Test of CHF 5993 inhaler against CHF 1535 in Chinese adults with uncontrolled asthma on medium-dose ICS+LABA

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3, randomized, controlled study conducted in China comparing CHF 5993 pMDI HFA-152a to CHF 1535 pMDI HFA-134a in adults with asthma that remains uncontrolled on medium-dose ICS+LABA. Participants undergo a run-in period with the reference product, followed by a 24-week treatment period to compare efficacy and safety, with total participation lasting about 27 weeks. Safety data, including adverse events of interest like cough, are collected from informed consent through study completion, and spirometry is performed throughout, including after treatment discontinuation if applicable. The study uses a parallel-group design and focuses on patients with a documented history of asthma and ACQ-7 scores indicating poor control.

Why it matters

Who can join: the full rules

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.

Where it's running

• China-Japan Friendship Hospital
  Beijing, Chaoyang District, China Recruiting
• China-Japan Friendship Hospital
  Beijing, Chaoyang District, China Recruiting

Study contacts

• Principal investigator: Chen Wang Academician, Principal Investigator — China-Japan Friendship Hospital
• Study coordinator: Clinical Trial INFO Chiesi Farmaceutici S.p.A.
• Email: clinicaltrials_info@chiesi.com
• Phone: + 39 0521 2791

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.