Foster® pMDI (CHF 1535) Versus Symbicort® Turbohaler in COPD Patient (FORSYYN)
Phase 3
Completed
NCT03888131
| Condition | Chronic Obstructive Pulmonary Disease |
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| Phase | Phase 3 |
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| Sponsor | Chiesi Farmaceutici S.p.A. |
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| Status | Completed |
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| Enrollment | 750 participants |
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| Interventions | CHF 1535 100/6 µg pMDI plus Symbicort® Turbohaler® Placebo, Symbicort® Turbohaler® plus CHF 1535 pMDI Placebo |
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| Start date | Jul 30, 2018 |
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| Completion date | May 6, 2022 |
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| Results posted | May 12, 2026 |
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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.
Change From Baseline in Pre-dose Morning First Expiratory Volume in 1 Second (FEV1) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Baseline and week 24 · liters
| CHF 1535 100/6 µg pMDI - ITT Population | -0.020 liters |
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| Symbicort® Turbohaler® - ITT Population | -0.019 liters |
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| p-value | <0.001 |
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| Adjusted Mean Difference | -0.001 (95% CI -0.025–0.022) |
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Open in BENITIONS
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