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
Overview
- Phase
- Phase 2
- Intervention
- CHF6001 DPI
- Conditions
- COPD
- Sponsor
- Chiesi Farmaceutici S.p.A.
- Enrollment
- 55
- Locations
- 5
- Primary Endpoint
- Adverse events, adverse drug reactions, serious adverse.
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Written informed consent obtained prior to any study-related procedures.
- •Male or female aged between 40 and 70 years inclusive.
- •Current or past smoker of at least 10 pack/years
- •BMI in the range of 18-35 Kg/m2
- •GOLD Stage 2 and 3 COPD subjects
- •A history of chronic bronchitis defined as chronic cough and sputum production
- •At screening, subjects must be able to produce an adequate induced sputum sample
- •Female subjects: post-menopausal women having at least 12 months of natural (spontaneous) amenorrhea, or women of childbearing potential using two acceptable methods of contraception for the duration of the study and for the following three months
- •Exclusion criteria:
- •Female subjects: pregnant or lactating women
Exclusion Criteria
- Not provided
Arms & Interventions
CHF6001
CHF6001 DPI (Dry Powder Inhaler) once daily
Intervention: CHF6001 DPI
Roflumilast
Roflumilast, tablet, once daily
Intervention: Roflumilast
placebo
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Adverse events, adverse drug reactions, serious adverse.
Time Frame: After 28 days of treatment
The number and percentage of subjects experiencing AEs, ADRs, serious AEs and AEs leading to study withdrawal.
Vital signs
Time Frame: After 28 days of treatment
12-lead ECG parameters
Time Frame: After 28 days of treatment
Secondary Outcomes
- Pharmacokinetics of CHF 6001 and its metabolites(After 28 days of treatment)
- Induction of sputum(After 28 days of treatment)
- Baseline Dyspnea Index and Transition Dyspnea Index Questionnaire(After 28 days of treatment)
- Lung function measurements(After 28 days of treatment)