Trials / Completed
CompletedNCT00640484
Confirmatory Dose Finding Study of 2 Dosages of CHF 4226 pMDI (Carmoterol) in Patients With COPD
Evaluation of the Effect of 2 Weeks Treatment With CHF 4226 pMDI 2µg and 4µg, Given Once Daily in the Morning, on 24-Hour FEV1 in Patients With COPD
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 57 (actual)
- Sponsor
- Chiesi Farmaceutici S.p.A. · Industry
- Sex
- All
- Age
- 40 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to confirm the dose of CHF 4226 (carmoterol) that should be given once a day to patients with COPD in order for the effect to last for 24 hours.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | carmoterol (CHF 4226) | carmoterol (CHF 4226) 2 μg once a day, in the morning (1 puff of carmoterol 2 μg + 1 puff of placebo pMDI) |
| DRUG | carmoterol (CHF 4226) | carmoterol (CHF 4226) 4 μg once a day, in the morning (1 puff of carmoterol 2 µg + 1 puff of carmoterol 2µg) |
| DRUG | placebo | placebo once a day, in the morning (1 puff of placebo pMDI + 1 puff of placebo pMDI) |
| DRUG | salmeterol | Salmeterol 50 μg twice daily, in the morning and in the evening (1 blister of Serevent Diskus BID) |
Timeline
- Start date
- 2008-04-01
- Primary completion
- 2008-10-01
- Completion
- 2008-10-01
- First posted
- 2008-03-21
- Last updated
- 2010-08-27
Locations
15 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00640484. Inclusion in this directory is not an endorsement.