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Not yet recruitingNCT07523724Updated Apr 13, 2026

Screening and Management of Adults With Asthma and Allergic Diseases

An interventional study of Allergen Avoidance Intervention - group 1 and Exercise Intervention - group 1 in Asthma and Allergic Disease, sponsored by Beijing Hospital. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-04-13.

Sponsored by Beijing Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
9,666
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Asthma
  • Allergic Disease

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Keywords

  • Allergic diseases
  • Asthma
  • Questionnaire development and validation
  • Digital health
  • China
03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Aged ≥18 years
  • Capable of providing informed consent and completing the questionnaire independently.

Exclusion criteria

Exclusion Criteria:

  • Individuals with serious chronic diseases, immune disorders, or severe psychiatric/cognitive conditions.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
9,666 participants (estimated)

Study arms

  • Placebo comparator
    Allergen Avoidance Intervention - group 2

    Behavioral: Allergen Avoidance Intervention - group 2

  • Placebo comparator
    Exercise Intervention - group 2

    Behavioral: Exercise Intervention - group 2

  • Placebo comparator
    Dietary Intervention - group 2

    Behavioral: Dietary Intervention - group 2

  • Experimental
    Allergen Avoidance Intervention - group 1

    Behavioral: Allergen Avoidance Intervention - group 1

  • Experimental
    Exercise Intervention - group 1

    Behavioral: Exercise Intervention - group 1

  • Experimental
    Dietary Intervention - group 1

    Behavioral: Dietary Intervention - group 1

Interventions

  • BehavioralAllergen Avoidance Intervention - group 1

    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.

  • BehavioralExercise Intervention - group 1

    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.

  • BehavioralDietary Intervention - group 1

    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.

  • BehavioralAllergen Avoidance Intervention - group 2

    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.

  • BehavioralDietary Intervention - group 2

    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.

  • BehavioralExercise Intervention - group 2

    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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months

  2. 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.

    Time frame: 3 months

Secondary outcomes

  1. Drug usage

    The usage of drugs during the follow-up period

    Time frame: 3 months

  2. 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.

    Time frame: 3 months

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07523724
Lead sponsor
Beijing Hospital
Collaborators
Chinese Academy of Medical Sciences, Jilin University, The First Hospital of Jilin University
Responsible party
Sponsor
First posted
Apr 13, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Dec 30, 2027 (estimated)
Completion
Dec 30, 2027 (estimated)
Last update
Apr 13, 2026

Study contacts

Xunliang Tong, MD
Contact
tongxunliang@163.com
+86 18610021799
Yating Wang
Contact
b2024021020@student.pumc.edu.cn
+86 13521760029

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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