NCT07301736

Therapeutic Equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a in Subjects With Mild to Moderate Asthma

A Phase II Multinational, Multicentre, Double-blind, Randomised, Active-controlled, 3-way Cross-over Study to Evaluate the Therapeutic Equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a Versus CHF5993 pMDI 100/6/12.5 µg HFA-134a in Subjects With Mild to Moderate Asthma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 780 (estimated)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will compare an asthma inhaler that uses a new climate friendly alternative propellant to an asthma inhaler with an existing propellant. We want to make sure both versions of the inhaler work the same way for people with mild to moderate asthma.

Detailed description

This global study aims to compare whether the investigational inhaler with the new HFA-152a propellant is as safe, effective and well tolerated in patients with asthma as the inhalers that use the existing HFA-134a propellant. HFA-152a is a propellant gas that is designed to have a lower global warming potential and to be more climate friendly. The study will be conducted in Europe, Latin America, Ukraine, South Africa and United Kingdom. It is planned to randomize 468 patients.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	CHF5993 pMDI with HFA-152a	two puffs BID (twice daily)
DRUG	CHF5993 pMDI with HFA-134a	two puffs BID
DRUG	CHF718 pMDI with HFA-134a	two puffs BID

Timeline

• Start date: 2025-12-17
• Primary completion: 2027-06-03
• Completion: 2027-06-03
• First posted: 2025-12-24
• Last updated: 2026-01-12

Locations

1 site across 1 country: United Kingdom