Efficacy and Safety of CHF 5993 100/6/12.5 μg HFA-152a pMDI in Patients With Asthma Uncontrolled on Medium Doses of Inhaled Corticosteroids in Combination With Long-acting ß2-agonists

Sponsor
Chiesi Farmaceutici S.p.A.
Study ID
NCT07546981
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Experimental: Participant Group CHF 5993 pMDI HFA-152a — DRUG
    total daily dose of BDP/FF/GB:400/24/50 μg Administration: Two (2) inhalations twice daily(BID) (i.e., 2 inhalations in the morning and 2 inhalations in the evening), total daily dose of BDP/FF/GB: 400/24/50 μg (subjects used to inhaling their asthma pMDI medications with a spacer should continue using the spacer AeroChamber Plus Flow Vu AntiStaticTM to take the pMDI study treatments)
  • Active Comparator: CHF 1535 100/6 μg pMDI HFA-134a — OTHER
    total daily dose of BDP/FF: 400/24 μg Administration: Two (2) inhalations BID (i.e., 2 inhalations in the morning and 2 inhalations in the evening), total daily dose of BDP/FF: 400/24 μg (subjects used to inhaling their asthma pMDI medications with a spacer should continue using the spacer AeroChamber Plus Flow Vu Anti-StaticTM to take the pMDI study treatments).

Study Details

This is a study comparing CHF 5993 pMDI HFA-152a with CHF 1535 pMDI HFA-134a in Chinese patients with asthma uncontrolled on medium doses of ICS+LABA.

Key Dates

First listed
Apr 23, 2026
Start date
Jun 26, 2026
Status verified
Jul 2026
Primary completion
Oct 17, 2028
Completion
Oct 17, 2028

Study Design

Enrollment
554 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Peak FEV1 [ Time Frame: At week 24 ]

Central Contacts

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