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NCT01706536 · ClinicalTrials.gov registry record · Phase 2
A Study of the Efficacy and Safety of EP-101 ( (SUN101) in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease
A Phase 2 study, sponsored by Sunovion Respiratory Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 275
- Enrollment target
NCT01706536: Completed Phase 2 study, sponsored by Sunovion Respiratory Development.
NCT01706536 is a Phase 2 study that has completed, run by Sunovion Respiratory Development. The registered enrollment target is 275 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (107% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01706536, a Phase 2 study, has completed, sponsored by Sunovion Respiratory Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 275 participants
- Enrollment target
Study Summary
This is a randomized, double-blind, placebo-controlled, parallel arm study. The study population will consist of subjects, 35 to 75 years of age, with a diagnosis of moderate to severe COPD per Global Initiative for Chronic Obstructive Lung Disease guidelines.
Primary Outcome
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. Trough FEV1 was defined as the mean of the spirometry values collected at 23 hours 30 minutes and 24 hours after the in-clinic morning dose (i.e. approximately 12 hrs after the previous evening dose).
Interventions
- DRUG Placebo
- DRUG EP-101 12.5 mcg
- DRUG EP-101 25 mcg
- DRUG EP-101 50 mcg
- DRUG EP-101 100 mcg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 275 participants |
| Start Date | 2012-10 |
| Est. Completion | 2013-04 |
| Phase | Phase 2 |
What the finished NCT01706536 record still lists
NCT01706536 is an interventional study that assigns participants to a tested intervention. The registered 275 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (107% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT01706536 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01706536 about?
NCT01706536 is a clinical study titled "A Study of the Efficacy and Safety of EP-101 ( (SUN101) in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease". This is a randomized, double-blind, placebo-controlled, parallel arm study. The study population will consist of subjects, 35 to 75 years of age, with a diagnosis of moderate to severe COPD per Global Initiative for Chronic Obstructive Lung Disease guidelines.
What is the current status of trial NCT01706536?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 275 participants. The study started on 2012-10. Estimated completion is 2013-04.
What interventions are being tested in trial NCT01706536?
The interventions under investigation include: Placebo (DRUG), EP-101 12.5 mcg (DRUG), EP-101 25 mcg (DRUG), EP-101 50 mcg (DRUG), EP-101 100 mcg (DRUG).
Who is sponsoring clinical trial NCT01706536?
This trial is sponsored by Sunovion Respiratory Development, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01706536's enrollment target sits among peer trials
275 203rd of 2000 higher than 1,798 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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