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

NCT03888131 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 750

Last updated 2026-05-12

Study results available
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Summary

Primary Objective

To demonstrate that CHF 1535 pMDI is non-inferior to Symbicort® Turbohaler® in terms of pulmonary function (change from baseline in pre-dose morning FEV1 at Week 24) in patients with COPD.

Secondary Objectives

* To evaluate the effect of CHF 1535 pMDI on other lung function parameters, and patient reported outcomes (PROs);
* To assess the safety and the tolerability of the study treatments.

Conditions

Interventions

DRUG

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

2 inhalations BID Total Daily Dose = 400/24µg

DRUG

Symbicort® Turbohaler® plus CHF 1535 pMDI Placebo

2 inhalations BID Total Daily Dose = 640/18µg

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Professor Fuqiang WEN, M.D., Ph.D. · West China Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-30
Primary Completion
2022-05-06
Completion
2022-05-06

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03888131 on ClinicalTrials.gov