Trimaran_V1_03Aug2015
Research type
Research Study
Full title
A 52 WEEK, RANDOMIZED, DOUBLE BLIND, MULTINATIONAL, MULTICENTRE, ACTIVE CONTROLLED, 2-ARM PARALLEL GROUP TRIAL COMPARING CHF 5993 100/6/12.5 µg pMDI (FIXED COMBINATION OF EXTRAFINE BECLOMETASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE PLUS GLYCOPYRRONIUM BROMIDE) TO CHF 1535 100/6 µg pMDI (FIXED COMBINATION OF EXTRAFINE BECLOMETHASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE) IN PATIENTS WITH ASTHMA UNCONTROLLED ON MEDIUM DOSES OF INHALED CORTICOSTEROIDS IN COMBINATION WITH LONG-ACTING β2-AGONISTS
IRAS ID
190278
Contact name
Sandrine Corre
Contact email
Sponsor organisation
Chiesi Farmaceutici S.p.A.
Eudract number
2015-000716-18
Duration of Study in the UK
2 years, 5 months, 1 days
Research summary
Inhaled corticosteroids (ICSs) and long acting beta-2-agonists (LABAs) are widely used to control asthma symptoms. The ICSs reduce the inflammation of the lungs. The LABAs are bronchodilators, which means they work by opening up the air passages in the lungs so that air can flow into the lungs more freely, thus making breathing easier.
However, a sizeable proportion of asthmatic patients have inadequate control of their symptoms despite this standard treatment of ICS plus LABA. To improve their asthma control and reduce the exacerbation risk, the addition of a second bronchodilator called long-acting muscarinic antagonist (LAMA) or anticholinergic treatment is an alternative approach under investigation.
The sponsor, Chiesi, is developing a new triple fixed combination (CHF 5993) in one inhaler for uncontrolled asthmatic patients, composed by a LAMA in addition to the standard treatment ICS+LABA licensed by Chiesi (called CHF 1535).
The purpose of this study is to provide physicians and patients with more information regarding the efficacy and safety of the study drug (CHF 5993) in asthmatic when given for a long period (1 year). The study medicine CHF 5993 will also be compared to the treatment CHF 1535.
Patients who have controlled asthma under ICS plus LABA will be approached to take part in the study. There will be a two week run-in period on CHF 1535 followed by a 52 week treatment period on the randomised treatment.
It is expected that approximately 1148 patients will be included in the study in about 200 sites.
A total of 8 clinic visits (V0 to V7) will be performed during the study.
Total study duration (V0 to V7) will be 55 weeks.
Chiesi Farmaceutici S.p.A a drug company, is funding the study.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
15/NW/0832
Date of REC Opinion
4 Dec 2015
REC opinion
Further Information Favourable Opinion