Evaluate efficacy and safety of 4 doses of CHF6001DPI in COPD patients
Research type
Research Study
Full title
A 24-week, multicentre, randomized, double-blind, double-dummy, placebo and active controlled, parallel group, dose ranging study to evaluate the efficacy and safety of 4 doses of CHF 6001 DPI in patients with chronic obstructive pulmonary disease (COPD) on a background therapy.
IRAS ID
211551
Contact name
Dave Singh
Contact email
Sponsor organisation
Chiesi Farmaceutici S.p.A.
Eudract number
2015-005548-32
Duration of Study in the UK
1 years, 4 months, 0 days
Research summary
The study is to obtain information on the efficacy and safety of different doses of CHF6001 in patients with Chronic Obstructive Pulmonary Disease.CHF6001 is a Phosphodiesterase-4 (PDE4) inhibitor presented as dry powder for inhalation delivered by an inhaler device. It is being developed as a potential anti-inflammatory inhaled drug to treat some lung diseases including COPD. Such conditions cause airways to become narrowed and the lungs to become damaged as a result of chronic or long term inflammation, leading to limited air flow to and from the lungs, causing shortness of breath and other symptoms. The study drug (CHF6001) could potentially reduce the inflammation in the airways which may improve these symptoms. This trial will investigate the effect of 4 different doses of CHF6001 on the amount of air participants breathe out during the first second of forced exhalation. This will occur after 12 weeks of treatment and will be used to identify the most favourable dose for further development in the target patient population. This is a randomized, double-blind, double-dummy, placebo and active controlled, parallel group, dose ranging study. Participants will receive either CHF6001 or a placebo. 4 different doses of CHF6001 are being tested. Participants will be randomly assigned to receive either a total daily dose of 800, 1600, 2400 or 3200 micrograms or placebo. The study is aimed at moderate to severe COPD patients, male and female aged 40 years or over with a history of moderate or severe exacerbations in the past year. The study will last about 29 weeks. Approximately 1102 patients will be enrolled. There are 9 study visits during which subjects will undertake various procedures including an ECG heart test and lung function, blood and urinary tests, plus completing a questionnaire. Participants will be asked to maintain an electronic diary at home.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
16/NW/0576
Date of REC Opinion
14 Oct 2016
REC opinion
Further Information Favourable Opinion