline in total symptom severity complex (TSSC) and overall Rhinitis Quality of Life Questionnaire (RQLQ) scores were primary efficacy end points. Cetirizine produced significantly greater improvements in mean TSSC for each treatment week (p < 0.05) and for the entire 4-week treatment period (p = 0.005) compared with placebo. After 4 weeks, cetirizine-treated subjects reported significantly greater overall improvement in RQLQ scores compared with placebo-treated subjects (p = 0.004). After 1 week, cetirizine produced significant improvements in the nasal symptoms, practical problems, and activities RQLQ domain scores compared with placebo (p < 0.05). After 4 weeks, cetirizine-treated subjects reported significant reductions in these RQLQ domain scores and in emotion domain scores compared with placebo-treated subjects (p < 0.05). Cetirizine 10 mg daily produced significant improvements in symptom severity and allergic rhinitis-related QOL compared with placebo in adults with PAR.

Allergen immunotherapy (AIT) is used for the treatment of allergic rhinoconjunctivitis as a subcutaneous injection (subcutaneous immunotherapy [SCIT]). Extracts used for SCIT are also used off-label to formulate a liquid delivered as sublingual drops (sublingual immunotherapy [SLIT]). This study was designed to survey patients' experiences and beliefs regarding SCIT and SLIT. People who had ever been diagnosed with nasal and/or ocular allergies were identified in a 2012 telephone survey of U.S. households. Respondents were asked questions about their or their child's use of SCIT and SLIT and their beliefs about AIT. Of 2765 respondents, 46.5% had ever heard of AIT and 22.7% had ever initiated it: 20.9% with SCIT and 1.8% with SLIT (p < 0.0001). The most frequently cited reason for beginning AIT was that symptoms were unresolved with other medications (SCIT, 32.1%; SLIT, 14.0%). Some or full symptom relief was reported by 74.9% of respondents treated with SCIT and 66.0% of those treated with SLIT (p = 0.17 for SCIT versus SLIT). Approximately one-third of respondents who had ever heard of or had been treated with AIT said "don't know" when asked if immunotherapy controls allergy symptoms for years (33.6%), is a very safe treatment (29.3%), or can cure allergy symptoms (27.5%). Effective relief of allergy symptoms was cited most often as the primary benefit of SCIT (37.8%) and convenience was the primary benefit of SLIT (14%). Only one-fifth of respondents had ever been treated with AIT, largely with SCIT. More than one-half of respondents had never heard of AIT and respondents' beliefs indicated a need for educational efforts.

Previous nationwide surveys of allergies in the United States have focused on nasal symptoms, but ocular symptoms are also relevant. This study determines the effects of ocular and nasal allergies on patients' lives. Telephone surveys of randomly selected U.S. households (the patient survey) and health care providers (provider survey) were conducted in the United States in 2012. Study participants were 2765 people ≥5 years of age who had ever been diagnosed with nasal or ocular allergies and 500 health care providers in seven specialties. Respondents to the patient survey reported a bimodal seasonal distribution of allergy symptoms, with peaks in March to May and September. Nasal congestion was the most common of the symptoms rated as "extremely bothersome" (39% of respondents), followed by red, itchy eyes (34%; p = 0.84 for difference in extreme bothersomeness of nasal and ocular symptoms). Twenty-nine percent of respondents reported that their or their child's daily life was impacted "a lot" when allergy symptoms were at their worst. Workers rated their mean productivity at 29% lower when allergy symptoms were at their worst (p < 0.001 compared with no symptoms). Providers reported that itchy eyes was the symptom causing most patients to seek medical treatment by pediatricians (73%), ophthalmologist/optometrists (72%), and nurse practitioners or physician assistants (62%), whereas nasal congestion was the symptom causing most patients to seek treatment from otolaryngologists (85%), allergist/immunologists (79%), and family medicine practitioners (64%). Ocular and nasal allergy symptoms substantially affected patients' lives and were comparable in their impact.

Background: The bronchodilatory effect of mometasone furoate/formoterol fumarate (MF/F) administered by metered-dose inhaler (MDI) with or without a spacer has not been evaluated previously in children aged 5-11 years., Methods: This was a randomized, multicenter, placebo-controlled, single-dose, four-period crossover study. Children with persistent asthma aged 5-11 years participated in this study. Subjects used inhaled corticosteroids with/without long-acting beta-2 agonists for 12 weeks before enrollment and at screening had forced expiratory volume in 1 sec (FEV1 ) ≥70% predicted. Subjects received MF/F MDI 100/10 µg with/without spacer (AeroChamber Plus® with Flow-Vu® Anti-Static Valved Holding Chamber), F-Dry Powder Inhaler (F-DPI) 10 µg, and placebo MDI with/without spacer in separate treatment periods. The primary endpoint was FEV1 area under the curve from 0 to 12 hr (AUC0-12hr ) for the comparison of MF/F with spacer versus placebo. Secondary measurements included MF/F without spacer versus placebo, as well as MF/F with spacer versus MF/F without spacer, and F-DPI versus placebo. Analysis was performed with an analysis of covariance model for a crossover study., Results: Data from 87 subjects were analyzed. MF/F with spacer demonstrated a larger change in mean FEV1 AUC0-12hr versus placebo (115 vs. -9 mL), with a treatment difference of 124 mL (95% CI 94-154, P < 0.001). Similarly, MF/F without spacer versus placebo resulted in a 102 mL difference in mean-adjusted FEV1 AUC0-12hr (95% CI 73-131, P < 0.001), whereas the difference between MF/F with spacer versus MF/F without spacer was 22 mL (95% CI -8 to 52, P = 0.144). The difference between F-DPI versus placebo was 106 mL (95% CI 77-135, P < 0.001). No unexpected adverse events were observed., Conclusions: In this trial, MF/F MDI 100/10 µg demonstrated significant bronchodilation in children aged 5-11 years regardless of the use of a spacer. No difference in bronchodilation was observed between MF/F MDI and F-DPI., (© 2013 Wiley Periodicals, Inc.)

Background: Allergic rhinoconjunctivitis (ARC) is managed by a number of health care professional specialties, whose practice styles may vary., Objective: To survey patients and health care professionals about the diagnosis and treatment of ARC., Methods: The Allergies, Immunotherapy, and RhinoconjunctivitiS (AIRS) surveys were telephone surveys of randomly selected patients and health care professionals in the United States in 2012. Participants were 2,765 people ever diagnosed as having nasal and/or ocular allergies and 500 practitioners in 7 specialties who were treating ARC., Results: Adult respondents to the patient survey reported that their allergies had been diagnosed most often by physicians in family practice (46%) rather than by allergists/immunologists (17%) or otolaryngologists (11%). Children's allergies had been diagnosed most often by pediatricians (41%) and family practitioners (22%). Most respondents with conditions diagnosed by an allergist/immunologist (94.9%) or otolaryngologist (62.7%) had been given an allergy test, but the test was not given to most patients with conditions diagnosed by family practitioners (61.3%) or pediatricians (64.9%). Most patients (75.8%) were treating their allergies with over-the-counter medications, and 53.5% were taking prescription medications. Allergen immunotherapy was being used by 33% (adult) or 28% (child) patients of allergist/immunologists, 25% (adult) or 24% (child) patients of otolaryngologists, and 8% and 10% of patients of family practitioners and pediatricians, respectively., Conclusion: Most patients took nonprescription medications for their allergy symptoms or were treated by general practitioners, who did not use allergy testing when diagnosing ARC. Most patients seen by allergist/immunologists and otolaryngologists were evaluated with allergy tests, and most allergen immunotherapy was provided by allergy specialists., (Copyright © 2014 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Background: The prevalence of asthma and obesity in children has increased over the past several years, with obesity being associated with higher rates of asthma. In response to known disparities in asthma prevalence and morbidity, along with barriers to diagnosis, assessment and education, a comprehensive asthma sports camp series was developed and implemented., Objective: The primary objective was to evaluate the effectiveness of utilizing a sports camp model to identify children with undiagnosed and uncontrolled asthma, and to provide recommendations for follow-up care. The secondary objectives were to identify the presence of and associations between related co-morbidities and risk factors for asthma morbidity such as obesity, hypertension and exposure to tobacco smoke; and to assess asthma medication use., Methods: Six daylong camps at an inner-city university were offered to children 5-17 years of age over a period of two years. Asthma, body mass index, blood pressure (BP) and carbon monoxide screenings were conducted at each camp., Results: In this sample, 43.7% of children had previously diagnosed asthma, and 12.6% were classified as having potential, undiagnosed asthma. Of the children with previously diagnosed asthma, 76% were considered uncontrolled. Thirty-eight percent were determined to be overweight or obese and 17% had elevated BP., Conclusions: An interdisciplinary sports camp model can be used to identify children with undiagnosed and uncontrolled asthma and cardiovascular risk factors; and to provide recommendations for follow-up care.

Inhaled corticosteroids (ICSs) are an effective therapy for the treatment of persistent asthma of all severities because they reduce symptoms, improve lung function, and reduce underlying inflammation. Although ICSs are generally safe for long- term use, there is concern among physicians and patients about potential systemic side effects, including growth inhibition in children. This continued concern of systemic side effects may negatively affect the compliance to ICS treatment. Based on the current guidance to industry from the Food and Drug Administration (FDA), some efficacy and safety studies on ICSs performed in the 1990s had limitations in their design to evaluate the effect of ICS therapy on growth as a safety end point. A review of studies performed with currently available ICSs and their level of conformance with the FDA guidance are presented in this article. The 1-year studies show a small, dose-dependent effect of most ICSs on childhood growth, with some differences across various ICS molecules and across individual children. Some ICSs at the doses studied did not affect childhood growth using rigorous study designs. Most studies did not conform completely with the FDA guidance. The data on effects of childhood ICS use on final adult height are conflicting, but one recent well-designed study showed an effect, clearly warranting additional studies.

Objective: To assess the effects of long-term mometasone furoate delivered via a dry powder inhaler (MF-DPI) on growth velocity and hypothalamic-pituitary-adrenal axis function in children with asthma., Study Design: Children aged 4-9 years with asthma (n = 187) were randomized to MF-DPI 100 μg (delivered dose; actuated dose is 110 μg) once daily in the morning (QD AM), 100 μg twice daily (BID), 200 μg QD AM, or placebo for 52 weeks followed by a 3-month follow-up period. The primary outcome was growth velocity calculated from stadiometric heights recorded at each visit. Secondary outcomes included serum and 12-h urinary cortisol, serum osteocalcin, and urinary N-telopeptide., Results: MF-DPI 100 μg QD AM treatment did not significantly affect growth velocity compared with placebo (-0.10 ± 0.31 cm/y, p = 0.76). When the effect of a total daily dose of 200 μg MF-DPI on growth velocity was examined, no significant effect was demonstrated for MF-DPI 100 μg BID compared with placebo (-0.64 ± 0.39 cm/y, p = 0.10), although the change in mean growth velocity with MF-DPI 200 μg QD AM reached statistical significance (-0.70 ± 0.29 cm/y, p = 0.02). The effects of all examined doses of MF-DPI on mean plasma cortisol levels were similar to cortisol changes seen in the placebo group, suggesting an absence of drug-related effects. No differences in 12-h urinary cortisol or other outcomes were observed between groups., Conclusions: One year of treatment with a total daily dose of 100 μg of MF-DPI in the morning resulted in no significant difference, whereas a total daily dose of 200 μg of MF-DPI was associated with some changes in growth velocity when compared with placebo. The differences in growth velocity, and the absence of drug-related cortisol effects, support the use of a total daily dose of 100 μg of MF-DPI in children aged 4-9 years with mild persistent asthma.

Sublingual immunotherapy (SLIT) is a well-established treatment option for allergic rhinitis in several European countries, but it is considered investigational in the United States. Studies conducted in Europe provided a large body of evidence supporting the safety and efficacy of SLIT, but those studies used allergen products that are different from those that are likely to be approved in the United States, and many of them were not controlled, randomized, double-blinded trials. This review summarize research conducted on the efficacy, safety, and mechanisms of SLIT published during the past year, with a focus on ragweed and grass antigens. Results of recent US studies document the safety and efficacy of SLIT and have started to yield insight into the mechanisms of SLIT.

Background: Allergy immunotherapy tablet (AIT) treatment might be a safe and convenient form of specific immunotherapy but it has not been investigated in North American children and adolescents., Objective: We sought to investigate the efficacy and safety of timothy grass AIT treatment in North American children/adolescents with grass pollen-induced allergic rhinoconjunctivitis (ARC) with or without asthma., Methods: Three hundred forty-five subjects (5-17 years old) were randomized to once-daily grass AIT treatment (2,800 bioequivalent allergen units, 75,000 standardized quality tablet, approximately 15 μg of Phl p 5) or placebo approximately 16 weeks before the 2009 grass pollen season (GPS). Treatment continued through the GPS. Daily symptoms and allergy rescue medication use were recorded. The primary end point was the total combined score (TCS) of the daily symptom score (DSS) and daily medication score (DMS) for the entire GPS. DSS, DMS, Rhinoconjunctivitis Quality of Life Questionnaire score, and Phl p 5-specific IgG4 and IgE-blocking factor levels were secondary end points. Safety was assessed through adverse events., Results: Eighty-nine percent of subjects were multisensitized. TCS, DSS, DMS, and Rhinoconjunctivitis Quality of Life Questionnaire score versus placebo improved 26% (P = .001), 25% (P = .005), 81% (P = .006), and 18% (P = .04). Phl p 5-specific IgG4 and IgE-blocking factor levels were significantly higher at the peak and end of the GPS (P < .001). Treatment was well tolerated. Adverse events were generally mild and transient. Although no investigator-assessed systemic allergic reactions were reported, 1 grass AIT-treated subject experienced an event indicating a systemic reaction (lip angioedema, dysphagia, and cough)., Conclusions: Use of once-daily timothy grass AIT treatment effectively treats timothy grass (cross-reactive with Festucoideae grasses) pollen-induced ARC in North American children 5 years and older. Given its convenient administration, lack of dose build-up requirement, safety profile, and efficacy, AIT treatment might become an important addition to the North American ARC treatment armamentarium., (Copyright © 2010 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.)

Small-particle inhaled corticosteroid (ICS) metered-dose inhalers were recently developed to treat asthma as part of the CFC to HFA propellant switch mandated by the Montreal Protocol. Two such ICS, beclomethasone dipropionate (BDP) and ciclesonide (CIC), are available in the United States and are formulated in HFA solutions. A major advantage of small-particle ICS is that they have improved total lung deposition and consequently, effective asthma control is achieved at lower daily doses than the large-particle ICS. Another advantage of small-particle ICS is that they are able to reach the small airways and consequently, may result in increased efficacy. Indeed, recent studies have demonstrated the effect of small-particle ICS on asthmatic inflammation in the small airways. Another advantage of small-particle ICS is that they may have an improved safety profile. Small-particle inhalers generally deposit decreased amounts of drug in the oropharynx than their CFC counterparts possibly resulting in a lower incidence of oropharyngeal candidiasis. However, growth studies and most HPA studies do not support improved safety on the basis of particle size alone and some studies suggest even higher systemic bioavailability and safety risk with smaller particles, depending on the molecule and the formulation. Further efficacy and safety studies are clearly warranted to determine any potential advantages of small-particle ICS, particularly in long-term disease modification where large-particle ICS have failed, and in infants and pre-schoolers, in whom airway delivery is problematic with current formulations., (Copyright 2010 Elsevier Ltd. All rights reserved.)

Corticosteroids are the foundation of pharmacologic treatment for children with asthma. However, high-dose inhaled corticosteroid treatment can cause hypothalamic-pituitary-adrenal (HPA) axis suppression. We investigated the effect of three doses of mometasone furoate administered via dry-powder inhaler (MF-DPI) on the HPA axis in children. Fifty children (6-11 years) with mild asthma of > or =6 months' duration were randomized to MF-DPI, 100 (n = 13), 200 (n = 13), or 400 micrograms b.i.d. (n = 12), or placebo (n = 12) for 29 days. The primary end point was change from baseline in the 12-hour area under the plasma-cortisol-concentration-time curve (AUC). Secondary parameters included plasma cortisol response to cosyntropin stimulation and 24-hour urinary free cortisol concentrations. Compared with placebo, AUC changes associated with treatments of MF-DPI, 100 or 200 micrograms b.i.d., were not significant, whereas a significant change was observed with MF-DPI, 400 micrograms b.i.d. (27%; p = 0.05). Responses to cosyntropin stimulation and urinary cortisol measurements were similar to placebo with all MF-DPI doses. All regimens were well tolerated. MF-DPI did not have a significant effect on plasma or urinary cortisol levels at doses up to 200 micrograms b.i.d. in children with mild asthma. Higher MF-DPI doses may potentially suppress the HPA axis.

Otitis media (OM) is a common and costly medical condition, especially in children. Most episodes of OM are associated with an upper respiratory viral infection and are short-lived and self-limiting with or without medical treatment. However, chronic OM with effusion (OME) has significant sequelae, is refractory to most medical treatments, and frequently requires surgical intervention. The pathophysiology of OME is complex and involves both eustachian tube (ET) dysfunction and middle ear pressure dysregulation. OM likely results from an increase in blood flow to and, thus, gas loss from the middle ear, in combination with a dysfunctional ET that can not resupply that gas. These processes could be induced by viral and/or allergen-driven inflammation. A large body of epidemiologic and mechanistic evidence supports a role for allergic rhinitis as a risk for OM. Indeed, evidence also supports a role for histamine in both conditions. However, not all such evidence is supportive of this relationship and a causal relationship between the two conditions has not been definitively proven. Moreover, therapeutic trials using common allergy therapies have either not been conducted or showed no benefit in OM. This prompted the 2004 clinical practice guidelines on OM to conclude that no recommendations could be made for "... allergy management as a treatment for OME based on insufficient evidence of therapeutic efficacy or a causal relationship between allergy and OME." Nonetheless, given the strong likelihood of allergy as a risk factor for OM, allergic rhinitis patients should be evaluated for OM and patients with OME should be considered for an allergy evaluation. If significant allergic rhinitis is diagnosed in a patient with OME, it should be treated aggressively (as in any case of moderate to severe allergic rhinitis) until further studies are conducted. No definitive conclusions about a role for food allergy in causing or treating OM can be made. Clearly, more studies are needed to examine the relationship between these two important conditions.

Ciclesonide is a novel inhaled corticosteroid used in the continuous treatment of mild-to-severe asthma. Its formulation and mechanism of action yield a low oral and systemic bioavailability, and high pulmonary deposition. In multiple clinical trials, ciclesonide is at least as effective as either fluticasone propionate or budesonide at symptom control, while in many cases having improved safety outcomes and tolerability. The improved safety and comparable efficacy profiles of ciclesonide demonstrated in current studies could potentially yield a treatment option that may lead to improved adherence and outcome.

Purpose: This study assessed the efficacy and safety of guaifenesin 600 mg and pseudoephedrine hydrochloride 60 mg extended-release bilayer tablets in providing relief of acute respiratory symptoms when used as an adjunct to antibiotics in patients with an acute respiratory infection (ARI)., Methods: Adult patients experiencing symptoms of ARI and meeting the physician's usual diagnostic criteria for oral antibiotic treatment were prescribed an antibiotic and randomized to adjunctive guaifenesin/pseudoephedrine hydrochloride or matching placebo twice daily for 7 days. Patients completed symptom diaries and treatment assessments twice daily and attended office visits on Days 4 and 8., Results: The safety/intent-to-treat (ITT) population analysis included 601 patients (guaifenesin/pseudoephedrine, n = 303; placebo, n = 298). Mean symptom scores were lower with guaifenesin/pseudoephedrine from Day 3 for every symptom assessed, with statistically significant improvements in total symptom score from Day 3 (P = 0.026). The greatest effects of treatment with guaifenesin/pseudoephedrine were observed for nasal congestion and sinus headache. Time to overall relief was shorter with guaifenesin/pseudoephedrine (P = 0.038). Significantly more patients reported "the medication was helping during the day" on Day 2 with guaifenesin/pseudoephedrine (P = 0.002). Patient assessments of symptom relief showed a significant preference for guaifenesin/pseudoephedrine versus placebo (P = 0.021). Treatment with guaifenesin/pseudoephedrine was well tolerated. Insomnia (2.6%), nausea (2.3%), and headache (1.3%) were the most common treatment-related adverse effects., Conclusions: As adjunctive therapy for symptom relief for patients taking antibiotics for ARIs, guaifenesin/pseudoephedrine shortened time to relief and improved bothersome respiratory symptoms better than placebo, with greatest effects seen for nasal congestion and sinus headache.

Inhaled corticosteroids (ICSs) are the preferred first-line preventative therapy for asthma of all severity levels. Although these drugs have been proven efficacious, concerns of adverse systemic affects due to both long- and short-term use continue to limit patient compliance with dosing regimens. Deficits in bone growth, bone density, and hypothalamic-pituitary-adrenal axis function, in addition to cataract formation and elevated intraocular pressure/glaucoma, have been associated with ICS use in some studies. Although some of these studies were flawed, featured drugs that are less commonly prescribed today, or both, adverse effects from chronic ICSs use are still a cause of concern today. Current therapies are designed to be efficacious at minimal doses, limiting potential side effects, increasing adherence, and improving asthma control.

Inhaled corticosteroids (ICS) are the guideline-preferred preventative therapy for persistent asthma of all severity levels and for all ages, including children. While these drugs are unquestionably efficacious, concerns of adverse systemic effects limit patient compliance with treatment regimens and thus the attainable benefits. Suppression of bone growth, bone density, and HPA axis function, in addition to cataract formation and elevated intraocular pressure/glaucoma, have been associated with ICS use. This review will focus on recent developments in the safety and efficacy of ICS as compared to oral CS corticosteroids and the achievement of a balance between risk and benefit in optimizing ICS therapy.

Antihistamines are used frequently in adult and pediatric patients as first-line treatment for both allergic rhinitis and urticaria. There are several different antihistamines on the market, generally divided into first- and second-generation products. Although many of these show efficacy, there are significant differences in the side effect profiles of these medications, with resultant differences in their effect on quality of life and other outcomes. Although the most significant differences are between generations, there are considerations even within generations, especially regarding sedation and possible effects on learning. Other than specific situations in which sedation may be a desired effect, the second-generation antihistamines generally are preferred and the risks and benefits of individual drugs within this group need to be considered for each patient's specific circumstances.