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CHF 5993 vs CHF 1535 in Chinese Patients With Uncontrolled Asthma
NCT07546981Phase 3
Key facts
- Status
- Recruiting
- Start
- Jun 2026
- Primary completion
- Oct 2028
- Countries
- 1
- Sponsor
- Chiesi Farmaceutici S.p.A.
- Modality
- Inhalation Devices, Small Molecules
- Conditions
- asthma
01
Overview
Phase 3, randomised, double-blind trial of beclomethasone dipropionate, formoterol and glycopyrronium bromide in asthma (2 arms), sponsored by Chiesi Farmaceutici S.p.A. Primary endpoint: Peak Forced Expiratory Volume in 1 second at 24 weeks. Started Jun 2026; status: recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
CHF 5993 pMDI HFA-152a
Experimental: CHF 5993 pMDI HFA-152a; Fixed combination of beclometasone dipropionate (BDP) 100 μg+formoterol fumarate(FF) 6 μg+glycopyrronium bromide(GB) 12.5 μg, via pressurised metered dose inhaler(pMDI) with HFA-152a propellant.
CHF 1535 pMDI HFA-134a
Comparator: CHF 1535 pMDI HFA-134a Fixed combination of BDP 100 μg+FF 6 μg, via pMDI with HFA-134a propellant.
03
Who it enrols
Chinese patients aged 18-75 with uncontrolled asthma despite medium doses of ICS+LABA, with FEV1 <80% predicted and ACQ-7 score >=1.5.
04
Endpoints
Primary
Peak Forced Expiratory Volume in 1 second
Secondary
Forced Expiratory Volume in 1 second
Peak Expiratory Flow
Asthma Control Questionnaire-7
Average use of rescue medication
Number of moderate and severe exacerbations
Time to first moderate or severe exacerbation
Average daily asthma symptoms
Percentage of asthma control days
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