Tiotropium improves lung function, exacerbation rate, and asthma control, independent of baseline characteristics including age, degree of airway obstruction, and allergic status. (August 2016)

• Record Type: Journal Article
• Authors: Kerstjens, Huib A.M.; Moroni-Zentgraf, Petra; Tashkin, Donald P.; Dahl, Ronald; Paggiaro, Pierluigi; Vandewalker, Mark; Schmidt, Hendrik; Engel, Michael; Bateman, Eric D.
• Is Part Of: Respiratory medicine. Volume 117(2016)
• Page Start: 198
• Page End: 206
• Publication Date: 2016-08
• Subjects: Asthma worsening -- FEV1 -- Respimat® -- Exacerbation -- Tiotropium -- Symptom control; ACQ-7 seven-question Asthma Control Questionnaire -- AQLQ Asthma Quality of Life Questionnaire -- CI confidence interval -- FEV1 forced expiratory volume in 1 s -- FVC forced vital capacity -- HR hazard ratio -- ICS inhaled corticosteroids -- IgE immunoglobulin E -- LABA long-acting β2-agonist -- LTRA leukotriene receptor antagonist -- NC not calculated -- OR odds ratio -- peak FEV1(0–3h) peak forced expiratory volume in 1 s within 3 h after the administration of maintenance therapy and study drug -- SD standard deviation -- TALC Tiotropium Bromide as an Alternative to Increased Inhaled Glucocorticoid in Patients Inadequately Controlled on a Lower Dose of Inhaled Corticosteroid; Chest -- Diseases -- Periodicals; Chest -- Diseases -- Great Britain -- Periodicals; Respiratory organs -- Diseases -- Periodicals; Respiratory Tract Diseases -- Periodicals; Appareil respiratoire -- Maladies -- Périodiques; Thorax -- Maladies -- Périodiques; Appareil respiratoire -- Maladies -- Traitement -- Périodiques; Electronic journals; 616.2
• DOI: 10.1016/j.rmed.2016.06.013
• Languages: English
• ISSNs: 0954-6111

Abstract

Abstract: Background: Many patients with asthma remain symptomatic despite treatment with inhaled corticosteroids (ICS) with or without long-acting β2 -agonists (LABAs). Tiotropium add-on to ICS plus a LABA has been shown to improve lung function and reduce exacerbation risk in patients with symptomatic asthma. Objective: To determine whether the efficacy of tiotropium add-on therapy is dependent on patients' baseline characteristics. Methods: Two randomized, double-blind, parallel-group, twin trials (NCT00772538 and NCT00776984) of once-daily tiotropium Respimat ® 5 μg add-on to ICS plus a LABA were performed in parallel in patients with severe symptomatic asthma. Exploratory subgroup analyses of peak forced expiratory volume in 1 s (FEV1 ), trough FEV1, time to first severe exacerbation, time to first episode of asthma worsening, and seven-question Asthma Control Questionnaire responder rate were performed to determine whether results were influenced by baseline characteristics. Results: 912 patients were randomized: 456 received tiotropium and 456 received placebo. Tiotropium improved lung function, reduced the risk of asthma exacerbations and asthma worsening, and improved asthma symptom control, compared with placebo, independent of baseline characteristics including gender, age, body mass index, disease duration, age at asthma onset, and FEV1 % predicted at screening and reversibility. Conclusion: Once-daily tiotropium 5 μg compared with placebo improved lung function, reduced the risk of asthma exacerbations and asthma worsening, and improved asthma symptom control, independent of a broad range of baseline characteristics, as add-on to ICS plus LABAs in patients with severe symptomatic asthma. Trial registry: ClinicalTrials.gov; numbers NCT00772538 and NCT00776984 URL: www.clinicaltrials.gov. Highlights: Tiotropium improves lung function, independent of baseline characteristics. Tiotropium reduces asthma exacerbation risk, independent of baseline characteristics. Tiotropium improves asthma symptom control, independent of baseline characteristics. Tiotropium provides a beneficial treatment option, regardless of baseline features.