Retrospective Cohort Study on Asthma With Frequent Acute Attacks Phenotype

A Retrospective Cohort Study on the Risk Factors and Prognosis of Asthma With Frequent Acute Attacks Phenotype

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Asthma
• Intervention / Treatment: Diagnostic test: Observation of clinical indicators related to asthma

• Study Type: Observational
• Enrollment (Estimated): 540

Contacts and Locations

• Study Contact: Name: Jintao Zhang, PHD; Phone Number: 17853138213; Email: zjt9607@126.com
• Study Contact Backup: Name: Fen Liu, PHD; Phone Number: 13589125462; Email: liufen0102@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Asthma patients who continuously visit our hospital

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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; Asthma with Intermittent acute exacerbations phenotype was defined as having less than or equal to one acute attacks in the past 12 months.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annualized asthma exacerbation rate	Annual asthma exacerbation rate is calculated as total number of exacerbations of interest divided by the total time at risk	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-bronchodilator forced expiratory volume in 1 second	Lung function will be described.	up to one year
Median inhaled corticosteroids (ICS) dose change	Asthma related ICS use will be described.	one year

Collaborators and Investigators

• Sponsor: Qianfoshan Hospital
• Investigators: Principal Investigator: Liang Dong, PHD, Department of Respiratory and Critical Care Medicine, Shandong Provincial Qianfoshan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: March 28, 2023
• First Submitted That Met QC Criteria: September 6, 2023
• First Posted (Actual): September 7, 2023

Study Record Updates

• Last Update Posted (Actual): December 28, 2023
• Last Update Submitted That Met QC Criteria: December 26, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 2022-09-21-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No