A study comparing the effects of Trimbow to Fostair in COPD
Research type
Research Study
Full title
A randomised, open label 2-way cross-over study to compare the effects of inhaled Beclometasone/Formoterol/Glycopyrronium (TRIMBOW) pMDI to Beclometasone/Formoterol (FOSTAIR) pMDI on hyperinflation and expiratory flow limitation in moderate to severe chronic obstructive pulmonary disease (COPD).
IRAS ID
246565
Contact name
David Rogers
Contact email
Sponsor organisation
The Medicines Evaluation Unit (MEU) Ltd. (Investigator led study)
Eudract number
2018-003113-17
Duration of Study in the UK
0 years, 3 months, 13 days
Research summary
The study drugs called Trimbow and Fostair are licensed medications (they can be prescribed by a GP) for the treatment of chronic obstructive pulmonary disease (COPD). COPD is a lung disease related to smoking, which causes the airways to become narrowed and the lungs to become damaged. This leads to limited air flow to and from the lungs, which causes shortness of breath and other symptoms.
The most commonly used treatments for COPD are inhaled bronchodilators (beta agonists and muscarinic antagonists) which open up the airways and inhaled steroids which reduce inflammation of the airways.
Trimbow is a triple combination pressurised metered dose inhaler (pMDI) containing a steroid (called beclometasone diproprionate), a long acting beta agonist (called formoterol fumarate) and a long acting antagonist (called glycopyrronium bromide), which has shown to improve lung function and reduce COPD exacerbation (worsening) rates.
Fostair is a dual combination pMDI containing the same steroid and long acting beta agonist that are found in Trimbow.
The purpose of this study is to look at how the bronchodilators contained within Trimbow and Fostair effect the airways in people with COPD.
REC name
HSC REC A
REC reference
18/NI/0194
Date of REC Opinion
9 Nov 2018
REC opinion
Further Information Favourable Opinion