Study to Compare the Efficacy and Safety of QVM149 With QMF149 in Patients With Asthma

Summary

The purpose of the trial was to evaluate the efficacy and safety of two different doses of QVM149 (QVM149 150/50/80 μg and QVM149 150/50/160 μg via Concept1) over two respective QMF149 doses (QMF149 150/160 μg and QMF149 150/320) μg via Concept1 in poorly controlled asthmatics as determined by pulmonary function testing and effects on asthma control.

Timeline

Start

2015-12-08

Primary completion

2019-06-14

Completion

2019-06-14

Publications

• van Zyl-Smit RN, Kerstjens HAM, Maspero J, Tanase AM, Lawrence D, Mezzi K, D'Andrea P, Chapman KR. Triple Therapy with Mometasone/Indacaterol/Glycopyrronium or Doubling the ICS/LABA Dose in GINA Step 4: IRIDIUM Analyses. Pulm Ther. 2023 Sep;9(3):395-409. doi: 10.1007/s41030-023-00234-y. Epub 2023 Aug 1.
• Kostikas K, Maspero JF, Chapman KR, Mezzi K, Jaumont X, Lawrence D, van Zyl-Smit R. Efficacy of mometasone/indacaterol/glycopyrronium in patients with inadequately controlled asthma with respect to baseline eosinophil count: Post hoc analysis of IRIDIUM study. Respir Med. 2023 Oct;217:107334. doi: 10.1016/j.rmed.2023.107334. Epub 2023 Jun 29.
• Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.
• Chapman K, van Zyl-Smit R, Maspero J, Kerstjens HAM, Gon Y, Hosoe M, Tanase AM, Pethe A, Shu X, D'Andrea P. One time a day mometasone/indacaterol fixed-dose combination versus two times a day fluticasone/salmeterol in patients with inadequately controlled asthma: pooled analysis from PALLADIUM and IRIDIUM studies. BMJ Open Respir Res. 2021 Aug;8(1):e000819. doi: 10.1136/bmjresp-2020-000819.
• Kerstjens HAM, Maspero J, Chapman KR, van Zyl-Smit RN, Hosoe M, Tanase AM, Lavecchia C, Pethe A, Shu X, D'Andrea P; IRIDIUM trial investigators. Once-daily, single-inhaler mometasone-indacaterol-glycopyrronium versus mometasone-indacaterol or twice-daily fluticasone-salmeterol in patients with inadequately controlled asthma (IRIDIUM): a randomised, double-blind, controlled phase 3 study. Lancet Respir Med. 2020 Oct;8(10):1000-1012. doi: 10.1016/S2213-2600(20)30190-9. Epub 2020 Jul 9.

Drugs

Indications