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

NCT07546981 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: CLI-05993AA5-05
• Study Type: interventional
• Target: 554
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Asthma

Keywords

Uncontrolled asthma; Triple therapy; HFA-152a; Pressurized metered-dose inhaler; China

Outcome Measures

Primary Outcomes (1)

• Peak FEV1

  FEV1 = forced expiratory volume in the first second

  At week 24

Secondary Outcomes (8)

• Peak FEV1, FEV1, FEV1 area under curve(AUC)0-3h normalised by time

  up to 24 weeks

• PEF

  at week 24

• ACQ-7 score

  up to 24 weeks

• Average use of rescue medication

  at week 24

• The number of moderate and severe exacerbations

  at week 24

Study Arms (2)

CHF 5993 pMDI HFA-152a

EXPERIMENTAL

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.

Drug: Experimental: Participant Group CHF 5993 pMDI HFA-152a

CHF 1535 pMDI HFA-134a

ACTIVE COMPARATOR

Comparator: CHF 1535 pMDI HFA-134a Fixed combination of BDP 100 μg+FF 6 μg, via pMDI with HFA-134a propellant.

Other: Active Comparator: CHF 1535 100/6 μg pMDI HFA-134a

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)

CHF 5993 pMDI HFA-152a

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).

CHF 1535 pMDI HFA-134a

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must provide written informed consent prior to any study-related procedures;
• Subjects must be male or female Chinese aged ≥18 and
• ≤75 years;
• Subjects must have a documented history of asthma for at least 1 year and asthma must have been diagnosed before the subject's age of 40;
• Subjects must have uncontrolled asthma, receiving double therapy only on medium doses of ICS in combination with LABA at a stable dose for at least 4 weeks prior to screening;
• Subjects must have a pre-bronchodilator FEV1 \<80% of their predicted normal value, after appropriate wash out from bronchodilators at the screening visit.
• Subjects must have a positive response to a reversibility test at screening.
• Subjects must have uncontrolled asthma evidenced by a score at the ACQ-7 ≥1.5 (this criterion must be met at screening and at randomisation).

You may not qualify if:

• Subjects meeting any of the following criteria will be excluded from study enrolment:
• Subjects who have a history of near fatal asthma or of a past hospitalisation for status asthmaticus or severe asthma exacerbation which, in the judgement of the Investigator, may place the subject at undue risk;
• Subjects who have undergone hospitalisation, emergency room visit or use of systemic corticosteroids for an asthma exacerbation in the 4 weeks prior to the screening visit or during the run-in period;
• Subjects with any asthma exacerbation or respiratory tract infection in the 4 weeks prior to the screening visit or during run-in period;
• Subjects with any change in dose, schedule or formulation of the combination ICS+LABA in the 4 weeks prior to the screening visit;
• Subjects who have used systemic corticosteroid medication in the 4 weeks prior to screening or slow-release corticosteroids in the 12 weeks prior to screening;
• Subjects who have a history of a diagnosis of chronic obstructive pulmonary disease (COPD) (according to the Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] document), cystic fibrosis, bronchiectasis or alpha- 1 antitrypsin deficiency or any other significant lung disease which may interfere with study evaluations;
• Subjects who are current smokers; ex-smokers with total cumulative exposure ≥10 pack-years; having stopped smoking 1 year or less prior to the screening visit;
• Subjects who are treated with monoclonal antibodies (e.g., anti-immunoglobulin (Ig)E or anti-IgG antibodies) or biological drugs;
• Subjects who have received an investigational drug within 2 months or six half-lives (whichever is greater) prior to the screening visit, or have been previously randomised in this study, or are currently participating in another clinical study.

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (2)

China-Japan Friendship Hospital

Beijing, Chaoyang District, China

Location

China-Japan Friendship Hospital

Beijing, Chaoyang District, China

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Chen Wang Academician, Principal Investigator

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trial INFO Chiesi Farmaceutici S.p.A.

CONTACT

+ 39 0521 2791; clinicaltrials_info@chiesi.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 23, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): October 17, 2028
• Study Completion (Estimated): October 17, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)