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NCT03265145 · ClinicalTrials.gov registry record · Phase 4
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]
A Phase 4 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 4
- Development phase
- 714
- Enrollment target
NCT03265145: Completed Phase 4 study, sponsored by Boehringer Ingelheim.
NCT03265145 is a Phase 4 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 714 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (38% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03265145, a Phase 4 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 714 participants
- Enrollment target
Study 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.
Primary Outcome
Time to first moderate or severe chronic obstructive (COPD) exacerbation over 12 months of treatment pulmonary disease. Moderate exacerbation was a patient receiving an exacerbation-related prescription such as oral corticosteroid (prednisone or prednisolone) and/or antibiotic, but not requiring hospitalization. Severe exacerbation was a patient requiring hospitalization or emergency room visit due to COPD (ICD-9-491.21 or ICD-10-J44.1). Median survival time as well as 95% confidence interval
Interventions
- DRUG Stiolto Respimat
- DRUG ICS (Inhaled Corticosteroid) (Triple therapy)
- DRUG LABA (Long-Acting Beta Agonist) (Triple therapy)
- DRUG LAMA (Long-Acting Muscarinic Antagonist) (Triple therapy)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 714 participants |
| Start Date | 2017-09-20 |
| Est. Completion | 2020-09-30 |
| Phase | Phase 4 |
What the finished NCT03265145 record still lists
NCT03265145 is an interventional study that assigns participants to a tested intervention. The registered 714 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (38% higher).
The record links to 0 conditions, and to 4 interventions - of which Stiolto Respimat is the first listed.
NCT03265145 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03265145 about?
NCT03265145 is a clinical study titled "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]". 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: ...
What is the current status of trial NCT03265145?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 714 participants. The study started on 2017-09-20. Estimated completion is 2020-09-30.
What interventions are being tested in trial NCT03265145?
The interventions under investigation include: Stiolto Respimat (DRUG), ICS (Inhaled Corticosteroid) (Triple therapy) (DRUG), LABA (Long-Acting Beta Agonist) (Triple therapy) (DRUG), LAMA (Long-Acting Muscarinic Antagonist) (Triple therapy) (DRUG).
Who is sponsoring clinical trial NCT03265145?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03265145's enrollment target sits among peer trials
714 114th of 2000 higher than 1,887 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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