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Resumen Introduccion La reconstruccion de base de craneo constituye uno de los mayores retos de la cirugia endoscopica endonasal expandida. Existen multitud de injertos y colgajos de origen endonasal que han demostrado su utilidad en el control de complicaciones como las fistulas de LCR, entre otras. Se hace necesaria la revision y el analisis de los recursos endonasales y su uso en cirugia endoscopica endonasal expandida. Objetivos Documento de consenso sobre el uso de los distintos injertos y colgajos de origen endonasal y su uso en cirugia endoscopica endonasal expandida. Material y metodos Revision bibliografica sobre los injertos libres y colgajos vascularizados de origen endonasal mas relevantes. Analisis mediante el metodo Delphi, sobre el uso de los distintos recursos endonasales para la reparacion endoscopica de defectos de base de craneo. Resultados Se obtuvieron dos resultados. 1) Una seleccion de los colgajos e injertos de origen endonasal mas representativos, describiendo origen, superficie e indicaciones, a partir de una revision bibliografica. 2) Un documento de consenso, utilizando la metodologia Delphi, con las consideraciones generales (2), recomendaciones (10) y limitaciones (6) sobre el uso de los distintos colgajos e injertos de origen endonasal. Conclusiones Presentamos el primer documento de consenso en el campo de la cirugia endoscopica endonasal utilizando el metodo Delphi como herramienta de trabajo. Se destaca la utilidad del colgajo nasoseptal junto con el resto de colgajos e injertos de origen endonasal para la cirugia reconstructiva de base de craneo.

Resumen La rinosinusitis cronica con polipos nasales (RSCcPN) es una enfermedad con gran impacto sobre la salud. La opcion quirurgica mediante cirugia endoscopica nasosinusal es la alternativa terapeutica cuando no se alcanza el control de la enfermedad con el tratamiento medico. Los abordajes endoscopicos extensos se estan postulando como posible mejor opcion de tratamiento quirurgico en ciertos fenotipos de RSCcPN. La mucoplastia endonasal asociada a estos abordajes ha demostrado ser una tecnica complementaria que mejora tanto la cicatrizacion como el edema mucoso a corto plazo en pacientes con RSCcPN. El objetivo de nuestro estudio ha consistido en analizar los resultados de las mucoplastia endonasal asociada a una etmoidoesfenoidotomia completa mas sinusotomia frontal de grado III en el tratamiento de RSCcPN a medio plazo. Para ello se realizo un estudio prospectivo de casos y controles (10/10) en pacientes con RSCcPN. En el grupo de casos se asocio a la cirugia una mucoplastia endonasal en la fosa nasal izquierda y en el grupo control no. La evaluacion de la calidad de vida al ano de la intervencion quirurgica, medida mediante la diferencia de medias de SNOT-22 (media [DE]), en el grupo de casos fue significativamente mejor que en el grupo control (45,9 [19,6]-26,6 [16,05]; p = 0,027). La mejoria endoscopica de la cicatrizacion y del edema mucoso, medida mediante la escala de Lund-Kennedy modificada, mostro mejorias relevantes al comparar ambas fosas, pero sin alcanzar la significacion (p = 0,29). La mucoplastia endonasal favorece la cicatrizacion a corto plazo, lo que mejora la calidad de vida a medio plazo (un ano) de los pacientes tratados con resecciones extensas endoscopicas de los senos.

Chronic rhinosinusitis with nasal polyps (CRSwNP) is a disease with great impact on health. The surgical option using endoscopic sinus surgery is the therapeutic alternative when control of the disease is not achieved with medical treatment. Extensive endoscopic approaches are being postulated as a possible best surgical treatment option in certain phenotypes of CRSwNP. Endonasal mucoplasty associated with these approaches has been shown to be a complementary technique that improves both healing and mucosal edema in patients with CRSwNP in the short term. The aim of our study was to analyse the results of endonasal mucoplasty associated with a complete ethmoid-sphenoidotomy plus grade III frontal sinusotomy in the treatment of CRSwNP in the medium term. For this purpose, a prospective case-control study (10/10) was carried out on patients with CRSwNP. In the case group, endonasal mucoplasty in the left nostril was associated with surgery, and the control group was not. The assessment of quality of life at one year after surgery, as measured by the mean difference in SNOT-22 (mean [SD]), was significantly better in the case group than in the control group (45.9 [19.6]-26.6 [16.05] P=0.027). The endoscopic improvement in healing and mucosal edema, measured by the Modified Lund-Kennedy scale, showed relevant improvements, when comparing both nostrils, but without reaching significance (P=0.29). Endonasal mucoplasty promotes short-term healing, improving the quality of life in the medium term (one year) of patients treated with extensive endoscopic mucosal resections.

Objectives To perform a radio‐anatomical evaluation of the nasal cavity floor free mucosal graft (endonasal extended mucoplasty, EEM) to repair mucosal defects after an extended ethmoid‐sphenoidotomy. Methods A human cadaveric study (radiological and anatomical dissection) and an in vivo study in surgical patients with CRSwNP were performed. The EEM areas were compared between 3D reconstruction from CT scans and anatomical/surgical dissections, both in cadaver specimens and in patients. Feasibility was assessed by correlation between the EEM area on CT scans and when harvested in cadavers and when grafted in patients. Usefulness was assessed by the degree of coverage of the EEM in the surface exposed after an extended ethmoid‐sphenoidotomy. Both feasibility and usefulness were assessed in cadaveric specimens (n = 15) and patients (n = 4). Results Fifteen cadaveric specimens and 4 patients with bilateral CRSwNP were included. The mean (SD) areas obtained in the cadaveric radiological and anatomical studies were 9.44 (2.07) cm2 and 8.03 (1.36) cm2, respectively (intraclass correlation coefficient 0.59, moderate correlation), and in 3D reconstruction for operated patients were 10.32 (0.98) cm2 and 11.27 (2.44) cm2, respectively. The coverage of the ethmoidal roof in the cadaveric dissection study was 100%, from the anterior ethmoidal artery to the posterior ethmoidal artery, covering the planun sphenoidale up to 75% in the case series. In 87.5% of the cases, up to 50% of the papiracea lamina was covered. Conclusion The EEM have shown to be a feasible and useful grafting technique to repair skull base defects after performing an extended ethmoid‐sphenoidotomy during surgery for CRSwNP. Level of Evidence NA.

El objetivo de esta revisión es facilitar al neumólogo el manejo de las enfermedades de la vía respiratoria superior ligadas a la vía respiratoria inferior, especialmente al asma, unidas por una epidemiología, una clínica y un mecanismo inflamatorio comunes e interrelacionados. El documento recoge las definiciones de los diferentes fenotipos nasosinusales ligados al asma: rinitis alérgica o no alérgica y rinosinusitis crónica con o sin pólipos nasales. Asimismo se recogen los criterios diagnósticos y su nivel de gravedad. Se dedica especial atención a los dos síndromes principales asociados al asma: 1) rinitis alérgica, la patología más frecuente, y 2) rinosinusitis crónica con pólipos nasales, la patología más ligada al asma grave. En síntesis, en el manejo del asma debe valorarse siempre la vía respiratoria superior con la finalidad de un diagnóstico unificado y un tratamiento integral de la vía respiratoria única.

The COVID-19 outbreak has spread extensively around the world. Loss of smell and taste have emerged as main predictors for COVID-19. The objective of our study is to develop a comprehensive machine learning (ML) modelling framework to assess the predictive value of smell and taste disorders, along with other symptoms, in COVID-19 infection. A multicenter case-control study was performed, in which suspected cases for COVID-19, who were tested by real-time reverse-transcription polymerase chain reaction (RT-PCR), informed about the presence and severity of their symptoms using visual analog scales (VAS). ML algorithms were applied to the collected data to predict a COVID-19 diagnosis using a 50-fold cross-validation scheme by randomly splitting the patients in training (75%) and testing datasets (25%). A total of 777 patients were included. Loss of smell and taste were found to be the symptoms with higher odds ratios of 6.21 and 2.42 for COVID-19 positivity. The ML algorithms applied reached an average accuracy of 80%, a sensitivity of 82%, and a specificity of 78% when using VAS to predict a COVID-19 diagnosis. This study concludes that smell and taste disorders are accurate predictors, with ML algorithms constituting helpful tools for COVID-19 diagnostic prediction.

Background: Allergic conjunctivitis (AC) is usually associated to allergic rhinitis (AR), but the severity and control of ocular symptoms should be assessed independently to improve diagnosis and treatment. The criteria from the Spanish consensus document on allergic conjunctivitis (DECA) aimed to be used as a patient-reported instrument for AC management. Here we validate these criteria for classifying AC severity and defining its control following COSMIN guidelines recommendations. Methods: Patients with moderate or severe AR [reflective total nasal symptom score (rTNSS) score ≥ 8] and concomitant AC were recruited from hospitals in Spain. Patients were classified according to the severity of ocular symptoms as mild, moderate, or severe, and classified with respect to control as controlled and non-controlled, using the DECA criteria. To validate these criteria, comparisons with the validated modified allergic rhinitis and its impact on asthma (mARIA), reflective total ocular symptom score (rTOSS), rhinitis control assessment test (RCAT), ESPRINT-15 questionnaires, a conjunctival hyperemia scale and a visual analogue scale (VAS) for ocular symptoms were performed. Results: A total of 128 patients participated in the validation. Mean age was 34.4 ± 12.1 years; 72.7% were women. The DECA criteria showed a good discriminant validity, reflecting a high capacity to differentiate between mild, moderate, and severe patients, and controlled from uncontrolled patients. A strong association between AC and AR was reflected in the comparison between the DECA and the mARIA criteria (p < 0.0001). The DECA criteria for severity and control presented satisfactory properties for longitudinal validity and responsiveness. Conclusions: Validation of the DECA criteria for severity and control of AC suggested that it can be useful in the evaluation of eye symptoms and follow-up of therapies, This study was funded by Meda Pharma SL (a Mylan company)

Rhinitis is an umbrella term of a group of upper airway diseases with nasal symptoms and signs with different etiologies and various clinical features or traits. It can be classified into different "phenotypes," based on these observable traits. A proper differential diagnosis is necessary to adequately manage the disease. The objective of this review is to clarify the concept of rhinitis phenotypes while analyzing the clinical features and/or traits of each in order to determine a proper differential diagnosis and appropriate treatment.

Background Allergic rhinitis (AR) is the most common chronic disease in children. The main objective of this study was to analyze the comorbidities and therapeutic approaches for AR in a Spanish pediatric population. Methods Children aged 6 to 12 years with AR were included in an observational, cross-sectional, multicenter study. Results 1,275 children were recruited from 271 centers. AR was intermittent in 59.5% of cases, persistent in 40.5%, seasonal in 60.7%, and perennial in 39.3% of patients. The most frequent comorbidities were conjunctivitis (53.6%), asthma (49.5%), atopic dermatitis (40%), rhinosinusitis(26.1%), otitis media (23.8%), and adenoid hypertrophy (17.3%). Overall, patients with persistent, moderate or severe, AR were more likely to present comobidities, except for food allergy and urticaria. The most common drugs used for treatment of AR were oral antihistamines(76%), nasal corticosteroids(49%) and a combination of both (45%). Antihistamines and nasal corticosteroids were used on demand (

Allergic rhinitis (AR) is the commonest chronic disease in children. Allergic Rhinitis and its Impact on Asthma (ARIA) classification based on symptom duration (intermittent vs. persistent) and severity (mild vs. moderate/severe) has not been yet validated in children. Thus our objective was to validate ARIA classification in children, after determining the severity and duration of AR in a pediatric population, using ARIA definitions. Children aged 6-12 with a diagnosis of AR were included in an observational, cross-sectional, multicenter study. Patients were classified according to ARIA guidelines. AR symptoms were assessed using the Total Four Symptoms Score (T4SS). Severity was also evaluated by the patient using a visual analogue scale (VAS). Comparisons were made by means of a statistical analysis. One thousand two hundred and seventy-five children from 271 centers were included. Among them, 59.5% had intermittent and 40.5% persistent AR, while 60.7% seasonal and 39.3% perennial according to dated classification, with significant differences existing between one classification and another; 89.7% had moderate/severe rhinitis. Significantly higher T4SS and VAS scores were obtained in moderate/severe compared to mild AR. In our experience, the current ARIA classification can be considered a valid tool also in children from 6- to 12-yr old.

Background: The objective of the OLFAPEDRIAL study was to assess the olfactory dysfunction in allergic paediatric population, which has been scarcely studied. Methods: Observational, cross-sectional and multicentre study evaluated the sense of smell in untreated allergic rhinitis (AR) paediatric patients aged 6-12 years. Results: Forty-four per cent (551 of 1260) of children with AR reported smell dysfunction, with both loss of smell frequency (52.1%, p < 0.001) and intensity (0.75 +/- 0.84, p < 0.0001) being more frequent in patients with persistent than intermittent AR (38.0% and 0.51 +/- 0.73, respectively). In addition, both loss of smell frequency and intensity increased according to disease severity (m-ARIA classification) but always being significantly higher in persistent (p < 0.0001) than in intermittent AR. Conclusions: Children with allergic rhinitis present a mild-moderate loss of smell frequency and intensity which is clearly related to the disease duration and severity. The loss of smell can be considered, as in adults, a clinical marker of disease severity.

Urticaria is a highly prevalent disease among people. First-choice treatment continues to be centred on the second-generation H1 antihistamines, including a wide group of drugs with a better therapeutic index (or risk:benefit ratio) than the classic ones, even in the high, off-label dosage occasionally required in chronic urticaria. Bilastine is a newly registered H1-antihistamine for treatment of allergic rhinoconjunctivitis and urticaria. With established antihistaminic and antiallergic properties, it is widely reviewed in the medical literature; however, to our knowledge, a specific review of bilastine's role in the treatment of urticaria was lacking.This article reviews the medical literature on the effectiveness and safety of bilastine in urticarial syndromes, either spontaneous or inducible, by means of a Medline search from 1990 to present, completed with some nonpublished data provided by the manufacturer.Once-daily treatment with bilastine 20 mg is effective in managing symptoms and improving patient's quality of life in chronic urticaria, with at least comparable efficacy to levocetirizine. As far as studies in healthy volunteers, clinical assays, and recent clinical experience can establish, bilastine's safety profile is adequate, appearing to be entirely free from cardiovascular effects, and not impairing psychomotor performance or actual driving, even at twice the therapeutic dose.

Background There is an increase in the incidence of pollen related allergy, thus information on pollen schedules would be a great asset for physicians to improve the clinical care of patients. Like cypress pollen sensitization shows a high prevalence among the causes of allergic rhinitis, and therefore it is of interest to use it like a model of study, distinguishing cypress pollen, pollen count, and allergenic load level. In this work, we use a flow cytometry based technique to obtain both Cupressus arizonica pollen count and allergenic load, using specific rabbit polyclonal antibody Cup a1 and its comparison with optical microscopy technique measurement. Methods Airborne samples were collected from Burkard Spore-Trap and Burkard Cyclone Cupressus arizonica pollen was studied using specific rabbit polyclonal antibody Cup a1, labeled with AlexaFluor® 488 or 750 and analysed by Flow Cytometry in both an EPICS XL and Cyan ADP cytometers (Beckman Coulter®). Optical microscopy study was realized with a Leica optical microscope. Bland and Altman was used to determine agreement between both techniques measured. Results We can identify three different populations based on rabbit polyclonal antibody Cup a1 staining. The main region (44.5%) had 97.3% recognition, a second region (25%) with 28% and a third region (30.5%) with 68% respectively. Immunofluorescence and confocal microscopy showed that main region corresponds to whole pollen grains, the second region are pollen without exine and the third region is constituted by smaller particles with allergenic properties. Pollen schedule shows a higher correlation measured by optical microscopy and flow cytometry in the pollen count with a P-value: 0.0008 E−2 and 0.0002 with regard to smaller particles, so the Bland and Altman measurement showed a good correlation between them, P-value: 0.0003. Conclusion Determination of pollen count and allergenic load by flow cytometry represents an important tool in the determination of airborne respiratory allergens. We showed that not only whole pollen but also smaller particles could induce allergic sensitization. This is the first study where flow cytometry is used for calculating pollen counts and allergenic load. © 2013 International Clinical Cytometry Society

Introduction: Allergic rhinitis (AR) is a common disease with major socieconomic burden and a significant impact on quality of life. Objective: The objective of the study was to assess the impact of AR severity, using the modified ARIA (m-ARIA) severity criterion in order to discriminate among moderate and severe AR, in symptoms and quality of life assessed with the questionnaire ESPRINT-15. Methods: The specific quality of life questionnaire (ESPRINT-15) was applied in over thousand untreated RA patients. Severity was evaluated by the m-ARIA classification, which categorizes AR as mild, moderate, and severe. Nasal symptoms were evaluated by using categorized (none, low, middle, and high) Total Four Symptom Score (T4SS). Results: Using the m-ARIA severity classification, significant differences in quality of life, both global score and specific domains, and categorized T4SS were found among the AR severity groups. Conclusion: Modified ARIA severity classification in mild, moderate, and severe allergic rhinitis clearly discriminates the impact of AR in all domains of quality of life and categorized symptom`s score.

Allergic rhinitis (AR) is the commonest chronic disease in children. Allergic Rhinitis and its Impact on Asthma (ARIA) classification based on symptom duration (intermittent vs. persistent) and severity (mild vs. moderate/severe) has not been yet validated in children. Thus our objective was to validate ARIA classification in children, after determining the severity and duration of AR in a pediatric population, using ARIA definitions. Children aged 6-12 with a diagnosis of AR were included in an observational, cross-sectional, multicenter study. Patients were classified according to ARIA guidelines. AR symptoms were assessed using the Total Four Symptoms Score (T4SS). Severity was also evaluated by the patient using a visual analogue scale (VAS). Comparisons were made by means of a statistical analysis. One thousand two hundred and seventy-five children from 271 centers were included. Among them, 59.5% had intermittent and 40.5% persistent AR, while 60.7% seasonal and 39.3% perennial according to dated classification, with significant differences existing between one classification and another; 89.7% had moderate/severe rhinitis. Significantly higher T4SS and VAS scores were obtained in moderate/severe compared to mild AR. In our experience, the current ARIA classification can be considered a valid tool also in children from 6- to 12-yr old.

Introduction Allergic rhinitis (AR) is an increasingly prevalent worldwide disease, which has an important impact on quality of life and generates high social and health care costs. The ARIA classification, that considers both the duration and severity of AR, seems more appropriate than previous classifications of AR, but few studies exist on the validation of the severity criteria proposed by the ARIA classification. Objectives To assess the ARIA duration and severity classification of AR in a large sample population of patients, by investigating whether different degrees of severity correlate with differences in symptom score, quality of life or the patient's self evaluation of impairment. This study also assesses the relationship between AR severity and co morbidities. Material and methods An observational, cross-sectional, multicentre study conducted in Spain. AR was classified based on the ARIA criteria, and compared to the classical classification based on allergen exposure. Rhinitis was evaluated by the Total 4-Symptom Score (T4SS) scale, quality of life was measured using the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), and disease severity through a Visual Analogue Scale (VAS, 0-100 mm). Comorbidities were evaluated based both on the duration and severity of the symptoms of rhinitis. Results AR patients, (n = 3,529; mean age 37.5 +/= 13.4 years; 52.3% women) were included in the study. AR patients were classified as intermittent (51.5%) and persistent (48.5%) based on the ARIA classification, and as seasonal (61.2%), perennial (35.1%), and occupational (3.7%) based on the allergen exposure classification. Significantly higher T4SS, RQLQ and VAS scores were obtained in moderate/severe compared to mild AR. The incidence of asthma was significantly higher in patients with persistent and moderate/severe AR compared to intermittent and mild AR. Asthma was the only co morbidity to reach statistical significance. Conclusion ARIA classification of severity reflects two different statuses of AR in terms of symptoms and quality of life. Asthma was the only concomitant pathology in which incidence was related to ARIA categories in terms of duration or severity.

Background: Rupatadine (Rupafin®), a novel antihistamine approved recently in Europe for the treatment of allergic rhinitis (AR) and chronic idiopathic urticaria in patients aged ≥12 years, has been shown to be highly efficacious, and as safe and well tolerated as other commonly employed antihistamines in the treatment of allergic disease. There are, however, few data on the long-term safety of these antihistamines derived in accordance with the clinical safety recommendations of the European Agency for the Evaluation of Medicinal Products (EMEA) and the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use Guideline. Objective: To assess the safety and tolerability of treatment with rupatadine 10 mg/day for 12 months in subjects with persistent AR (PER). Methods: A multicentre, open-label, phase IV study in patients recruited from 33 centres in Spain, from September 2002 to November 2005. The study enrolled 324 male and female patients (aged 12–70 years) with a medical history of PER for at least 12 months and a documented positive skin-prick test to an appropriate allergen. On 4 of the 7 days prior to start of treatment, the patients were required to have a minimum total nasal symptom score (TNSS [for sneezing, rhinorrhoea, nasal obstruction/congestion and nasal itching]) of ≥5. Of the 324 eligible patients starting treatment, 120 needed to be treated for more than 6 months and were followed up until the end of 12 months. All patients received rupatadine 10 mg/day and were allowed to continue their normal concomitant medication for all conditions, other than rhinitis, for up to 6 or 12 months. Safety was assessed by means of adverse events (AEs) reported by patients or detected by investigators, scheduled centralized ECG with special attention to Bazzet corrected QT interval (QTcB) and standard laboratory investigations. Results: Assessment of treatment compliance rates indicated 90% and 83% of patients to be compliant during the 1–6 months and 1–12 months treatment periods, respectively, with compliance rates >80% being associated with the majority of the study population reporting at least one AE. Overall, 74.1% and 65.8% of the patients reported at least one AE during the 1–6 months and 1–12 months treatment periods, respectively, compared with 20.4% and 10.8% of patients reporting at least one treatment-related AE during these periods. Disorders of the nervous system and respiratory thoracic and media-stinal system, in particular headache, somnolence and catarrh, were the three most common AEs reported by >5% of the patients during both treatment periods. Detailed ECG assessments demonstrated no clinically relevant abnormal ECG findings, nor any QTcB increases >60 msec or QTcB values >470 msec for any patient at any time during treatment. Serious AEs were reported in seven patients, of whom six were considered as unlikely to be related to rupatadine treatment, whereas one involving increased blood enzyme levels was considered as possibly related to rupatadine treatment. Conclusion: This study confirmed the good long-term safety and tolerability of rupatadine at the therapeutic dose of 10 mg/day in patients with PER.

Background Allergic Rhinitis and its Impact on Asthma (ARIA) differentiates mild from moderate/severe patients on the basis of 4 severity items. The high prevalence of moderate/severe patients suggests the need to differentiate between them. Objectives To identify the categorization that maximizes discrimination between moderate and severe allergic rhinitis (AR) by using ARIA guidelines. Methods Observational, cross-sectional study. Clinical characteristics, nasal symptoms (Total Symptom Score 4), and health-related quality of life (HRQL; Rhinoconjunctivitis Quality of Life Questionnaire and Short Form 12) were assessed. The association of severity items (sleep, daily activities/sport, work/school, and troublesome symptoms) with symptoms and HRQL was analyzed using linear regression models. ANOVA and effect sizes were used to assess differences in symptoms and HRQL among groups defined by the number of affected ARIA items. Results Nontreated patients (N = 141) with moderate/severe AR were studied. All severity items showed a similar independent association with symptoms and HRQL scores, and there were no interaction effects, indicating that categorization of patients into moderate and severe could be based only on the number of items affected. Effect sizes were highest between patients with 4 affected ARIA items and those with 3, 2, or 1 affected item (effect sizes greater than 0.8 in all comparisons using Rhinoconjunctivitis Quality of Life Questionnaire and Short Form 12 Physical Composite Summary, and greater than 0.5 using the Total Symptom Score 4; P Conclusion Using ARIA severity items, the criterion that best discriminates AR severity is considering moderate those with 1 to 3 affected items and severe those with 4. Clinical implications Discrimination between patients with moderate and severe AR should help to obtain homogeneous populations for both research and clinical purposes.

Antihistamines are among the most commonly prescribed medicine in pediatrics. According to a Spanish study, 56% of all pediatric patients attending an allergology consultation had received some antihistamine treatment, 22% had received first-generation antihistamines. Of the two million antihistamine units (in solution) sold in Spain in 2006, 34% corresponded to first-generation antihistamines, according to International Medical Statistics (IMS). First-generation antihistamines have never been adequately studied for use in pediatric age groups in terms of efficacy and safety. Nevertheless, they are still used in an apparently high percentage of such patients. The different national and international drugs agencies admit that there are currently many medicines authorized for use in children that have never been adequately investigated for administration in such patients, although they received authorization out of a lack of regulation of the required specification at the time of their commercialization. Their use is still allowed because the pharmacovigilance systems have not detected any adverse event requiring their withdrawal from the market. Many of the antihistamine indications in children have been based on the extrapolation of the effects of these drugs in adults. Worse still, calculation of the pediatric doses has been performed with little or no pharmacokinetic data corresponding to the different pediatric age groups. Currently, the European Medicines Evaluation Agency (EMEA) demands specific pharmacokinetic studies in children over 2 years of age prior to drug authorization, assuming that the efficacy results in adolescents and adults are extrapolable to the pediatric age. For children under 2 years of age, specific efficacy studies are required. In all age groups, the safety data are strictly mandatory, involving 1–3 months of follow-up. These requirements are very different from those that the first-generation antihistamines had to pass. Many of the first-generation antihistamines, with authorization in the Summary of Product Characteristics for pediatric use, are over-thecounter drugs, freely available in the pharmacies, a fact that facilitates their abuse and the potential for adverse events. First-generation antihistamines extensively cross the blood–brain barrier and, therefore, may exert effects on the CNS. Studies demonstrate objective dysfunction upon cognitive processes [1] that can aggravate symptoms due to the disease per se. Furthermore, first-generation antihistamines act upon multiple types of receptor, other than the histamine receptor, unleashing a wide variety of effects, including vision alteration, mucosal membrane dryness, an increase of appetite and bodyweight gain.

ObjectivesTo develop and validate an instrument to measure health-related quality of life (HRQOL) specific to patients with allergic rhinitis (AR) and primarily for use in Spanish and Spanish-speaking populations.MethodsAn initial item pool was generated from literature review, focus groups with AR patients, and consultations with clinical experts. Item reduction was performed using clinimetric and psychometric approaches after administration of the item pool to 400 AR patients. The resulting instrument's internal consistency, test–retest (2–4 weeks) reliability, known groups and convergent validity, and sensitivity to change were tested in a longitudinal, observational, multicenter study in 210 AR patients who also completed the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ).ResultsThe new questionnaire took a mean (SD) of 7.1 (5.4) minutes to answer. Floor and ceiling effects were less than 15% on all dimensions. Cronbach's alpha values and intraclass correlation coefficient values for six of the sevendimensions and the overall score exceeded 0.70. Statistically significant differences (P < 0.01) were observed on all ESPRINT-28 dimensions and the overall score between patients with mild (mean overall score 1.97, SD 0.99), moderate (mean overall score 2.78, SD 0.88), and severe AR (mean overall score 3.89, SD 0.87). Patients with persistent AR had worse scores (P < 0.05) on all dimensions than patients with intermittent AR. Correlations between the ESPRINT-28 and the RQLQ were generally as expected. Effect sizes for score changes between the two study visits ranged from 0.96 to 1.76 for individual dimensions and the overall score.ConclusionsThis new, Spanish-developed instrument to measure HRQOL in AR patients has shown good reliability, validity, and sensitivity to change. It has also proved easy to use and administer.