A Study Comparing the Effects of Trimbow to Fostair in COPD

Summary

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).

Timeline

Start

2018-12-13

Primary completion

2019-07-30

Completion

2019-08-06

Outcome

Met primary endpoint

paper BDP/F/G had a greater effect than BDP/F on FEV1 area under the curve over 12 h (AUC0-12) (mean difference 104 mls, p = 0.0071) PMID 33298062 ↗

paper RV AUC0-12 (mean difference - 163 mls, p = 0.0028). PMID 33298062 ↗

paper In COPD patients with hyperinflation, the G and F components of extrafine BDP/F/G improved FEV1, RV and small airway function. PMID 33298062 ↗

Publications

• Dean J, Panainte C, Khan N, Singh D. The TRIFLOW study: a randomised, cross-over study evaluating the effects of extrafine beclometasone/formoterol/glycopyrronium on gas trapping in COPD. Respir Res. 2020 Dec 9;21(1):323. doi: 10.1186/s12931-020-01589-5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Formoterol	Other / unclassified	5 ug	—
Comparator	Formoterol	Other / unclassified	6 ug	—
Subject	Glycopyrronium	Unknown	9 ug	—
Comparator	beclomethasone dipropionate	Other / unclassified	87 ug	Inhaled
Comparator	beclomethasone dipropionate	Other / unclassified	100 ug	Inhaled

Indications