Foster 100/6 mg NEXThaler Versus Foster 100/6mg Pressurized Metered-dose Inhaler (pMDI) in Patients With Controlled Asthma.

Summary

The purpose of this study is to demonstrate the non-inferiority of Foster 100/6mg NEXThaler versus Foster 100/6mg pMDI in terms of pulmonary function in asthmatic patients, as well as the effect of the test treatments in terms of additional lung function parameters and clinical outcome measures. The purpose is also to assess the safety and tolerability.

Timeline

Start

2017-10-09

Primary completion

2021-12-28

Completion

2021-12-28

Outcome

Met primary endpoint

paper The primary objective was met, with no statistically significant difference between the treatments in average pre-dose morning PEF PMID 37878325 ↗

paper the lower limit of the 95% CI above the -15 L/min non-inferiority margin PMID 37878325 ↗

Publications

• Results Zheng J, Zhang J, Fu X, Lin C, Zhang X, Mei X, Corradi M, Cappellini G, Calabro E, Zhu C, Topole E. Comparison of extrafine beclomethasone dipropionate/formoterol fumarate dry powder inhaler and pressurized metered-dose inhaler in Chinese patients with asthma: the FORTUNE study. J Asthma. 2024 Apr;61(4):360-367. doi: 10.1080/02770903.2023.2272816. Epub 2023 Nov 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Formoterol	Other / unclassified	6 mg	Inhaled
Subject	beclomethasone dipropionate	Other / unclassified	100 mg	Inhaled

Indications