Uncontrolled AsthmaPRECISIONNCT07718724
Impact of GDMT in Uncontrolled Asthma Patients Receiving MHD Inhaled Corticosteroids + Long-acting β2 Agonist
A study testing Intervention group in people with Uncontrolled Asthma, run by AstraZeneca at 20 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Uncontrolled Asthma
- What is being tested?
- Intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 20 sitesChina
- Study dates
- 5 Sep 2026to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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:
Show all 9Show fewer
- 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).
Who cannot join
- 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.
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
20 sites in 1 country
China20 sites, 20 recruiting
- Not yet recruiting
Research Site
Chengdu, 611130
- Recruiting
Research Site
Chifeng, 024206
- Not yet recruiting
Research Site
Dongyang, 322100
- Not yet recruiting
Research Site
Hefei, 133500
- Not yet recruiting
Research Site
Hefei, 230041
- Not yet recruiting
Research Site
Hengyang, 421001
- Not yet recruiting
Research Site
Heze, 274099
- Not yet recruiting
Research Site
Jiaxing, 314001
- Not yet recruiting
Research Site
Langfang, 065000
- Not yet recruiting
Research Site
Meizhou, 514031
- Not yet recruiting
Research Site
Quanzhou, 362000
- Not yet recruiting
Research Site
Shanghai, 200433
- Not yet recruiting
Research Site
Shiyan, 442000
- Not yet recruiting
Research Site
Tai’an, 271000
- Not yet recruiting
Research Site
Ürümqi, 830054
- Not yet recruiting
Research Site
Xi'an, 710114
- Not yet recruiting
Research Site
Yantai, 264000
- Not yet recruiting
Research Site
Yongzhou, 426100
- Not yet recruiting
Research Site
Yunnan, 661000
- Not yet recruiting
Research Site
Zhanjiang, 524001
About this study
Official title: 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.
Read the 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.
- Conditions
- Uncontrolled Asthma
- Being tested
- Intervention group
- Keywords
- PRECISION
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention will be implemented at the hospital level. Receives: Behavioral: Intervention group |
| Control group | No intervention | No intervention action will be taken at hospital level, even patient level. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Week 48
Secondary outcomes (37)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: During the 48-week study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start5 Sep 2026
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uncontrolled AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kewu Huang, Principal investigator, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07718724
- Sponsor's protocol ID
- D3250L00058
- Acronym
- PRECISION
- Status last verified
- Sep 2026
- First submitted
- 16 Jul 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07718724
- Acronym / sponsor ID
- PRECISION / D3250L00058
- Conditions
- Uncontrolled Asthma
- Keywords
- PRECISION
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 5 Sep 2026 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Intervention groupThe intervention will be implemented at the hospital level. |
| Control group | No intervention | –No intervention action will be taken at hospital level, even patient level. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention groupThe 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). | Behavioural | Intervention group |
Primary outcome
Difference in the proportion of participants with a written diagnosis of "Severe Asthma" between the intervention and control groups at Week 24
Time frame: Week 24
To evaluate the effect of GDMT education on diagnosis rates of severe asthma
Difference in the annualized asthma exacerbation rate between the intervention and control groups at Week 48
Time frame: Week 48
To evaluate the effect of GDMT education on asthma exacerbations
37 secondary outcomes
Difference in the proportion of participants with asthma exacerbation between the intervention and control groups at Week 48
Time frame: Week48
Difference in the change in mean ACT score from baseline between the intervention and control groups at Week 48
Time frame: Baseline, week 48
Change in mean ACT score from baseline in the intervention group at Week 24 and 48
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Week 48
The proportion of participants achieved ACT MCID (ACT improvement ≥3 points) in the intervention group at Week 24 and 48
Time frame: 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
Time frame: Week 48
Change in pre-bronchodilator FEV1 (Pre-BD FEV1) from baseline in the intervention group at Week 24 and 48
Time frame: 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
Time frame: Week 48
Difference in St. George's Respiratory Questionnaire (SGRQ) scores (total and domain scores) between the intervention and control groups at Week 48
Time frame: Week 48
Change in SGRQ scores from baseline in the intervention group at Week 24 and Week 48
Time frame: 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
Time frame: Week 48
The proportion of participants achieved SGRQ MCID (decrease in total score ≥4 points) in the intervention group at Week 24 and 48
Time frame: 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
Time frame: Week 48
Difference in the time to written diagnosis of "Severe Asthma" between the intervention and control groups during the 48-week study period;
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Week 48
Difference in the time to first asthma typing record between the intervention and control groups during the 48-week study period
Time frame: 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
Time frame: Week 48
Difference in the time to first eosinophilic asthma phenotype record between the intervention and control groups during the 48-week study period
Time frame: 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
Time frame: 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
Time frame: Week 48
Difference in the cumulative number of pulmonary function test records between the intervention and control groups during the 48-week study period
Time frame: Week 48
Difference in the proportion of participants using biologics between the intervention and control groups during the 48-week study period
Time frame: Week 48
Difference in the duration of biologic use between the intervention and control groups
Time frame: During the 48-week study period
Distribution of different treatment pattern in the intervention group during the 48-week study period
Time frame: During the 48-week study period
Distribution of different treatment pattern in the control group at Week 48
Time frame: 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
Time frame: Week 48
Difference in the drop-out rate between the intervention and control groups at Week 48
Time frame: Week 48
Subgroup analyses will be conducted as appropriate; planned subgroups to explore include: Hospital classification, Participant classification.
Time frame: During the 48-week study period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
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A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-2)
Severe Asthma
RecruitingPhase 2
Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
Asthma
Active, not recruitingPhase 2
A Dose Finding Study With an Anti-TSLP Antibody (GSK5784283) in Adults Aged 18 to 75 Years of Age With Uncontrolled Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
Kewu Huang principal investigator
Beijing Chao Yang Hospital
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Uncontrolled Asthma, run by AstraZeneca at 20 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the proportion of participants with a written diagnosis of "Severe Asthma" between the intervention and control groups at Week 24 (time frame: Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.