Assessment In a Real World Setting of the Effect of Inhaled Steroid-based Triple Therapy Versus the Combination of Tiotropium and Olodaterol on Reducing Chronic Obstructive Pulmonary Disease (COPD) Exacerbations [AIRWISE]

• Status: Completed
• Trial end date: 2020-09-30

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.

• Phase: Phase 4

Details

• Lead Sponsor: Boehringer Ingelheim
• Collaborators: Healthcore; HealthCore-NERI
• Treatments: Cholinergic Agents; Muscarinic Antagonists