Recruiting
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
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.
ClinicalTrials.gov IDNCT07546981
PhasePHASE3
Enrollment554
SponsorChiesi Farmaceutici S.p.A.
Age18 Years
SexALL
Conditions studied
Asthma
About this study
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.
Interventions
- Drug: Experimental: Participant Group CHF 5993 pMDI HFA-152a — 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)
- Other: Active Comparator: CHF 1535 100/6 μg pMDI HFA-134a — 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).
Primary outcomes
- Peak FEV1 (At week 24)
Eligibility information
Inclusion Criteria:
* Subjects must meet all of the following inclusion criteria to be eligible for enrolment into the study:
1. Subjects must provide written informed consent prior to any study-related procedures;
2. Subjects must be male or female Chinese aged ≥18 and
≤75 years;
3. 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;
4. 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;
5. Subjects must have a pre-bronchodilator FEV1 \<80% of their predicted normal value, after appropriate wash out from bronchodilators at the screening visit.
6. Subjects must have a positive response to a reversibility test at screening.
7. 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).
Exclusion Criteria:
* Subjects meeting any of the following criteria will be excluded from study enrolment:
1. 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;
2. 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;
3. Subjects with any asthma exacerbation or respiratory tract infection in the 4 weeks prior to the screening visit or during run-in period;
4. Subjects with any change in dose, schedule or formulation of the combination ICS+LABA in the 4 weeks prior to the screening visit;
5. 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;
6. 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;
7. 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;
8. Subjects who are treated with monoclonal antibodies (e.g., anti-immunoglobulin (Ig)E or anti-IgG antibodies) or biological drugs;
9. 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.
Study locations
- China-Japan Friendship Hospital, Beijing, Chaoyang District China
- China-Japan Friendship Hospital, Beijing, Chaoyang District China
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.