NCT03453112

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

A 12-week, Multicenter, Randomized, Double-blind, Double-dummy, 2-arm Parallel Group Study Comparing the Efficacy and Safety of Foster 100/6mg NEXThaler, 2 Inhalations b.i.d, Versus Foster 100/6mg pMDI, 2 Puffs b.i.d in Patients With Controlled Asthma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 494 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Foster 100/6mg NEXThaler	Fixed combination of beclomethasone dipropionate 100mg plus formoterol fumarate 6mg per actuation as inhalation powder with a new dry powder inhaler
DRUG	Foster 100/6mg pMDI	Fixed combination of beclomethasone dipropionate 100mg plus formoterol fumarate 6mg per actuation as pMDI with HFA\_134a propellant

Timeline

• Start date: 2017-10-09
• Primary completion: 2021-12-28
• Completion: 2021-12-28
• First posted: 2018-03-05
• Last updated: 2023-11-28

Locations

52 sites across 1 country: China