Trials / Completed
CompletedNCT01488019
Study to Evaluate the Safety of Long-Term Use of Perforomist® (Formoterol Fumarate)
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety of Long-Term Use of Perforomist® (Formoterol Fumarate) Inhalation Solution in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 1,071 (actual)
- Sponsor
- Dey · Industry
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
Summary
This study is a multi-center, randomized, placebo-controlled study to evaluate the long-term safety of Perforomist® inhalation therapy in subjects with Chronic Obstructive Pulmonary Disease (COPD). Individual participation is approximately 54 weeks, including 52 weeks of double-blind treatment.
Detailed description
None provided.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Perforomist-Placebo | Placebo vehicle, 2mL, twice daily for 52 weeks |
| DRUG | Perforomist, nebulization, COPD | Perforomist, 20 mcg/2 mL, twice daily for 52 weeks |
Timeline
- Start date
- 2012-03-01
- Primary completion
- 2016-01-01
- Completion
- 2016-01-01
- First posted
- 2011-12-08
- Last updated
- 2017-06-12
- Results posted
- 2017-06-12
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01488019. Inclusion in this directory is not an endorsement.