title: Bronchodilator efficacy of 18 μg once-daily tiotropium inhalation via Discair®versus HandiHaler®in adults with chronic obstructive pulmonary disease: randomized, active-controlled, parallel-group, open-label, Phase IV trial.
abstract: OBJECTIVE
  To compare the bronchodilator efficacy of 18 μg once-daily tiotropium inhalation administered via Discair®versus HandiHaler®in adults with moderate-to-severe chronic obstructive pulmonary disease (COPD).
  
  
  METHODS
  Fifty-eight patients with moderate-to-severe COPD were enrolled in this randomized, active-controlled, parallel-group, open-label, Phase IV non-inferiority trial. Patients were randomly assigned to a test group (n=29, inhalation with Discair) or a reference group (n=29, inhalation with HandiHaler). The primary efficacy parameter was the average maximum change in forced expiratory volume in 1 second (FEV1, in L). Change in forced vital capacity (FVC, in L), %FEV1and %FVC, the standardized area under the response-time curve (AUC) for the absolute change in FEV1and FVC, time to onset and peak of response, and safety data were also evaluated.
  
  
  RESULTS
  The test inhaler was non-inferior to the reference inhaler in terms of maximum change in FEV1at 24 h (unadjusted change: 0.0017 L [95% confidence interval [CI]: -0.0777, 0.0812]; change adjusted for time to reach maximum change in FEV1and smoking in pack-years: 0.0116 L [95% CI: -0.0699, 0.0931]), based on a non-inferiority margin of 0.100 L. There were also no significant differences between the two groups in maximum change in FVC value from baseline (0.3417 L vs 0.4438 L,P=0.113), percent change from baseline (22.235 vs 20.783 for FEV1,P=0.662; 16.719 vs 20.337 for FVC,P=0.257), and AUC0-24 h(2.949 vs 2.833 L for FEV1,P=0.891; 2.897 vs 4.729 L for FVC,P=0.178). There were no adverse events, serious adverse events, or deaths.
  
  
  CONCLUSIONS
  Our findings show that the Discair was non-inferior to the HandiHaler. More specifically, these devices had similar clinical efficacy in terms of time-dependent response over 24 h for patients with moderate-to-severe COPD.
authors.affiliation: Clinics of Chest Diseases, Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital, Istanbul, Turkey.
authors.forename: Pinar
authors.initials: P
authors.lastname: Yildiz
authors.affiliation: Clinics of Chest Diseases, Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital, Istanbul, Turkey.
authors.forename: Mesut
authors.initials: M
authors.lastname: Bayraktaroglu
authors.affiliation: Clinics of Chest Diseases, Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital, Istanbul, Turkey.
authors.forename: Didem
authors.initials: D
authors.lastname: Gorgun
authors.affiliation: Clinics of Chest Diseases, Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital, Istanbul, Turkey.
authors.forename: Funda
authors.initials: F
authors.lastname: Secik
mesh_terms: D000280:Administration, Inhalation; D000368:Aged; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects; D018680:Cholinergic Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D058995:Dry Powder Inhalers; D004867:Equipment Design; D005260:Female; D005541:Forced Expiratory Volume; D006801:Humans; D008168:Lung / Q000187:drug effects* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D012720:Severity of Illness Index; D013997:Time Factors; D000069447:Tiotropium Bromide / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D014421:Turkey; D014797:Vital Capacity
chemical_list: D001993:Bronchodilator Agents; D018680:Cholinergic Antagonists; D000069447:Tiotropium Bromide
keywords: Discair®; HandiHaler®; bronchodilator efficacy; non-inferiority; spirometry; tiotropium