A study to evaluate the effect of inhaled CHF 6001 in adults with COPD
Research type
Research Study
Full title
A randomised, double-blind, placebo controlled, repeated dose, three way crossover study to evaluate the pharmacodynamics, pharmacokinetics and safety of two doses of CHF 6001 DPI in subjects with moderate, severe COPD.
IRAS ID
210212
Contact name
Germano LUCCI
Contact email
Sponsor organisation
Chiesi Farmaceutici S.p.A.
Eudract number
2015-005550-35
Duration of Study in the UK
0 years, 8 months, 0 days
Research summary
To evaluate the safety and efficacy of two doses of inhaled CHF 6001, a new class of anti-inflammatory drug known as a phosphodiesterase-4 (PDE4) inhibitor, in subjects with moderate to severe COPD. Each subject will be randomised to receive three treatment periods consisting of 800 micrograms twice a day (total daily dose 1600 micrograms); 1600micrograms twice a day (total daily dose 3200 micrograms) and matched placebo twice a day. Each treatment period will be separated from the following one by a wash-out period of 28 to 42 days. During the study, subjects will continue taking their usual(maintenance) COPD medication and will be provided with rescue Salbutamol 100 micrograms for ‘on demand’ use throughout the study.\n\nThe effect of the investigational drug will be evaluated by assessing the levels of markers of inflammation in subjects’ sputum, blood, lung function (i.e. breathing tests) and symptomatic benefit in comparison with placebo. \n\nThe safety of the investigational drug will be assessed through the monitoring of adverse events and adverse drug reactions, vital signs (heart rate from 12 lead ECGs and blood pressure), body weight and clinical laboratory evaluations (chemistry, haematology and urinalysis). \n\n
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
16/NW/0553
Date of REC Opinion
26 Sep 2016
REC opinion
Further Information Favourable Opinion