Trials / Completed
CompletedNCT01730404
Safety, Tolerability and Efficacy of 28-day Inhaled CHF 6001 DPI in COPD Patients
A Randomised, Double-blind, Double-dummy, Placebo and Active-controlled, Three-way Crossover Study to Evaluate the Safety, Tolerability and Efficacy of 28-day Inhaled CHF 6001 DPI (1200 µg Daily) in Subjects With COPD
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 55 (actual)
- Sponsor
- Chiesi Farmaceutici S.p.A. · Industry
- Sex
- All
- Age
- 40 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
Phase IIa study in COPD patients aimed to evaluate the safety, tolerability ,pharmacodynamics (effect on biological markers of inflammation in induced sputum and in blood, and on pulmonary function) and on pharmacokinetics of CHF 6001 (a PDE4 inhibitor) after 28-days of daily inhaled dosing.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CHF6001 DPI | |
| DRUG | Roflumilast | |
| DRUG | Placebo |
Timeline
- Start date
- 2012-10-01
- Primary completion
- 2013-10-01
- Completion
- 2013-10-01
- First posted
- 2012-11-21
- Last updated
- 2017-03-29
Locations
5 sites across 2 countries: Ireland, United Kingdom
Source: ClinicalTrials.gov record NCT01730404. Inclusion in this directory is not an endorsement.