This trial is completed!
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You can access this
clinical trial
if you have
COPD
and you are
between 40 and 70
years old
Phase
2
This is a second phase trial assessing
efficacy and side effects of the new treatment.
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The purpose

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.

Provided treatments

  • Drug: CHF6001 DPI
  • Drug: Roflumilast
  • Drug: Placebo
Tris trial is registered with FDA with number: NCT01730404. The sponsor of the trial is Chiesi Farmaceutici S.p.A. and it is looking for 55 volunteers for the current phase.
Official trial title:
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