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NCT02347761 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Trial of 12 Weeks of Treatment With Nebulized SUN-101 in Patients With COPD
A Phase 3 study, sponsored by Sunovion Respiratory Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 653
- Enrollment target
NCT02347761: Completed Phase 3 study, sponsored by Sunovion Respiratory Development.
NCT02347761 is a Phase 3 study that has completed, run by Sunovion Respiratory Development. The registered enrollment target is 653 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02347761, a Phase 3 study, has completed, sponsored by Sunovion Respiratory Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 653 participants
- Enrollment target
Study Summary
This is a trial of 12 weeks of treatment with nebulized SUN-101 using an Investigational eFlow® Closed System (CS) nebulizer in subjects with chronic obstructive pulmonary disease (COPD) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD 2014) guidelines.
Primary Outcome
ALL COLLECTED-Spirometry was performed according to internationally accepted standards.Trough FEV1 at Week 12 was defined as the mean of the values collected at two time points 30 minutes apart at approximately 24 hours (± 1 hour) after the previous morning dose.Change from baseline in trough FEV1 was calculated as the trough FEV1 value at Week 12 minus the morning trough FEV1 at baseline (mean of the two pre-dose values at 45 and 15 minutes prior to the first dose). All collected values were us
Interventions
- DRUG SUN-101 50 mcg BID eFlow (CS) nebulizer
- DRUG SUN-101 25 mcg BID eFlow (CS) nebulizer
- DRUG Placebo BID eFlow Closed System (CS) nebulizer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 653 participants |
| Start Date | 2015-02 |
| Est. Completion | 2015-11 |
| Phase | Phase 3 |
What the finished NCT02347761 record still lists
NCT02347761 is an interventional study that assigns participants to a tested intervention. The registered 653 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (15% lower).
The record links to 0 conditions, and to 3 interventions - of which SUN-101 50 mcg BID eFlow (CS) nebulizer is the first listed.
NCT02347761 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02347761 about?
NCT02347761 is a clinical study titled "Efficacy and Safety Trial of 12 Weeks of Treatment With Nebulized SUN-101 in Patients With COPD". This is a trial of 12 weeks of treatment with nebulized SUN-101 using an Investigational eFlow® Closed System (CS) nebulizer in subjects with chronic obstructive pulmonary disease (COPD) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD 2014) guidelines.
What is the current status of trial NCT02347761?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 653 participants. The study started on 2015-02. Estimated completion is 2015-11.
What interventions are being tested in trial NCT02347761?
The interventions under investigation include: SUN-101 50 mcg BID eFlow (CS) nebulizer (DRUG), SUN-101 25 mcg BID eFlow (CS) nebulizer (DRUG), Placebo BID eFlow Closed System (CS) nebulizer (DRUG).
Who is sponsoring clinical trial NCT02347761?
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 NCT02347761's enrollment target sits among peer trials
653 571st of 2000 higher than 1,430 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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