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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 is a Phase 4 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 714 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03265145
The ClinicalTrials.gov registry entry for NCT03265145 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 714 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Stiolto Respimat is the first listed.
NCT03265145 reports 0 study locations.
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.
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