CLI-05993AA1-21 - TRIMBOW Study
Research type
Research Study
Full title
A phase IV, open label, multicentre, randomised, 2-way cross-over exploratory clinical trial comparing a fixed combination of beclometasone dipropionate plus formoterol fumarate plus glycopyrronium administered via pMDI (TRIMBOW®) and a fixed combination of fluticasone furoate plus vilanterol administered via DPI (RELVAR® ELLIPTA®) on lung stiffness reduction assessed through area under the reactance curve (AX) using forced oscillation technique (FOT) in patients with chronic obstructive pulmonary disease (COPD).
IRAS ID
273961
Contact name
Guido Varoli
Contact email
Sponsor organisation
Chiesi Farmaceutici S.p.A.
Eudract number
2019-002744-24
Duration of Study in the UK
1 years, 8 months, 9 days
Research summary
This is a clinical study for patients with moderate to severe chronic obstructive pulmonary disease (COPD).A total of 36 patients will take part to the study for about an overall 12 weeks period. After an initial period of 2 weeks in which patients withdraw their previous treatments for COPD and start a combined inhaled treatment with a bronchodilator plus a corticosteroid (Seretide), they will start the first of the two 4 weeks periods with the study drugs Trimbow and Relvar. These two 4 weeks treatment periods will be separated by a 2 weeks period, again with the same initial combined inhaled treatment with bronchodilator plus corticosteroid (Seretide). Then a contact will be established in about 2 weeks after the completion of the second study treatment period for safety purposes.The aim of this study is to compare the effects of the two medications Trimbow and Relvar in some parts of the lungs evaluated through a specific simple device with a reduced effort by the patients. The lung function will be also evaluated through the routinely performed spirometry, as well as the health status and COPD symptoms wlll be assessed through a specific questionnaire. Finally, the safety of the study treatments will be monitored throughout all the study period.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
20/ES/0001
Date of REC Opinion
13 Feb 2020
REC opinion
Further Information Favourable Opinion