Retrospective Cohort Study on Asthma With Frequent Acute Attacks Phenotype

Sponsor
Qianfoshan Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06026462
Collaborator
(none)
540
4

Study Details

Study Description

Brief Summary

  1. Identify the risk factors for frequent acute exacerbations of asthma: establish a retrospective study, classify patients into frequent acute exacerbation group and non-frequent acute exacerbation group based on the number of acute exacerbations, analyze the characteristics of the two groups, provide clinical, pathological, and comorbidity features of the frequent acute exacerbation subtype of asthma, determine the risk factors associated with frequent acute exacerbations, and establish a disease prediction model for frequent acute exacerbations of asthma.

  2. Observe the prognosis and treatment outcome of patients with frequent acute exacerbations of asthma, clarify the relevant factors for poor prognosis in this group of patients, and explore individualized treatment plans to improve the prognosis of patients.

  3. Investigate the inflammatory mechanism of frequent acute exacerbations of asthma: use omics methods to screen for subtype-specific biomarkers of frequent acute exacerbations and validate them, clarify the pathogenesis of this subtype, and discover new specific treatment targets.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Observation of clinical indicators related to asthma

Study Design

Study Type:
Observational
Anticipated Enrollment :
540 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
A Retrospective Cohort Study on the Risk Factors and Prognosis of Asthma With Frequent Acute Attacks Phenotype
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Asthma with frequent acute exacerbations phenotype

Diagnostic Test: Observation of clinical indicators related to asthma
Observe the severity of asthma, drug compliance, comorbidities, asthma control, pulmonary function, FeNO, and the number of acute episodes of asthma

Asthma with Intermittent acute exacerbations phenotype

Diagnostic Test: Observation of clinical indicators related to asthma
Observe the severity of asthma, drug compliance, comorbidities, asthma control, pulmonary function, FeNO, and the number of acute episodes of asthma

Outcome Measures

Primary Outcome Measures

  1. Annualized asthma exacerbation rate [one year]

    Annual asthma exacerbation rate is calculated as total number of exacerbations of interest divided by the total time at risk

Secondary Outcome Measures

  1. Post-bronchodilator forced expiratory volume in 1 second [up to one year]

    Lung function will be described.

  2. Median inhaled corticosteroids (ICS) dose change [one year]

    Asthma related ICS use will be described.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Inclusion Criteria:

18-65 years old, taking asthma medication for at least 4 weeks. The diagnostic criteria for asthma are based on the recommendations of the current guidelines (Guidelines for the

Prevention and Treatment of Bronchial Asthma (Version 2020), as follows:
  1. Repeated episodes of wheezing, shortness of breath, chest tightness, or coughing are often associated with exposure to allergens, cold air, physical and chemical stimuli, viral upper respiratory tract infections, and exercise.

  2. During the attack, scattered or diffuse wheezing sounds can be heard in both lungs, mainly in the expiratory phase, and the expiratory phase is prolonged.

  3. The above symptoms and signs can be alleviated by treatment or spontaneously.

  4. Except for wheezing, shortness of breath, chest tightness, and coughing caused by other diseases.

  5. Those with atypical clinical manifestations (such as no obvious wheezing or physical signs) should have at least one positive pulmonary function test as follows: 1. Positive bronchial provocation test or exercise provocation test; The positive FEV1 of bronchodilator test increased by ≥ 12%;, And the absolute value of FEV1 increase ≥ 200ml; 3. Peak expiratory flow (PEF) intraday (or 2-week) variability ≥ 20%.

Asthma can be diagnosed if it meets the criteria of 1-4 or 4-5.

Exclusion Criteria:
  1. Complicated with pneumonia, pulmonary interstitial fibrosis, active pulmonary tuberculosis, obstructive sleep apnea hypopnea syndrome, and other respiratory system related diseases, with a previous history of lung surgery;

  2. Those with the following diseases or conditions: severe, progressive, or uncontrolled cardiovascular, liver, kidney, hematopoietic, and neurological disorders; Malignant tumor; Or the presence of immunosuppression (including the use of immunosuppressants or HIV infection resulting in low immune function);

  3. Accompanied by severe gastrointestinal diseases (such as inflammatory bowel disease [IBD] or irritable bowel syndrome [IBS]), severe diarrhea (watery stools more than 3 times and lasting for more than 3 days) and constipation (less than 2 stools per week and accompanied by difficulty in defecation) in the past 3 weeks;

  4. Systematic application of antibiotics, systemic glucocorticoids (including oral, intravenous [IV] or intramuscular [IM]), microecological agents, or traditional Chinese medicine within the past 4 weeks;

  5. Excessive obesity (BMI>32.0 kg/m2), pregnant and lactating women;

  6. Poor compliance, unable to cooperate with clinical observation and specimen collection.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Qianfoshan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Liang Dong, Clinical Professor, Qianfoshan Hospital
ClinicalTrials.gov Identifier:
NCT06026462
Other Study ID Numbers:
  • 2022-09-21-03
First Posted:
Sep 7, 2023
Last Update Posted:
Sep 7, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 7, 2023