Triple 6 - A Phase III Study of CHF5993 in Patients with Severe COPD
Research type
Research Study
Full title
A 52-week, Double Blind, Double dummy, Randomized, Multinational, Multicentre, 3-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 tiotropium bromide and versus fixed combination of beclometasone dipropionate plus formoterol fumarate administered via pMDI and tiotropium bromide in patients with Chronic Obstructive Pulmonary Disease.
IRAS ID
138720
Contact name
Jørgen Vestbo
Contact email
Sponsor organisation
Chiesi Farmaceutici S.p.A.
Eudract number
2013-000063-91
Clinicaltrials.gov Identifier
Research summary
Chronic Obstructive Pulmonary Disease (COPD) is a partically treatable disease that has varying severities in individual patients. Chronic cigarette smoking is the major cause of the disease, which is characterised by lung damage, leading to airflow restrictions which are not fully reversible. The aim of treatment for the disease is, therefore, to reverse some of this airway obstruction, if possible.
Inhaled corticosteroids (ICS), long acting beta-2-agonists (LABA) and long-acting muscarinic antagonists (LAMA) are widely used to control symptoms of COPD. The ICS, like beclometasone, reduce the inflammation of the lungs. The LABAs and LAMA, like formoterol and tiotropium respectively, are bronchodilators, opening the airways to make breathing easier.
Chiesi has developed a combination of beclometasone 100 micrograms plus formoterol 6 micrograms in a single inhaler, marketed under the trade name of Fostair® in the UK. Chiesi is now developing a new combination adding a LAMA component, glycopyrrolate, to Fostair®. The test product is known as CHF5993 pMDI (administered via metered dose inhaler).
The purpose of this study is to determine if the triple combination of beclometasone dipropionate+Formoterol fumarate+Glycopyrrolate bromide is effective for the treatment of patients with severe to very severe COPD. It is therefore proposed that this would provide physicians and patients with more flexibility in the choice of treatment in order to get better control of symptoms in patients with severe COPD.This is a Phase III, double-blind, double-dummy, randomised, multinational, multicentre, 3-arm parallel-group, active-controlled study in approximately 2580 randomised patients. The primary objective is to demonstrate the superiority of CHF 5993 pMDI over Tiotropium in terms of moderate and severe COPD exacerbation rate over 52 weeks of treatment.
The study will be conducted in 16 to 20 countries at approximately 200 study sites and will recruit male and female patients aged ≥ 40 years. In addition, a total of 550 randomised patients will be selected for the evaluation of pharmacoketic parameters.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
13/EM/0375
Date of REC Opinion
4 Nov 2013
REC opinion
Further Information Favourable Opinion