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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Uncontrolled Asthma
• Intervention / Treatment: Behavioral: Intervention group

Detailed Description

This study is a prospective, multicenter, cluster-randomized trial conducted in China, designed to evaluate the application effect of Guideline-Directed Medical Therapy (GDMT). A scientific committee will be established to be responsible for developing GDMT educational materials and facilitating the implementation of GDMT. The study will introduce a GDMT pathway in intervention group aimed at guiding physicians and specialized nurses in the diagnosis and management of participants who are receiving medium- to high-dose ICS-LABA therapy but have uncontrolled asthma.

This study plans to include approximately 60 study sites and consecutively recruit approximately 540 participants. These sites will cover as many provinces and cities as possible to balance geographical distribution. For the 60 selected sites meeting the hospital qualification requirements, a stratified block randomization method will be used, with the stratification factor being the prior written diagnosis rate for severe asthma (the proportion of severe asthma written diagnoses among patients with asthma on medium-to-high dose ICS-LABA). Sites will be randomly allocated in a 1:1 ratio to either the intervention group or the control group (30 sites per group). To minimize selection bias, each site will consecutively enroll 9 participants who meet all inclusion criteria and have provided signed informed consent. All participants must complete the baseline study assessments before entering the study. This is a cluster-randomized interventional study, with an expected duration of 48 weeks. The intervention is implemented at the hospital level. Participants in the two groups will be managed as follows:

• Intervention Group: Physicians at the study sites will receive GDMT-related training and manage participants according to the GDMT diagnosis and treatment pathway.
• Control Group: Physicians at the study sites will manage participants using usual clinical care.

Participant data (including but not limited to: demographic characteristics, number of exacerbations, asthma medication use, ACT scores, pulmonary function, SGRQ scores, medical costs) will be collected according to the Schedule of Study Activities.

The benefits and effectiveness of GDMT will be determined by assessing changes in physician behavior, improvements in patient outcomes, and savings in healthcare resources.

The intervention consists of 5 distinct components: routine training, GDMT education, clinical monitoring, targeted training, and material revision.

• Study Type: Interventional
• Enrollment (Estimated): 540
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• China
  • Yangzhou, China
    • Northan Jiangsu People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; The intervention will be implemented at the hospital level.	Behavioral: Intervention group; 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).
No Intervention: Control group; No intervention action will be taken at hospital level, even patient level.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in the proportion of participants with asthma exacerbation between the intervention and control groups at Week 48	To evaluate the effect of GDMT education on asthma control	Week48
Difference in the change in mean ACT score from baseline between the intervention and control groups at Week 48	To evaluate the effect of GDMT education on asthma control	Baseline, week 48
Change in mean ACT score from baseline in the intervention group at Week 24 and 48	To evaluate the effect of GDMT education on asthma control	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	To evaluate the effect of GDMT education on asthma control	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	To evaluate the effect of GDMT education on asthma control	Week 48
Difference in the proportion of participants achieved the Minimal Clinically Important Difference (MCID) in asthma symptom control (ACT improvement ≥3 points) between the intervention and control groups at Week 48	To evaluate the effect of GDMT education on asthma control	Week 48
The proportion of participants achieved ACT MCID (ACT improvement ≥3 points) in the intervention group at Week 24 and 48	To evaluate the effect of GDMT education on asthma control	Week 24, week 48
Difference in pre-bronchodilator Forced Expiratory Volume in 1 second (Pre-BD FEV1) between the intervention and control groups at Week 48	To evaluate the effect of GDMT education on pulmonary function	Week 48
Change in pre-bronchodilator FEV1 (Pre-BD FEV1) from baseline in the intervention group at Week 24 and 48	To evaluate the effect of GDMT education on pulmonary function	Baseline, week 24, week 48
Difference in the proportion of participants with combined persistent airflow obstruction (PAO, FEV1/FVC <70%) between the intervention and control groups at Week 48	To evaluate the effect of GDMT education on pulmonary function	Week 48
Difference in St. George's Respiratory Questionnaire (SGRQ) scores (total and domain scores) between the intervention and control groups at Week 48	To evaluate the effect of GDMT education on quality of life	Week 48
Change in SGRQ scores from baseline in the intervention group at Week 24 and Week 48	To evaluate the effect of GDMT education on quality of life	Baseline, week 24, week 48
Difference in the proportion of participants who achieved SGRQ MCID (decrease in total score ≥4 points) between the intervention and control groups at Week 48	To evaluate the effect of GDMT education on quality of life	Week 48
The proportion of participants achieved SGRQ MCID (decrease in total score ≥4 points) in the intervention group at Week 24 and 48	To evaluate the effect of GDMT education on quality of life	Week 24, week 48
Difference in the proportion of participants with a written diagnosis of "Severe Asthma" between the intervention and control groups at Week 48	To evaluate the effect of GDMT education on diagnosis rate	Week 48
Difference in the time to written diagnosis of "Severe Asthma" between the intervention and control groups during the 48-week study period;	To evaluate the effect of GDMT education on diagnosis rate	During the 48-week study period
Reasons for not meeting the diagnostic criteriac for severe asthma among participants in the intervention group not diagnosed with "severe asthma" at Week 48	To evaluate the effect of GDMT education on diagnosis rate	Week 48
Difference in the proportion of participants with peripheral blood eosinophil (bEOS) test records within the past 3 months, excluding those during asthma exacerbation, between the intervention and control groups at Week 24 and 48	To evaluate the effect of GDMT education on biomarkers tests rate	Week 24, week 48
Difference in the proportion of participants with Fractional exhaled Nitric Oxide (FeNO) test records within the past 3 months between the intervention and control groups at Week 24 and 48	To evaluate the effect of GDMT education on biomarkers tests rate	Week 24, week 48
Difference in the proportion of participants with Immunoglobulin E (IgE) test records within the past 3 months between the intervention and control groups at Week 24 and 48	To evaluate the effect of GDMT education on biomarkers tests rate	Week 24, week 48
Difference in the cumulative number of bEOS test records between the intervention and control groups during the 48-week study period	To evaluate the effect of GDMT education on biomarkers tests rate	During the 48-week study period
Difference in the cumulative number of IgE test records between the intervention and control groups during the 48-week study period	To evaluate the effect of GDMT education on biomarkers tests rate	During the 48-week study period
Difference in the cumulative number of FeNO test records between the intervention and control groups during the 48-week study period	To evaluate the effect of GDMT education on biomarkers tests rate	During the 48-week study period
Difference in the proportion of participants with typing records between the intervention and control groups over the 48-week study period	To evaluate the effect of GDMT education on typing records	Week 48
Difference in the time to first asthma typing record between the intervention and control groups during the 48-week study period	To evaluate the effect of GDMT education on typing records	During the 48-week study period
Difference in the proportion of participants with record of eosinophilic asthma phenotype between the intervention and control groups over the 48-week study period	To evaluate the effect of GDMT education on typing records	Week 48
Difference in the time to first eosinophilic asthma phenotype record between the intervention and control groups during the 48-week study period	To evaluate the effect of GDMT education on typing records	During the 48-week study period
Difference in the proportion of participants with a recorded Type 2 (T2) asthma phenotype between the intervention and control groups during the 48-week study period	To evaluate the effect of GDMT education on typing records	Week 48
Difference in the proportion of participants with record of allergic asthma phenotype between the intervention and control groups during the 48-week study period	To evaluate the effect of GDMT education on typing records	Week 48
Difference in the cumulative number of pulmonary function test records between the intervention and control groups during the 48-week study period	To evaluate the effect of GDMT education on pulmonary function test utilization	Week 48
Difference in the proportion of participants using biologics between the intervention and control groups during the 48-week study period	To evaluate the effect of GDMT education on biologic utilization	Week 48
Difference in the duration of biologic use between the intervention and control groups	To evaluate the effect of GDMT education on biologic utilization	During the 48-week study period
Distribution of different treatment pattern in the intervention group during the 48-week study period	To evaluate the effect of GDMT education on treatment pattern	During the 48-week study period
Distribution of different treatment pattern in the control group at Week 48	To evaluate the effect of GDMT education on treatment pattern	Week 48
Difference in the proportion of participants regularly completing scheduled follow-ups visitse between the intervention and control groups over the 48-week study period	To evaluate the effect of GDMT education on regular follow-up visits	Week 48
Difference in the drop-out rate between the intervention and control groups at Week 48	To evaluate the effect of GDMT education on regular follow-up visits	Week 48
Subgroup analyses will be conducted as appropriate; planned subgroups to explore include: Hospital classification, Participant classification.	Describe the differences in physician behavior, participant benefit, and healthcare resource conservation across different hospital and participant subgroups after GDMT education	During the 48-week study period

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in the proportion of participants achieving clinical remission of asthma (CR3/CR4)f between the intervention and control groups at Week 48	To evaluate the effect of GDMT education on clinical remission of asthma	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.	To describe the characteristics of participants using biologics	During the 48-week study period
Proportion of participants receiving maintenance OCS therapyi at Week 24 and 48	To assess the effect of GDMT education on oral corticosteroid (OCS) use	Week 24, week 48
Difference in the accumulative dose of maintenance OCS received between the intervention and control groups at Week 24 and 48	To assess the effect of GDMT education on oral corticosteroid (OCS) use	Week 24, week 48
Difference in the reduction of maintenance OCS dose among biologic users between the intervention and control groups at Week 48	To assess the effect of GDMT education on oral corticosteroid (OCS) use	Week 48
Difference in proportion of participants with asthma-related hospitalization between the intervention and control groups during the 48-week study period	To assess the effect of GDMT education on healthcare resource utilization	Week 48
Difference in the average annual asthma-related hospitalization frequency between the intervention and control groups during the 48-week study period	To assess the effect of GDMT education on healthcare resource utilization	During the 48-week study period
Difference in the average annual length of asthma-related hospital stay between the intervention and control groups during the 48-week study period	To assess the effect of GDMT education on healthcare resource utilization	During the 48-week study period
Difference in proportion of participants with asthma-related ICU stay between the intervention and control groups during the 48-week study period	To assess the effect of GDMT education on healthcare resource utilization	During the 48-week study period
Difference in the average annual length of asthma-related ICU stay between the intervention and control groups during the 48-week study period	To assess the effect of GDMT education on healthcare resource utilization	During the 48-week study period
Difference in proportion of participants with asthma-related emergency department visits between the intervention and control groups during the 48-week study period	To assess the effect of GDMT education on healthcare resource utilization	During the 48-week study period
Difference in the average number of emergency department visits between the intervention and control groups during the 48-week study period	To assess the effect of GDMT education on healthcare resource utilization	During the 48-week study period
Difference in the number of prescribed medications types between the intervention and control groups during the 48-week study period	To assess the effect of GDMT education on healthcare resource utilization	During the 48-week study period
Difference in the average annualized asthma-related medical costsj between the intervention and control groups during the 48-week study period	To assess the effect of GDMT education on healthcare resource utilization	During the 48-week study period
Difference in the change from baseline in Impulse Oscillometry (IOS) parameters (R5, R20, X5, Fres, AX) between the intervention and control groups at Week 24 and 48	To evaluate the effect of GDMT education on pulmonary function (IOS)	Week 24, week 48
Reasons for not initiating biologics in participants with severe asthma in the intervention group during the study period	To describe reasons for not initiating biologics in severe asthma during the study period, and reasons for participants discontinuing biologics	During the 48-week study period
Reasons for discontinuing biologics in intervention group during the study period	To describe reasons for not initiating biologics in severe asthma during the study period, and reasons for participants discontinuing biologics	During the 48-week study period
Difference in number of asthma-related comorbidities typesk in written records between the intervention and control groups during the 48-week study period	To evaluate the effect of GDMT education on comorbidity recording	During the 48-week study period
Treatment satisfaction in the intervention and control groups at Week 48	To evaluate the effect of GDMT education on participant treatment satisfaction	Week 48

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Kewu Huang, Beijing Chao Yang Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028

Study Registration Dates

• First Submitted: July 16, 2026
• First Submitted That Met QC Criteria: July 16, 2026
• First Posted (Actual): July 22, 2026

Study Record Updates

• Last Update Posted (Actual): July 22, 2026
• Last Update Submitted That Met QC Criteria: July 16, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: PRECISION
• Other Study ID Numbers: D3250L00058

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No