Safety, Tolerability and Efficacy of 28-day Inhaled CHF 6001 DPI in COPD Patients

Sponsor
Chiesi Farmaceutici S.p.A.
Study ID
NCT01730404
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • CHF6001 DPI — DRUG
  • Roflumilast — DRUG
  • Placebo — DRUG

Study Details

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.

Key Dates

Start date
Oct 31, 2012
Status verified
Mar 2017
Primary completion
Oct 31, 2013
Completion
Oct 31, 2013

Study Design

Enrollment
55 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: CHF6001
    CHF6001 DPI (Dry Powder Inhaler) once daily
  • Active Comparator: Roflumilast
    Roflumilast, tablet, once daily
  • Placebo Comparator: placebo
    Placebo

Primary Outcome Measure

Adverse events, adverse drug reactions, serious adverse. [ Time Frame: After 28 days of treatment ]

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