BridgeMD
Tests treatment safety and results for Asthma
Official title 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
ClinicalTrials.gov ID: NCT07546981
What this study is testing
What is Experimental: Participant Group CHF 5993 pMDI HFA-152a?
Experimental: Participant Group CHF 5993 pMDI HFA-152a is an investigational medicine, given as an once-daily inhaled treatment, being studied as a potential treatment for asthma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- people must meet all of the following to be eligible for enrolment into the study:
- people must provide written informed consent prior to any study-related procedures;
- people must be male or female Chinese aged ≥18 and ≤75 years;
- people 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;
- people 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...
You likely can't join if
- people meeting any of the following criteria will be excluded from study enrolment:
- people who have a history of near fatal asthma or of a past hospitalisation for status asthmaticus or severe asthma exacerbation which, in the...
- people who have undergone hospitalisation, emergency room visit or use of systemic corticosteroids for an asthma exacerbation in the 4 weeks prior to...
- people with any asthma exacerbation or respiratory tract infection in the 4 weeks prior to the screening visit or during run-in period;
- people with any change in dose, schedule or formulation of the combination ICS+LABA in the 4 weeks prior to the screening visit;
- people who have used systemic corticosteroid medication in the 4 weeks prior to screening or slow-release corticosteroids in the 12 weeks prior to...
See the full eligibility criteria
- people must meet all of the following to be eligible for enrolment into the study:
- people must provide written informed consent prior to any study-related procedures;
- people must be male or female Chinese aged ≥18 and ≤75 years;
- people 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;
- people 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;
- people must have a pre-bronchodilator FEV1 \<80% of their predicted normal value, after appropriate wash out from bronchodilators at the screening visit.
- people must have a positive response to a reversibility test at screening.
- people must have uncontrolled asthma evidenced by a score at the ACQ-7 ≥1.5 (this criterion must be met at screening and at randomisation).
- people meeting any of the following criteria will be excluded from study enrolment:
- people 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;
- people 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;
- people with any asthma exacerbation or respiratory tract infection in the 4 weeks prior to the screening visit or during run-in period;
- people with any change in dose, schedule or formulation of the combination ICS+LABA in the 4 weeks prior to the screening visit;
- people who have used systemic corticosteroid medication in the 4 weeks prior to screening or slow-release corticosteroids in the 12 weeks prior to screening;
- people 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...
- people 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;
- people who are treated with monoclonal antibodies (e.g., anti-immunoglobulin (Ig)E or anti-IgG antibodies) or biological drugs;
- people 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 assigned by chance in this study, or are currently...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Chaoyang District, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Chaoyang District, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.