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NCT01426009 · ClinicalTrials.gov registry record · Phase 2
Study to Investigate the Dose Response, Safety and Efficacy of Nebulized EP-101(SUN101) in Patients With Chronic Obstructive Pulmonary Disease (COPD): GOLDEN-1 Study
A Phase 2 study, sponsored by Sunovion Respiratory Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 140
- Enrollment target
NCT01426009: Completed Phase 2 study, sponsored by Sunovion Respiratory Development.
NCT01426009 is a Phase 2 study that has completed, run by Sunovion Respiratory Development. The registered enrollment target is 140 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01426009, a Phase 2 study, has completed, sponsored by Sunovion Respiratory Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 140 participants
- Enrollment target
Study Summary
The purpose of this study is to determine steady-state efficacy and dose response profile and to assess safety and pharmacokinetic profile of nebulized EP-101(SUN101) after 7-day dosing using an investigational high efficiency nebulizer (eFlow®) compared with placebo and two active comparators in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).
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 post dose for Day 1 and Day 7 within each Treatment Period. Baseline was calculated as the mean of the FEV1 values at 45 minutes and 15 minutes prior to the morning dose at Day 1 of each Treatment Period. Change from baseline was calculated as the trough FEV1 value minus the baseline for Day 1 and
Interventions
- DRUG EP-101 via nebulizer (eFlow®) 25 ug
- DRUG EP-101 via nebulizer (eFlow®) 50 ug
- DRUG EP-101 via nebulizer (eFlow®) 100 ug
- DRUG Placebo EP-101
- DRUG Tiotropium bromide via (Spiriva® Handihaler®)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2011-08 |
| Est. Completion | 2011-12 |
| Phase | Phase 2 |
What the finished NCT01426009 record still lists
NCT01426009 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which EP-101 via nebulizer (eFlow®) 25 ug is the first listed.
NCT01426009 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01426009 about?
NCT01426009 is a clinical study titled "Study to Investigate the Dose Response, Safety and Efficacy of Nebulized EP-101(SUN101) in Patients With Chronic Obstructive Pulmonary Disease (COPD): GOLDEN-1 Study". The purpose of this study is to determine steady-state efficacy and dose response profile and to assess safety and pharmacokinetic profile of nebulized EP-101(SUN101) after 7-day dosing using an investigational high efficiency nebulizer (eFlow®) compared with placebo and two active comparators in pa...
What is the current status of trial NCT01426009?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 140 participants. The study started on 2011-08. Estimated completion is 2011-12.
What interventions are being tested in trial NCT01426009?
The interventions under investigation include: EP-101 via nebulizer (eFlow®) 25 ug (DRUG), EP-101 via nebulizer (eFlow®) 50 ug (DRUG), EP-101 via nebulizer (eFlow®) 100 ug (DRUG), Placebo EP-101 (DRUG), Tiotropium bromide via (Spiriva® Handihaler®) (DRUG).
Who is sponsoring clinical trial NCT01426009?
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 NCT01426009's enrollment target sits among peer trials
140 512th of 2000 higher than 1,476 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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