title: Tiotropium improves lung function, exacerbation rate, and asthma control, independent of baseline characteristics including age, degree of airway obstruction, and allergic status.
abstract: 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.
  
  
  
  To determine whether the efficacy of tiotropium add-on therapy is dependent on patients' baseline characteristics.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  ClinicalTrials.gov; numbers NCT00772538 and NCT00776984 URL: www.clinicaltrials.gov.
authors: University of Groningen, Department of Pulmonary Medicine, Groningen Research Institute for Asthma and COPD, University Medical Center Groningen, Postbox 30.001, 9700 RB Groningen, The Netherlands. Electronic address: h.a.m.kerstjens@umcg.nl.
authors: Huib A M
authors: HA
authors: Kerstjens
authors: TA Respiratory Diseases, Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Straße 173, 55216 Ingelheim am Rhein, Germany. Electronic address: petra.moroni-zentgraf@boehringer-ingelheim.com.
authors: Petra
authors: P
authors: Moroni-Zentgraf
authors: Division of Pulmonary and Critical Care Medicine, David Geffen School of Medicine at UCLA, 37-131 Center for Health Sciences, 10833 Le Conte Avenue, Los Angeles, CA 90095-1690, USA. Electronic address: DTashkin@mednet.ucla.edu.
authors: Donald P
authors: DP
authors: Tashkin
authors: Odense University Hospital, University of Southern Denmark, Sdr Boulevard, DK 5000 Odense C, Denmark. Electronic address: Ronald.Dahl2@rsyd.dk.
authors: Ronald
authors: R
authors: Dahl
authors: Dipartimento Cardio-Toracico e Vascolare, SD Fisiopatologia e Riabilitazione Respiratoria, AOUP, via Paradisa 2, 56124 Pisa, Italy. Electronic address: pierluigi.paggiaro@unipi.it.
authors: Pierluigi
authors: P
authors: Paggiaro
authors: Clinical Research of the Ozarks, 601 W Nifong Blvd, Suite 2A, Columbia, MO 65203, USA. Electronic address: drmlvand@aol.com.
authors: Mark
authors: M
authors: Vandewalker
authors: Global Biometrics and Data Sciences, Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Straße 65, 88400 Biberach an der Riss, Germany. Electronic address: hendrik.schmidt@boehringer-ingelheim.com.
authors: Hendrik
authors: H
authors: Schmidt
authors: TA Respiratory Diseases, Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Straße 173, 55216 Ingelheim am Rhein, Germany. Electronic address: michael.engel@boehringer-ingelheim.com.
authors: Michael
authors: M
authors: Engel
authors: Department of Medicine, University of Cape Town, Mowbray 7700, Cape Town, South Africa. Electronic address: eric.bateman@uct.ac.za.
authors: Eric D
authors: ED
authors: Bateman
mesh_terms: D000280:Administration, Inhalation; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage / Q000627:therapeutic use; D058666:Adrenergic beta-2 Receptor Agonists / Q000008:administration & dosage / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D000402:Airway Obstruction / Q000145:classification / Q000188:drug therapy; D001249:Asthma / Q000188:drug therapy* / Q000517:prevention & control; D001993:Bronchodilator Agents / Q000627:therapeutic use; D018450:Disease Progression; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects*; D006801:Humans; D006967:Hypersensitivity / Q000145:classification / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D012720:Severity of Illness Index; D012907:Smoking / Q000453:epidemiology; D000069447:Tiotropium Bromide / Q000008:administration & dosage / Q000494:pharmacology*
chemical_list: D000305:Adrenal Cortex Hormones; D058666:Adrenergic beta-2 Receptor Agonists; D001993:Bronchodilator Agents; D000069447:Tiotropium Bromide
keywords: Asthma worsening; Exacerbation; FEV(1); Respimat(®); Symptom control; Tiotropium