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NCT02867761 · ClinicalTrials.gov registry record · Phase 3
RETHINC: REdefining THerapy In Early COPD for the Pulmonary Trials Cooperative
A Phase 3 study, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 3
- Development phase
- 780
- Enrollment target
NCT02867761: Completed Phase 3 study, sponsored by University of Michigan.
NCT02867761 is a Phase 3 study that has completed, run by University of Michigan. The registered enrollment target is 780 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02867761, a Phase 3 study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 780 participants
- Enrollment target
Study Summary
The study hypothesis is that symptomatic current and former smokers with spirometric values within the normal range (post-bronchodilator FEV1/FVC≥0.70 and post-BD FVC ≥ 70% predicted will still derive symptomatic benefit from long-acting bronchodilator therapy even though they are excluded from current GOLD guideline recommendations.
Primary Outcome
Measured by units of improvement in SGRQ scores at Baseline and 12 weeks, as well as review of treatment failure status at 4 weeks and 12 weeks of treatment (treatment failure is defined by an increase in lower respiratory symptoms necessitating treatment with active, long-acting inhaled bronchodilator, corticosteroids or antibiotics). A 4 unit change is the minimum clinically important difference. SGRQ has a 0 - 100 score; 0 as low symptoms (feeling better) and 100 as high symptoms (feeling wo
Interventions
- DRUG Placebo
- DRUG Indacaterol/Glycopyrrolate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 780 participants |
| Start Date | 2017-08-29 |
| Est. Completion | 2021-07-07 |
| Phase | Phase 3 |
What the finished NCT02867761 record still lists
NCT02867761 is an interventional study that assigns participants to a tested intervention. The registered 780 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02867761 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02867761 about?
NCT02867761 is a clinical study titled "RETHINC: REdefining THerapy In Early COPD for the Pulmonary Trials Cooperative". The study hypothesis is that symptomatic current and former smokers with spirometric values within the normal range (post-bronchodilator FEV1/FVC≥0.70 and post-BD FVC ≥ 70% predicted will still derive symptomatic benefit from long-acting bronchodilator therapy even though they are excluded from curr...
What is the current status of trial NCT02867761?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 780 participants. The study started on 2017-08-29. Estimated completion is 2021-07-07.
What interventions are being tested in trial NCT02867761?
The interventions under investigation include: Placebo (DRUG), Indacaterol/Glycopyrrolate (DRUG).
Who is sponsoring clinical trial NCT02867761?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02867761's enrollment target sits among peer trials
780 434th of 2000 higher than 1,563 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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