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

Chiesi

Status and phase

Completed

Phase 3

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

Drug: Symbicort® Turbohaler® plus CHF 1535 pMDI Placebo

Drug: CHF 1535 100/6 µg pMDI plus Symbicort® Turbohaler® Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03888131

CCD-01535AC1-02

Details and patient eligibility

About

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.

Enrollment

750 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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