A Study Testing the Superiority of CHF 1535 pMDI 800/24µg Total Daily Dose Compared With CHF 718 pMDI 800µg Total Daily Dose in Adults With Asthma on Medium or High-Dose Inhaled Corticosteroid
Phase 3
Completed
NCT05292586
| Condition | Asthma |
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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 | 1,377 participants |
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| Interventions | Beclomethasone Dipropionate/Formoterol Fumarate, Beclomethasone Dipropionate |
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| Start date | Aug 31, 2022 |
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| Completion date | Jun 24, 2024 |
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| Results posted | Sep 4, 2025 |
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Summary
Compare the superiority of CHF 1535 versus CHF 718 in subjects with asthma who are on medium or high dose inhaled corticosteroids.
1_Change From Baseline in FEV1 AUC0-12h Normalised by Time at Week 12
Baseline (pre-dose on Week 0) and Week 12. · liter
| CHF 1535 pMDI | 0.279 liter |
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| CHF 718 pMDI | 0.174 liter |
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| p-value | <0.001 |
| Adjusted mean difference | 0.104 (95% CI 0.061–0.148) |
Open in BENITIONS
View on ClinicalTrials.gov
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