At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Pragmatic Clinical Trial in a Community-Based Setting Comparing STIOLTO® RESPIMAT® vs. ICS-LABA Plus LAMA in Patients With COPD
In Brief
A Phase 4 clinical trial evaluating Stiolto Respimat, ICS (Inhaled Corticosteroid) (Triple therapy), and 2 other interventions for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 714 participants across 90 sites.
Detailed Summary
The primary objective of this pragmatic study is to compare the time to first moderate or severe COPD exacerbation in patients, not controlled on their current therapy, randomized to Stiolto Respimat versus triple therapy over 12 months of treatment The secondary objectives of this study include: 1. To compare the annual rate of moderate or severe COPD exacerbations for patients on Stiolto Respimat with patients on triple therapy. 2. To compare the time to first severe COPD exacerbation in both treatment arms. 3. To compare the annual rate of severe COPD exacerbations in both treatment arms. 4. To compare the proportion of patients with moderate or severe COPD exacerbations in both treatment arms.
Study Details
Timeline
Interventions
Duration - 12 months
Duration - 12 months
Duration - 12 months
Duration - 12 months