NCT03888131

Foster® pMDI (CHF 1535) Versus Symbicort® Turbohaler in COPD Patient

A 24-week, Double Blind, Double Dummy, Randomized, Multicentre, 2-arm Parallel Group, Active Controlled Clinical Trial of Fixed Combination of Beclometasone Dipropionate Plus Formoterol Fumarate Administered Via pMDI (CHF 1535) Versus the Fixed Combination of Budesonide Plus Formoterol Fumarate (Symbicort® Turbohaler®) in Patients With Chronic Obstructive Pulmonary Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 750 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to demonstrate the non-inferiority of CHF1535 pMDI versus Symbicort® Turbohaler® in terms of lung function parameters and patients reported outcomes and to assess its safety and tolerability.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	CHF 1535 100/6 µg pMDI plus Symbicort® Turbohaler® Placebo	Fixed combination of beclometasone dipropionate 100 µg plus formoterol fumarate 6 µg (BDP/FF)
DRUG	Symbicort® Turbohaler® plus CHF 1535 pMDI Placebo	Fixed combination of 160 µg budesonide + 4.5 µg formoterol fumarate (BUD/FF)

Timeline

• Start date: 2018-07-30
• Primary completion: 2022-05-06
• Completion: 2022-05-06
• First posted: 2019-03-25
• Last updated: 2024-11-25

Locations

53 sites across 1 country: China