Guideline-Directed Medical Therapy to Help Uncontrolled Asthma on 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 prospective, multicenter, cluster-randomized trial conducted in China. It will introduce a GDMT pathway and educational materials to guide physicians and specialized nurses in managing patients on medium- to high-dose ICS-LABA who remain uncontrolled. The study aims to enroll about 540 participants across roughly 60 sites, randomized 1:1 to intervention or usual care, with follow-up every 12 weeks for up to 48 weeks. A scientific committee will develop GDMT materials and monitor implementation to assess disease management outcomes. The design emphasizes real-world applicability with consecutive enrollment and stratified site randomization to balance prior severe asthma diagnosis rates.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Sign the informed consent form before any study-related procedures;
2. Age 18-75 years (inclusive) at Visit 0;
3. 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;
4. Under the usage of MD/HD ICS-LABA;
5. Experienced one or more exacerbations within the past year;

Exacerbation is defined as meeting any of the following criteria:

1. 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;
2. 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);
3. Hospitalization for asthma (defined as admission to a hospital and/or being evaluated and treated in a healthcare facility for ≥ 24 hours).

Exclusion Criteria:

1. Previous written diagnosis as "Severe Asthma"; Diagnosis of Severe Asthma includes: severe asthma, or related diagnoses containing "severe asthma", or "bronchial asthma (severe)".
2. Imaging suggests the presence of bullae or cystic bronchiectasis;
3. Currently participating in other interventional studies;
4. Previous use of biologics for asthma treatment;
5. Using systemic glucocorticoids for other diseases;
6. History of respiratory tract infection within 4 weeks prior to Visit 0 (upper respiratory tract infections and lower respiratory tract infections);
7. 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.

Where it's running

• Research Site
  Chifeng, China Recruiting
• Research Site
  Chengdu, China Not yet recruiting
• Research Site
  Dongyang, China Not yet recruiting
• Research Site
  Hefei, China Not yet recruiting
• Research Site
  Hefei, China Not yet recruiting
• Research Site
  Hengyang, China Not yet recruiting

Study contacts

• Principal investigator: Kewu Huang — Beijing Chao Yang Hospital
• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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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.