AsthmaNCT07523724
Screening and Management of Adults With Asthma and Allergic Diseases
A study testing Allergen Avoidance Intervention - group 1, Exercise Intervention - group 1 and Dietary Intervention - group 1 in people with Asthma and Allergic Disease, run by Beijing Hospital.
Trial summary
The aim of this study is to develop and validate a digital screening tool and digital management system for asthma and allergic diseases among Chinese adults and to evaluate the effectiveness of integrated non-pharmacological interventions in improving disease control and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Asthma, Allergic Disease
- What is being tested?
- Allergen Avoidance Intervention - group 1, Exercise Intervention - group 1 and Dietary Intervention - group 1
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9,666 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 30 Dec 2027
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged ≥18 years
- Capable of providing informed consent and completing the questionnaire independently.
Who cannot join
- Individuals with serious chronic diseases, immune disorders, or severe psychiatric/cognitive conditions.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The aim of this study is to develop and validate a digital screening tool and digital management system for asthma and allergic diseases among Chinese adults and to evaluate the effectiveness of integrated non-pharmacological interventions in improving disease control and quality of life.
The digital management cohort consists of:
- At least 12 months of longitudinal monitoring of symptoms, environmental exposures, and health behaviors via a digital platform, supplemented by regular clinical assessments.
- 3x embedded randomized controlled trials (RCTs) evaluating the clinical efficacy of non-pharmacological strategies: allergen avoidance (anti-mite bedding), physical activity (wearable-guided exercise), and dietary management (Mediterranean diet).
Read the detailed description
Early identification and sustained management are crucial for mitigating the growing public health burden of asthma and allergic diseases. This study implements a coherent system spanning from population-level assessment to individualized, long-term care. The primary objectives are to:
Validate a culturally adapted screening questionnaire and an integrated digital health platform for the Chinese population.
Establish a prospective longitudinal cohort to investigate disease progression and evaluate the clinical efficacy of non-pharmacological interventions via embedded randomized controlled trials (RCTs).
The investigators will enroll approximately 9,666 first-year university students into a hybrid study that combines a digital cohort with targeted intervention trials. Following initial tool validation, large-scale screening will be conducted during entrance health check-ups. Individuals identified through screening or with self-reported allergic conditions will be invited to join a longitudinal management cohort for at least one year of follow-up.
Within this monitoring framework, eligible participants will be recruited into three distinct embedded RCTs evaluating non-pharmacological strategies:
- Allergen Avoidance: Evaluating the impact of weekly anti-mite bedding replacement and HEPA vacuuming.
- Exercise Intervention: An 8-week behavioral program using wearable activity trackers to improve outcomes for sedentary adults with asthma.
- Dietary Intervention: A 12-week study assessing the effects of a Mediterranean diet on asthma control.
Longitudinal follow-up utilizes a mixed-methods strategy, integrating passive self-reporting every 3 months via the digital platform with active researcher-led assessments every 6 months, including clinical laboratory testing (IgE, FeNO) and spirometry. This approach allows for the investigation of complex interactions between genetic susceptibility and environmental exposures in disease expression.
- Conditions
- Asthma, Allergic Disease
- Being tested
- Allergen Avoidance Intervention - group 1, Exercise Intervention - group 1, Dietary Intervention - group 1, Allergen Avoidance Intervention - group 2, Dietary Intervention - group 2
- Keywords
- Allergic diseases, Asthma, Questionnaire development and validation, Digital health, China
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allergen Avoidance Intervention - group 1Behavioural
Participants received standardized allergen avoidance measures, with the primary goal of reducing allergen exposure levels. Specific measures included regularly implementing allergen avoidance behaviors and recording environmental parameters. The operational details were carried out in accordance with the research protocol. During the intervention period, the original medication treatment was maintained.
Exercise Intervention - group 1Behavioural
Participants receive a standardized exercise promotion program, which included, but is not limited to, regular face-to-face guidance, motivational interviews, personalized goal setting, action planning, and self-feedback and adjustment based on objective activity monitoring data. During the intervention period, the subjects maintain their original medication treatment plans unchanged.
Dietary Intervention - group 1Behavioural
Participants receive standardized guidance on a healthy diet pattern. The intervention measures included, but are not limited to, guidance from nutritionists, provision of food materials, and monitoring of dietary compliance. During the intervention period, the subjects maintain their original medication treatment plans unchanged.
Allergen Avoidance Intervention - group 2Behavioural
Participants eceive usual care, consisting of standard pharmacological treatment. They are instructed to maintain their baseline lifestyle and activity levels without participating in additional allergen avoidance interventions.
Dietary Intervention - group 2Behavioural
Participants continue their routine clinical treatment and do not receive dietary interventions. At baseline, all participants watch a 10-minute asthma self-management education video that does not contain dietary advice.
Exercise Intervention - group 2Behavioural
Participants receive usual care, consisting of standard pharmacological treatment. They are instructed to maintain their baseline lifestyle and activity levels without participating in additional exercise interventions.
| Study group | Role | What they receive |
|---|---|---|
| Allergen Avoidance Intervention - group 2 | Placebo comparator | Not described Receives: Behavioral: Allergen Avoidance Intervention - group 2 |
| Exercise Intervention - group 2 | Placebo comparator | Not described Receives: Behavioral: Exercise Intervention - group 2 |
| Dietary Intervention - group 2 | Placebo comparator | Not described Receives: Behavioral: Dietary Intervention - group 2 |
| Allergen Avoidance Intervention - group 1 | Experimental | Not described Receives: Behavioral: Allergen Avoidance Intervention - group 1 |
| Exercise Intervention - group 1 | Experimental | Not described Receives: Behavioral: Exercise Intervention - group 1 |
| Dietary Intervention - group 1 | Experimental | Not described Receives: Behavioral: Dietary Intervention - group 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Control Test
Patient health-related outcomes, specifically the level of asthma control, were measured using the pre-validated Asthma Control Test (ACT). This tool consists of 5 questions, each scored on a scale from 1 to 5. A total score of 19 or less indicates that the patient's asthma may not be well-controlled, signaling a need for clinical re-evaluation and potential adjustments to their treatment regimen. A score of 15 or less suggests that the asthma is poorly controlled or completely uncontrolled.
Measured: 3 months
Quality of life score
Change in Asthma Quality of Life Questionnaire score in the intervention group. Values range 7-224, with higher scores indicating better quality of life.
Measured: 3 months
Secondary outcomes (2)
Drug usage
The usage of drugs during the follow-up period
Measured: 3 months
Acute asthma exacerbation
An acute asthma exacerbation is characterized by a rapid onset or progressive worsening of symptoms-including wheezing, dyspnea, chest tightness, and coughing-accompanied by a decline in lung function.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 randomised controlled trials (RCTs), embedded within the cohort study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 9,666 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Hospital
- Sponsor type
- Other government
- Collaborators
- Chinese Academy of Medical Sciences, Jilin University, The First Hospital of Jilin University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07523724
- Sponsor's protocol ID
- CAMS&PUMC-IEC-2025-040
- Status last verified
- Mar 2026
- First submitted
- 6 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening and Management of Adults With Asthma and Allergic Diseases
- ClinicalTrials.gov ID
- NCT07523724
- Acronym / sponsor ID
- CAMS&PUMC-IEC-2025-040
- Conditions
- Asthma, Allergic Disease
- Keywords
- Allergic diseases, Asthma, Questionnaire development and validation, Digital health, China
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 9,666 participants (estimated)
- Lead sponsor
- Beijing HospitalOther government
- Collaborators
- Chinese Academy of Medical Sciences, Jilin University, The First Hospital of Jilin University
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 13 Apr 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 aim of this study is to develop and validate a digital screening tool and digital management system for asthma and allergic diseases among Chinese adults and to evaluate the effectiveness of integrated non-pharmacological interventions in improving disease control and quality of life.
The digital management cohort consists of:
- At least 12 months of longitudinal monitoring of symptoms, environmental exposures, and health behaviors via a digital platform, supplemented by regular clinical assessments.
- 3x embedded randomized controlled trials (RCTs) evaluating the clinical efficacy of non-pharmacological strategies: allergen avoidance (anti-mite bedding), physical activity (wearable-guided exercise), and dietary management (Mediterranean diet).
Detailed description
Early identification and sustained management are crucial for mitigating the growing public health burden of asthma and allergic diseases. This study implements a coherent system spanning from population-level assessment to individualized, long-term care. The primary objectives are to:
Validate a culturally adapted screening questionnaire and an integrated digital health platform for the Chinese population.
Establish a prospective longitudinal cohort to investigate disease progression and evaluate the clinical efficacy of non-pharmacological interventions via embedded randomized controlled trials (RCTs).
The investigators will enroll approximately 9,666 first-year university students into a hybrid study that combines a digital cohort with targeted intervention trials. Following initial tool validation, large-scale screening will be conducted during entrance health check-ups. Individuals identified through screening or with self-reported allergic conditions will be invited to join a longitudinal management cohort for at least one year of follow-up.
Within this monitoring framework, eligible participants will be recruited into three distinct embedded RCTs evaluating non-pharmacological strategies:
- Allergen Avoidance: Evaluating the impact of weekly anti-mite bedding replacement and HEPA vacuuming.
- Exercise Intervention: An 8-week behavioral program using wearable activity trackers to improve outcomes for sedentary adults with asthma.
- Dietary Intervention: A 12-week study assessing the effects of a Mediterranean diet on asthma control.
Longitudinal follow-up utilizes a mixed-methods strategy, integrating passive self-reporting every 3 months via the digital platform with active researcher-led assessments every 6 months, including clinical laboratory testing (IgE, FeNO) and spirometry. This approach allows for the investigation of complex interactions between genetic susceptibility and environmental exposures in disease expression.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
- Model description
- 3 randomised controlled trials (RCTs), embedded within the cohort study.
| Arm | Type | Receives |
|---|---|---|
| Allergen Avoidance Intervention - group 2 | Placebo comparator | Behavioral: Allergen Avoidance Intervention - group 2 |
| Exercise Intervention - group 2 | Placebo comparator | Behavioral: Exercise Intervention - group 2 |
| Dietary Intervention - group 2 | Placebo comparator | Behavioral: Dietary Intervention - group 2 |
| Allergen Avoidance Intervention - group 1 | Experimental | Behavioral: Allergen Avoidance Intervention - group 1 |
| Exercise Intervention - group 1 | Experimental | Behavioral: Exercise Intervention - group 1 |
| Dietary Intervention - group 1 | Experimental | Behavioral: Dietary Intervention - group 1 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Aged ≥18 years
- Capable of providing informed consent and completing the questionnaire independently.
Key exclusion criteria (1 listed)
- Individuals with serious chronic diseases, immune disorders, or severe psychiatric/cognitive conditions.
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 |
|---|---|---|
| Allergen Avoidance Intervention - group 1Participants received standardized allergen avoidance measures, with the primary goal of reducing allergen exposure levels. Specific measures included regularly implementing allergen avoidance behaviors and recording environmental parameters. The operational details were carried out in accordance with the research protocol. During the intervention period, the original medication treatment was maintained. | Behavioural | Allergen Avoidance Intervention - group 1 |
| Exercise Intervention - group 1Participants receive a standardized exercise promotion program, which included, but is not limited to, regular face-to-face guidance, motivational interviews, personalized goal setting, action planning, and self-feedback and adjustment based on objective activity monitoring data. During the intervention period, the subjects maintain their original medication treatment plans unchanged. | Behavioural | Exercise Intervention - group 1 |
| Dietary Intervention - group 1Participants receive standardized guidance on a healthy diet pattern. The intervention measures included, but are not limited to, guidance from nutritionists, provision of food materials, and monitoring of dietary compliance. During the intervention period, the subjects maintain their original medication treatment plans unchanged. | Behavioural | Dietary Intervention - group 1 |
| Allergen Avoidance Intervention - group 2Participants eceive usual care, consisting of standard pharmacological treatment. They are instructed to maintain their baseline lifestyle and activity levels without participating in additional allergen avoidance interventions. | Behavioural | Allergen Avoidance Intervention - group 2 |
| Dietary Intervention - group 2Participants continue their routine clinical treatment and do not receive dietary interventions. At baseline, all participants watch a 10-minute asthma self-management education video that does not contain dietary advice. | Behavioural | Dietary Intervention - group 2 |
| Exercise Intervention - group 2Participants receive usual care, consisting of standard pharmacological treatment. They are instructed to maintain their baseline lifestyle and activity levels without participating in additional exercise interventions. | Behavioural | Exercise Intervention - group 2 |
Primary outcome
Asthma Control Test
Time frame: 3 months
Patient health-related outcomes, specifically the level of asthma control, were measured using the pre-validated Asthma Control Test (ACT). This tool consists of 5 questions, each scored on a scale from 1 to 5. A total score of 19 or less indicates that the patient's asthma may not be well-controlled, signaling a need for clinical re-evaluation and potential adjustments to their treatment regimen. A score of 15 or less suggests that the asthma is poorly controlled or completely uncontrolled.
Quality of life score
Time frame: 3 months
Change in Asthma Quality of Life Questionnaire score in the intervention group. Values range 7-224, with higher scores indicating better quality of life.
2 secondary outcomes
Drug usage
Time frame: 3 months
Acute asthma exacerbation
Time frame: 3 months
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 13 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Allergen Avoidance Intervention - group 1, Exercise Intervention - group 1 and Dietary Intervention - group 1 in people with Asthma and Allergic Disease, run by Beijing Hospital.
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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Xunliang Tong, MD (+86 18610021799, tongxunliang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma Control Test (time frame: 3 months). 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 13 Apr 2026.