Guideline-based care for uncontrolled asthma despite regular inhaled steroid and bronchodilator treatment

Trial details

Who runs it

AstraZeneca

Trial code

NCT07718724

Record updated

24 September 2026

Original description

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.Read full original descriptionShow less

A Prospective, Multicenter, Cluster-Randomized Trial to Evaluate the Impact of Guideline-Directed Medical Therapy in Uncontrolled Asthma Patients Receiving Medium-to-High Dose Inhaled Corticosteroids Plus Long-acting β2 Agonist

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.

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

ClinicalTrials.gov NCT07718724