Trials / Completed
CompletedNCT03004417
Pharmacodynamics, Pharmacokinetics and Safety of Two Doses of CHF6001 DPI in Subjects With Moderate, Severe COPD
A Randomised, Double-blind,Placebo Controlled, Repeated Dose, Three-way Crossover Study to Evaluate the Pharmacodynamics, Pharmacokinetics and Safety of Two Doses of CHF6001 DPI in Subjects With Moderate, Severe COPD
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 61 (actual)
- Sponsor
- Chiesi Farmaceutici S.p.A. · Industry
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
Summary
Effect of CHF 6001 on biomarkers of inflammation in induced sputum and in blood, on pulmonary function and on symptoms benefits in comparison with placebo.
Detailed description
The purpose of this study is to obtain information on the effects of two doses of CHF6001 on sputum and blood biomarkers of inflammation in subjects with symptomatic COPD with moderate, severe airflow limitation and with chronic bronchitis. The efficacy of the treatment will also be measured using forced oscillometry technique and spirometry. Safety, tolerability and pharmacokinetics will be evaluated.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CHF 6001 Dose1 | CHF 6001 plus placebo |
| DRUG | CHF 6001 Dose2 | CHF 6001 only (high dose) |
| OTHER | Placebo | Placebo only |
Timeline
- Start date
- 2016-10-31
- Primary completion
- 2017-12-28
- Completion
- 2017-12-28
- First posted
- 2016-12-28
- Last updated
- 2020-07-31
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT03004417. Inclusion in this directory is not an endorsement.