drugset / Trial / NCT03453112

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

NCT03453112

Phase 3 Completed 494 enrolled Chiesi Farmaceutici S.p.A.
RandomizedParallel-groupQuadruple-blindTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Formoterol Other / unclassified 6 mg Inhaled
Subject beclomethasone dipropionate Other / unclassified 100 mg Inhaled

Indications