NCT03265145

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]

Randomized Pragmatic Clinical Trial in a Community-Based Setting Comparing STIOLTO® RESPIMAT® vs. ICS-LABA Plus LAMA in Patients With COPD

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 714 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

Type	Name	Description
DRUG	Stiolto Respimat	Duration - 12 months
DRUG	ICS (Inhaled Corticosteroid) (Triple therapy)	Duration - 12 months
DRUG	LABA (Long-Acting Beta Agonist) (Triple therapy)	Duration - 12 months
DRUG	LAMA (Long-Acting Muscarinic Antagonist) (Triple therapy)	Duration - 12 months

Timeline

• Start date: 2017-09-20
• Primary completion: 2020-09-30
• Completion: 2020-09-30
• First posted: 2017-08-29
• Last updated: 2022-06-14
• Results posted: 2021-12-09

Locations

90 sites across 1 country: United States

Regulatory

• FDA-regulated drug study