Impact of GDMT in Uncontrolled Asthma Patients Receiving MHD Inhaled Corticosteroids + Long-acting β2 Agonist

NCT07718724 | Not Yet Recruiting

• 1 other identifier: D3250L00058
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Uncontrolled Asthma

Keywords

PRECISION

Outcome Measures

Primary Outcomes (2)

• Difference in the proportion of participants with a written diagnosis of "Severe Asthma" between the intervention and control groups at Week 24

  To evaluate the effect of GDMT education on diagnosis rates of severe asthma

  Week 24

• Difference in the annualized asthma exacerbation rate between the intervention and control groups at Week 48

  To evaluate the effect of GDMT education on asthma exacerbations

  Week 48

Secondary Outcomes (37)

• Difference in the proportion of participants with asthma exacerbation between the intervention and control groups at Week 48

  Week48

• Difference in the change in mean ACT score from baseline between the intervention and control groups at Week 48

  Baseline, week 48

• Change in mean ACT score from baseline in the intervention group at Week 24 and 48

  Baseline, week 24, week 48

• Change in the proportion of participants achieving asthma symptom control (ACT ≥20) from baseline in the intervention group at Week 24 and 48

  Baseline, week 24, week 48

• Difference in the proportion of participants with asthma symptom control (ACT ≥20) between the intervention and control groups at Week 48

  Week 48

Other Outcomes (19)

• Difference in the proportion of participants achieving clinical remission of asthma (CR3/CR4)f between the intervention and control groups at Week 48

  Week 48

• Characteristics of participants using biologics during the study period, including age, gender, disease duration, MH, insurance type, annual household income, asthma symptoms, comorbidities, EOS/FeNO/IgE levels, pulmonary function etc.

  During the 48-week study period

• Proportion of participants receiving maintenance OCS therapyi at Week 24 and 48

  Week 24, week 48

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention will be implemented at the hospital level.

Behavioral: Intervention group

Control group

NO INTERVENTION

No intervention action will be taken at hospital level, even patient level.

Interventions

Intervention group BEHAVIORAL

The GDMT pathway targets physicians and specialized nurses for implementation. It ensures that physicians at intervention groups conduct standardized diagnosis and treatment following GDMT, and that specialized nurses deliver patient education and follow-up reminders according to GDMT. This is achieved through regular knowledge training, provision of a series of reminder/support tools, and a bi-weekly (every 12 weeks) monitoring, and feedback system for Key Performance Indicators (KPIs).

Intervention group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Northan Jiangsu People's Hospital

Yangzhou, China

Location

Study Officials

• Kewu Huang

  Beijing Chao Yang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study employs a cluster-randomized design, with the hospital as the unit of randomization. A stratified block randomization method will be used, with the stratification factor being the historical rate of written severe asthma diagnosis (the proportion of patients on medium-to-high dose ICS-LABA therapy who received a written diagnosis of severe asthma), cutoff value refers to the median historical severe asthma diagnosis rate among all sites involved in feasibility survey. They will then be randomly allocated in a 1:1 ratio to either the intervention group or the control group (30 sites in the intervention group, 30 sites in the control group). The intervention will be implemented at the hospital level. Each site plans to recruit approximately 9 participants. Participants who meet the inclusion/exclusion criteria will be enrolled to intervention or control group after hospital cluster-randomization.

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 22, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: July 22, 2026

Record last verified: 2026-07

Locations

CN (1)