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Background: Inhalation therapy is the cornerstone of treatment of bronchial asthma. A patient-specific selection of inhalation devices is necessary, as preference for a device plays an important role in terms of error rates in handling and adherence to therapy. However, there is no industry-independent study providing information on children's preferences for common inhaler types. The aim of the present study was to investigate the preference of asthmatic children for inhaler types commonly used in Germany. The effects of age, gender and the type of school visited on device preferences as well as the frequency of patient education and the role of health care providers in the choice for an inhaler were investigated. Methods: Eighty children were included in this prospective cross-sectional study (age: 10.87 ± 2.62 years). The analysis was based on a questionnaire and validated checklists. All participants tested the use of nine placebo inhalers (Breezhaler, Diskus, Respimat, Spiromax, Turbohaler, Autohaler, metered-dose inhaler, Easyhaler and Novolizer) in a randomized order. For each device, patients were asked to assess handling, rate different device characteristics and name the device they would prefer most or least. Results: The most favored device was the Novolizer. Moreover, the Spiromax scored highest in numerous categories such as suitability in emergencies and "easiest" device to use. Patient preferences with respect to the addressed inhaler features were not significantly related to age, gender or school type. Conclusion: The Novolizer and the Spiromax showed higher preference in pediatric patients as compared to other tested devices. Overall, there were significant differences in terms of preference when comparing the tested inhalers in different aspects. [ABSTRACT FROM AUTHOR]

This epidemiological study aimed to compare the caries and molar incisor hypomineralisation (MIH) experience in asthmatic and non-asthmatic adolescents assessed at 10 and 15 years of age. 730 adolescents from ongoing birth cohort studies (GINIplus/LISA) from Munich, Germany, were examined for carious lesions at the age of 10 and 15 years to determine caries experience under inclusion of non-cavitated carious lesions D1-2T and the tooth-related decay-missing-filled index. Furthermore, MIH was scored on all permanent teeth according to the criteria of the European Academy of Paediatric Dentistry. The association between caries and MIH prevalence at the 10-year and 15-year follow-up as well as caries incidence with ever having an asthma diagnosis was analysed using hurdle regression models adjusted for potential confounders. Of the 730 adolescents, 52 and 78 were identified as asthmatics at the 10- and 15-year follow-up, respectively. There were no significant differences in caries prevalence or experience between asthma-free participants and any of the asthma groups (taking metered-dose inhaler (MDI) medication vs. taking no MDI medication). However, a significant positive association was found for asthmatic adolescents who did not take MDI medication with higher MIH/T values (OR = 2.56, 95% CI = 1.03-6.37, p = 0.043) compared to non-asthmatics. In conclusion, asthma did not influence the caries status of adolescents in the present study. Interestingly, a significant association was found between adolescents with asthma who did not take MDI medication and the number of MIH-affected teeth. The association between asthma, medication, and MIH needs further confirmation. [ABSTRACT FROM AUTHOR]

Objectives: In Germany, population-wide data on adherence to national asthma management guidelines are lacking, and performance measures (PM) for quality assurance in asthma care are systematically monitored for patients with German national asthma disease management program (DMP) enrollment only. We used national health survey data to assess variation in asthma care PM with respect to patient characteristics and care context, including DMP enrollment.Methods: Among adults 18–79 years with self-reported physician-diagnosed asthma in the past 12 months identified from a recent German National Health Interview Survey (GEDA 2010:N = 1096) and the German National Health interview and Examination Survey 2008–2011 (DEGS1:N = 333), variation in asthma care PM was analyzed using logistic regression analysis.Results: Overall, 38.4% (95% confidence interval: 32.5–44.6%) of adults with asthma were on current inhaled corticosteroid therapy. Regarding non-drug asthma management, low coverage was observed for inhaler technique monitoring (35.2%; 31.2–39.3%) and for provision of an asthma management plan (27.3%; 24.2–30.7%), particularly among those with low education. Specific PM were more complete among persons with than without asthma DMP enrollment (adjusted odds ratios ranging up to 10.19; 5.23–19.86), even if asthma patients were regularly followed in a different care context.Conclusions: Guideline adherence appears to be suboptimal, particularly with respect to PM related to patient counseling. Barriers to the translation of recommendations into practice need to be identified and continuous monitoring of asthma care PM at the population level needs to be established. [ABSTRACT FROM AUTHOR]

This study assessed preference and ease of use of the Diskus® and the Handihaler® in symptomatic chronic obstructive pulmonary disease (COPD) patients. No patient had used either device before. Patients were given a questionnaire to assess the inhalers and to rank the most important feature of an inhaler. Patients in Germany (n = 125) and the Netherlands (n = 131) with a mean age of 60 participated.Fifty-eight percent of German patients and 69% of Dutch patients had no problems using the Diskus compared to only 11 and 32%, respectively, using the Handihaler (p < 0.001). Overall, 79% of patients would be happy to use the Diskus and 46% the Handihaler if their physician suggested it. However, 35% of Dutch patients and 72% of German patients stated they would not be happy to use the Handihaler.The Diskus was rated higher than the Handihaler for the top three features of an ideal inhaler. Overall the Diskus inhaler was preferred by 67% of patients. [ABSTRACT FROM AUTHOR]

Introduction: An extrafine formulation of the long-acting muscarinic antagonist, glycopyrronium bromide (GB), has been developed for delivery via the NEXThaler dry powder inhaler (DPI). This study assessed the bronchodilator efficacy and safety of different doses of this formulation in patients with COPD to identify the optimal dose for further development., Patients and Methods: This was a multicenter, randomized, double-blind, placebo-controlled, incomplete block, three-way crossover study, including three 28-day treatment periods, each separated by a 21-day washout period. Eligible patients had a diagnosis of COPD and post-bronchodilator forced expiratory volume in 1 s (FEV 1 ) 40%-70% predicted. Treatments administered were GB 6.25, 12.5, 25 and 50 μg or matched placebo; all were given twice daily (BID) via DPI, with spirometry assessed on Days 1 and 28 of each treatment period. The primary end point was FEV 1 area under the curve from 0 to 12 h (AUC 0-12 h ) on Day 28., Results: A total of 202 patients were randomized (61% male, mean age 62.6 years), with 178 (88%) completing all the three treatment periods. For the primary end point, all the four GB doses were superior to placebo ( p <0.001) with mean differences (95% CI) of 114 (74, 154), 125 (85, 166), 143 (104, 183) and 187 (147, 228) mL for GB 6.25, 12.5, 25 and 50 μg BID, respectively. All four GB doses were also statistically superior to placebo for all secondary efficacy end points, showing clear dose-response relationships for most of the endpoints. Accordingly, GB 25 μg BID met the criteria for the minimally acceptable dose. Adverse events were reported by 15.5, 16.2, 10.9 and 14.3% of patients receiving GB 6.25, 12.5, 25 and 50 μg BID, respectively, and 14.8% receiving placebo., Conclusion: This study supports the selection of GB 25 μg BID as the minimal effective dose for patients with COPD when delivered with this extrafine DPI formulation., Competing Interests: Disclosure KMB declares that no personal payments were received from any pharmaceutical entity in the past 5 years. KMB is a full-time employee of Insaf Respiratory Research Institute. The institution has received compensation for services on advisory boards or consulting for Ablynx, Almirall, AstraZeneca, Berlin Chemie, Boehringer, Chiesi, Cytos, Mundipharma, Novartis, Pohl Boskamp and Zentiva. The institution has received compensation for speaker activities in scientific meetings supported by Almirall, AstraZeneca, Berlin Chemie, Boehringer, Cytos, ERT, GSK, Novartis, Pfizer, Pohl Boskamp and Takeda. The institution has further received compensation for design and performance of clinical trials from Almirall, Altana/Nycomed, AstraZeneca, Boehringer, Cytos, GSK, Infinity, Medapharma, MSD, Mundipharma, Novartis, Parexel, Pearl Therapeutics, Pfizer, Revotar, Teva, Sterna, and Zentiva. AE, HP, DS and MAN are employees of Chiesi, the study sponsor. The authors report no other conflicts of interest in this work.