Active Controlled Trial of CHF5993 Pressurized Metered-dose Inhaler ( pMDI) vs Symbicort®Turbuhaler® in Patients With Chronic Obstructive Pulmonary Disease ( COPD) (TRIVERSYTI)
Phase 3
Completed
NCT03197818
| Condition | COPD |
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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 | 708 participants |
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| Interventions | CHF 5993 100/6/12.5 µg, 160 µg budesonide + 4.5 µg formoterol fumarate |
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| Start date | Dec 14, 2016 |
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| Completion date | May 26, 2020 |
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| Results posted | May 27, 2026 |
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Summary
Primary Objective • To demonstrate the superiority of CHF 5993 pressurised metered dose inhaler (pMDI) over Symbicort® Turbuhaler® in terms of pulmonary function (change from baseline in pre-dose morning forced expiratory volume in the first second of a forced vital capacity manoeuvre \[FEV1\] and 2-hour post-dose morning FEV1 at Week 24). Secondary Objectives Key secondary objective: • To demonstrate the superiority of CHF 5993 pMDI over Symbicort® Turbuhaler® in terms of pulmonary function (change from baseline in pre-dose morning FEV1 and 2-hour post-dose morning FEV1 at Week 24) in the subgroup of Chinese population. Other secondary objectives: * To evaluate the effect of CHF 5993 pMDI on other lung function parameters, patient's health status and clinical outcome measures; * To collect data in order to assess the impact of study treatments on health economic outcomes; * To assess the safety and the tolerability of the study treatments.
Change From Baseline in Pre-dose Forced Expiratory Volume Within the First Second (FEV1) at Week 24
Week 24 (Visit 6) · Liters
| CHF 5993 100/6/12.5 µg - ITT Population | 0.030 Liters |
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| Symbicort Turbuhaler 160/4.5 µg - ITT Population | -0.032 Liters |
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| p-value | < 0.001 |
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| adjusted mean difference | 0.062 (95% CI 0.038–0.085) |
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Change From Baseline in 2-hour Post-dose FEV1 at Week 24
Week 24 (Visit 6) · Liters
| CHF 5993 100/6/12.5 µg - ITT Population | 0.185 Liters |
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| Symbicort Turbuhaler 160/4.5 µg - ITT Population | 0.072 Liters |
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| p-value | < 0.001 |
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| adjusted mean difference | 0.113 (95% CI 0.087–0.140) |
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Open in BENITIONS
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