At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 1-year Multi-center, Prospective, Cohort Study in Patients With Chronic Obstructive Pulmonary Disease Treated With Long-acting Bronchodilator
In Brief
A Phase 4 clinical trial evaluating LABA based treatment: indacaterol, LAMA based treatment: tiotropium, and 4 other interventions for COPD. Completed, enrolled 2,229 participants across 2 sites.
Detailed Summary
This multi-center study is designed to describe natural history of disease, treatment and health care products in physician-diagnosed COPD patients who require adding daily maintenance therapy in real world. The study planned to enroll 550 patients in Indacaterol group and 9450 patients in non- Indacaterol group, a total of 10,000 patients. Enrollment was stopped at 2253 patients due to low recruitment in indacaterol group. Finally a total of 2229 patients were analyzed in full analysis set. A total of 2253 patients entered into the database, of which 24 patients were exclude during the data review meetings, because they did not met the inclusion/exclusion criteria. Hence a total of 2229 patients enrolled successfully.
Study Details
Timeline
Interventions
LABA based treatment: indacaterol
LAMA based treatment: tiotropium
LABA/ICS based treatment: salmeterol/fluticasone
LABA/ICS based treatment: budesonide/formoterol
theophylline based treatment
non-long-acting bronchodilators for COPD treatment, such treatments were classified as "other treatments"