Retrospective Cohort Study on Asthma With Frequent Acute Attacks Phenotype
NCT ID: NCT06026462
Last Updated: 2023-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
540 participants
OBSERVATIONAL
2024-01-01
2024-07-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Asthma with frequent acute exacerbations phenotype
Asthma with frequent acute exacerbations phenotype was defined as having at least two acute attacks in the past 12 months.
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
Asthma with Intermittent acute exacerbations phenotype was defined as having less than or equal to one acute attacks in the past 12 months.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
60 Years
ALL
No
Sponsors
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Qianfoshan Hospital
OTHER
Responsible Party
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Liang Dong
Clinical Professor
Principal Investigators
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Liang Dong, PHD
Role: PRINCIPAL_INVESTIGATOR
Department of Respiratory and Critical Care Medicine, Shandong Provincial Qianfoshan Hospital
Central Contacts
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Other Identifiers
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2022-09-21-03
Identifier Type: -
Identifier Source: org_study_id