RecruitingPhase 2NCT07301736

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


Sponsor

Chiesi Farmaceutici S.p.A.

Enrollment

780 participants

Start Date

Dec 17, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two versions of the same triple-combination inhaler (called CHF5993) for people with mild to moderate asthma — one uses a newer, more environmentally friendly propellant (HFA-152a) and the other uses the standard propellant. Researchers want to confirm that the two versions work equally well. **You may be eligible if...** - You are between 18 and 75 years old - You have had an asthma diagnosis for at least 6 months, diagnosed before age 50 - You are a non-smoker or ex-smoker - You have a BMI between 18 and 35 - You are already on a stable asthma treatment with an inhaled steroid (with or without a long-acting bronchodilator) **You may NOT be eligible if...** - You are a current smoker or have smoked heavily in the past - Your asthma is severe or poorly controlled - You have other significant lung conditions - You have recently had a respiratory infection or asthma attack - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCHF5993 pMDI with HFA-152a

two puffs BID (twice daily)

DRUGCHF5993 pMDI with HFA-134a

two puffs BID

DRUGCHF718 pMDI with HFA-134a

two puffs BID


Locations(1)

Elpida Trials - Parloes Hub

Dagenham, United Kingdom

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NCT07301736


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