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:

Purpose

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).

Patients and 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), %FEV₁ and %FVC, the standardized area under t

SUBMITTER: Yildiz P 

PROVIDER: S-EPMC5125983 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature