Impact of GDMT in Uncontrolled Asthma Patients Receiving MHD Inhaled Corticosteroids + Long-actin… (NCT07718724) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Impact of GDMT in Uncontrolled Asthma Patients Receiving MHD Inhaled Corticosteroids + Long-acting β2 Agonist
China540 participantsStarted 2026-08-15
Plain-language summary
The primary objective of this study is to evaluate whether GDMT can bring significant benefits to disease management in uncontrolled asthma patients receiving medium- to high-dose ICS-LABA.
* The intervention period will be up to 48 weeks;
* The frequency of follow-up is every 12 weeks.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Sign the informed consent form before any study-related procedures;
. Age 18-75 years (inclusive) at Visit 0;
. Have a written diagnosis of asthma for more than 6 months prior to Visit 0, and have evidence of reversible airflow limitation prior to Visit 0. Evidence of reversible airflow limitation includes: post-bronchodilator increase in Forced Expiratory Volume in 1 second (FEV1) of ≥12% and an absolute increase of ≥200 mL, or average daily diurnal Peak Expiratory Flow (PEF) variability \>10%, or an increase in FEV1 of ≥12% and an absolute increase of ≥200 mL compared to baseline after 4 weeks of treatment containing ICS, or a positive bronchial provocation test record. If no prior record exists, reversible airflow limitation must be confirmed and documented via a bronchodilator test during Visit 0;
. Under the usage of MD/HD ICS-LABA;
. Experienced one or more exacerbations within the past year;
. Use of systemic corticosteroids (or a temporary increase in the stable dose of baseline oral corticosteroids) for at least 3 days; a single injection of a depot long-acting corticosteroid can be considered equivalent to a 3-day course of systemic corticosteroids;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in the proportion of participants with a written diagnosis of "Severe Asthma" between the intervention and control groups at Week 24
Timeframe: Week 24
2
Difference in the annualized asthma exacerbation rate between the intervention and control groups at Week 48
. An emergency department or urgent care site visit for asthma (defined as being evaluated and treated in the emergency department or urgent care site for \< 24 hours) requiring the use of systemic corticosteroids for at least 3 days (as described above);
. Hospitalization for asthma (defined as admission to a hospital and/or being evaluated and treated in a healthcare facility for ≥ 24 hours).
Exclusion criteria
. Previous written diagnosis as "Severe Asthma"; Diagnosis of Severe Asthma includes: severe asthma, or related diagnoses containing "severe asthma", or "bronchial asthma (severe)".
. Imaging suggests the presence of bullae or cystic bronchiectasis;
. Currently participating in other interventional studies;
. Previous use of biologics for asthma treatment;
. Using systemic glucocorticoids for other diseases;
. History of respiratory tract infection within 4 weeks prior to Visit 0 (upper respiratory tract infections and lower respiratory tract infections);
. Any significant disease or disorder (e.g., cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, endocrine/metabolic, malignant, psychiatric, or significant physical impairment, etc.) which, in the opinion of the investigator, may put the patient at risk because of participation in the study, or may influence the results of the study, or the patient's ability to comply with GDMT.