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

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chiesi Farmaceutici S.p.A.
• Treatments: Beclomethasone; Budesonide; Budesonide, Formoterol Fumarate Drug Combination; Formoterol Fumarate

Criteria

Inclusion Criteria:

• Adults aged ≥ 40 years, Chinese ethnicity

• Patients with COPD diagnosed at least 12 months before the screening visit.

• A smoking history of at least 10 pack years

• Post-bronchodilator FEV1 < 50% of the predicted normal value

• Post-bronchodilator FEV1/FVC ratio < 0.7

• One exacerbation in the 12 months prior the screening visit

Exclusion Criteria:

• Patients requiring OCS/antibiotics/PDE inhibitors in the 4 weeks prior to screening

• COPD exacerbation requiring OCS/antibiotics or hospitalization during the run-in period

• Known respiratory disorders other than COPD

• Diagnosis of asthma