TRILOGY - A Phase III Study of CHF5993 in Patients with Severe COPD.
Research type
Research Study
Full title
A 52-week, double-blind, randomized, multinational, multicentre, 2-arm parallel-group, active-controlled clinical trial of fixed combination of beclometasone dipropionate plus formoterol fumarate plus glycopyrrolate bromide administered via pMDI (CHF 5993) versus fixed combination of beclometasone dipropionate plus formoterol fumarate administered via pMDI in Patients with Chronic Obstructive Pulmonary Disease
IRAS ID
141453
Contact name
Dave Singh
Contact email
Sponsor organisation
Chiesi Farmaceutici S.p.A.
Eudract number
2013-001057-27
Clinicaltrials.gov Identifier
Research summary
Chronic Obstructive Pulmonary Disease (COPD) is considered a major public health problem globally. The disease imposes a large burden on patients, health care systems and society with increasing prevalence and mortality predicted in the coming decades.
COPD is characterised by lung damage leading to airflow restrictions which are not fully reversible. The primary cause is tobacco smoking, however other factors can trigger a similar inflammatory response, which can lead to COPD.
Inhaled bronchodilators are recommended in all current guidelines as appropriate treatment for first-line maintenance therapy for COPD. For patients who are uncontrolled with bronchodilator monotherapy, combination therapy is recommended.
The study is funded by Chiesi Farmaceutici S.p.A., who has developed a fixed combination of Beclometasone Dipropionate and Formoterol Fumarate which is marketed under the trade name Foster®, also named CHF1535.
Chiesi is now developing a triple fixed dose combination by combining Foster® with Glycopyrrolate bromide for COPD patients who would benefit from ICS/LABA and LAMA combined therapy. This triple fixed dose is named CHF 5993.The purpose of this study is to demonstrate the superiority of CHF 5993 pMDI over CHF 1535 pMDI in terms of lung function (change from baseline in pre-dose and 2 hour post-dose morning Forced Expiratory Volume in 1 second (FEV1)) and dyspnoea, after 26-week administration in COPD patients.
This study is a Phase III, double-blind, randomised, 2-arm parallel group, active-controlled study in approximately 1304 randomised patients. The study will be conducted in 14 countries at approximately 145 sites and will recruit male and female patients aged 40 years and above. A total of 8 clinic visits will be performed during the study and participants will be in the study for 55 weeks in total (including a 2 week run-in period). Patients will undergo assessments including Physical examination, ECGs, lung function tests, questionnaires completion and blood and urine tests.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
13/NW/0829
Date of REC Opinion
24 Jan 2014
REC opinion
Further Information Favourable Opinion