TriOptimize
Research type
Research Study
Full title
TriOptimize: A prospective non-interventional Trial on COPD patients’ health related quality of life under a fixed LAMA/LABA/ICS triple therapy and characterization of determinants of treatment adherence
IRAS ID
268709
Contact name
Elizabeth Canty
Contact email
Sponsor organisation
Chiesi Ltd
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
This is a prospective non-interventional trial to measure the health related quality of life of patients with chronic obstructive pulmonary disease (COPD) on a fixed LAMA/LABA/ICS triple therapy (Trimbow®) and characterisation of determinants of treatment adherence. COPD is a disease which causes inflammation and constriction of the airways. The primary goal of COPD therapy is the prevention of exacerbations and clinical deterioration. To achieve these goals, treatment adherence (i.e. taking medication as prescribed) is important. However, non-adherence (not taking medication as prescribed) is common in COPD and can be affected by lifestyle changes or use of multiple inhalers.
In a randomised clinical trial setting, Trimbow® has demonstrated an improvement in exacerbation reduction, lung function and quality of life. Trimbow® contains three different active substances (glycopyrronium, formoterol, and beclometasone) which are combined in one inhaler. Trimbow® has been authorised by the European regulatory authority for the treatment of COPD since July 2017.
The effects of Trimbow® on patients’ health related quality of life, adherence and clinical outcomes have not been assessed in a UK real-world setting. This non-interventional trial aims to collect data from COPD patients under routine care over a 6 month period, for whom their doctors has decided to prescribe Trimbow® as per the authorised indication.
We plan to investigate any changes in quality of life, as well as changes in lung function and the need for any additional therapy over 6 months. We also plan to investigate the adherence or reasons for non-adherence to Trimbow® as used in everyday routine.
In the UK, the plan is to enrol 200 patients across approximately 20 sites. The study is conducted and funded by the Sponsor.
REC name
London - Queen Square Research Ethics Committee
REC reference
20/LO/0212
Date of REC Opinion
7 Feb 2020
REC opinion
Favourable Opinion