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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 is a Phase 2 study that has completed, run by Sunovion Respiratory Development. The registered enrollment target is 140 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01426009
The ClinicalTrials.gov registry entry for NCT01426009 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sunovion Respiratory Development, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which EP-101 via nebulizer (eFlow®) 25 ug is the first listed.
NCT01426009 reports 0 study locations.
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.
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