A Study Testing the Superiority of CHF 1535 pMDI 800/24µg Total Daily Dose Compared With CHF 718 pMDI 800µg Total Daily Dose in Adults With Asthma on Medium or High-Dose Inhaled Corticosteroid

Summary

Compare the superiority of CHF 1535 versus CHF 718 in subjects with asthma who are on medium or high dose inhaled corticosteroids.

Timeline

Start

2022-08-31

Primary completion

2024-06-24

Completion

2024-06-24

Outcome

Met primary endpoint

registry analysis (superiority test); CHF 1535 pMDI vs CHF 718 pMDI; p <0.001; Adjusted mean difference 0.104 (95% CI 0.061 to 0.148); ANCOVA NCT05292586 ↗

paper The primary and the key secondary objectives were met, with BDP/FF vs. BDP adjusted mean differences of 104 (95% confidence interval 61, 148) mL PMID 41231513 ↗

Publications

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• Background Lee LA, Bailes Z, Barnes N, Boulet LP, Edwards D, Fowler A, Hanania NA, Kerstjens HAM, Kerwin E, Nathan R, Oppenheimer J, Papi A, Pascoe S, Brusselle G, Peachey G, Sule N, Tabberer M, Pavord ID. Efficacy and safety of once-daily single-inhaler triple therapy (FF/UMEC/VI) versus FF/VI in patients with inadequately controlled asthma (CAPTAIN): a double-blind, randomised, phase 3A trial. Lancet Respir Med. 2021 Jan;9(1):69-84. doi: 10.1016/S2213-2600(20)30389-1. Epub 2020 Sep 9.
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Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Beclomethasone Dipropionate/Formoterol Fumarate	Unknown	—	Inhaled
Comparator	beclomethasone dipropionate	Other / unclassified	100 ug	Inhaled

Indications