BENITIONSClinical Trial Intelligence

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

ConditionAsthma
PhasePhase 3
SponsorChiesi Farmaceutici S.p.A.
StatusCompleted
Enrollment1,377 participants
InterventionsBeclomethasone Dipropionate/Formoterol Fumarate, Beclomethasone Dipropionate
Start dateAug 31, 2022
Completion dateJun 24, 2024
Results postedSep 4, 2025

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 pMDI0.279 liter
CHF 718 pMDI0.174 liter
p-value<0.001
Adjusted mean difference0.104 (95% CI 0.061–0.148)

Open in BENITIONS View on ClinicalTrials.gov

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