Evaluation of safety, tolerability & efficacy of 28day inhaled CHF6001
Research type
Research Study
Full 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 (1200microgrammes daily) in subjects with COPD
IRAS ID
107865
Contact name
S D Singh
Contact email
Sponsor organisation
Chiesi Farmaceutici S.p.A.
Eudract number
2012-001005-25
Research summary
The purpose of this study is to obtain information regarding the safety and efficacy of a product called CHF 6001, developed by Chiesi Farmaceutici and compare it to placebo and to fluilast (a drug of the same class as CHF 6001 given by mouth, which is already on the market) for the treatment of COPD, a disease of the lungs. The study drug is being developed as an anti-inflammatory drug to treat some pulmonary diseases such as COPD. These cause the airways to become narrowed and the lungs to become damaged as a result of chronic or long term inflammation. This leads to limited air flow to and from the lungs, which causes shortness of breath and other symptoms. During the study (from the screening visit to Day 29 of Period 3), the participants will discontinue all drugs for COPD and will be asked to take Salbutamol (Ventolin©), a short acting bronchodilator whenever feeling short of breath and a long acting bronchodilator, Tiotropium (Spiriva©) once per day. In addition, during each study period (28 days) either the study drug (CHF6001) or the placebo or fluilast will be administered daily. The treatments will be randomly assigned, which means that the order in which the participants receive the 3 treatments is decided by chance.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
12/NW/0454
Date of REC Opinion
31 Jul 2012
REC opinion
Further Information Favourable Opinion