A Cohort Study of Risk Factors and Prognosis for Frequent Acute Asthma Exacerbations Phenotype

NCT06621056 | Recruiting DMC

• 2 other identifiers: M2022148BYSYDL2021020
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Acute asthma exacerbations are an important public health problem and a major cause of disease progression and healthcare burden for people with asthma. Frequent acute exacerbations are likely to be a distinct asthma phenotype. Further research is needed to identify risk factors for frequent acute exacerbations, but previous studies have mostly been cross-sectional studies at a single time point or prospective studies based on smaller sample sizes. Moreover, most of the studies on frequent acute exacerbations have been conducted in severe or refractory asthma, whereas a certain proportion of non-severe asthmatics may also experience frequent acute exacerbations, the risk factors of which remain to be further evaluated. The main objectives of this project are to compare the baseline clinical, inflammatory, pathophysiological, comorbidities, environmental pollutants and meteorological exposure characteristics of patients with frequent acute exacerbations and those with non-frequent acute exacerbations irrespective of asthma severity, and to develop a disease prediction model for frequent acute exacerbations; and to develop a cohort of patients with frequent acute exacerbations of asthma, observe their prognosis and response to treatment, and search for prognostic factors associated with them. The successful implementation of this study will help in the early identification of patients with frequent acute exacerbations, clarify the factors associated with poor prognosis in this group of patients, and thus provide an individualized plan for the treatment and prevention of this type of patients, which is of great significance in achieving good asthma control, reducing the burden of disease, decreasing the cost of healthcare, and saving clinical healthcare resources and costs.

Conditions

Asthma Exacerbations

Keywords

asthma

Outcome Measures

Primary Outcomes (1)

• acute asthma exacerbation

  An acute asthma exacerbation is a condition in which the patient\'s symptoms of wheezing, shortness of breath, chest tightness, and coughing appear in a short period of time or worsen rapidly, and lung function deteriorates, requiring the administration of additional reliever medications for treatment

  baseline and during 1 year follow-up

Secondary Outcomes (4)

• total allergen IgE, allergen-specific IgE,

  baseline and during 1 year follow-up

• peripheral blood and sputum eosinophil count and percentage

  baseline and during 1 year follow-up

• lung function

  baseline and during 1 year follow-up

• lung CT morphology

  baseline and during 1 year follow-up

Study Arms (2)

asthma with frequent exacerbations

asthma with frequent exacerbations

Other: not applicable for observational research

asthma without frequent exacerbations

asthma without frequent exacerbations

Other: not applicable for observational research

Interventions

not applicable for observational research OTHER

This is an observational research and has no intervention

asthma with frequent exacerbations; asthma without frequent exacerbations

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with asthma attending the outpatient clinic of the Department of Respiratory and Critical Care Medicine of Peking University Third Hospital met the diagnostic criteria for asthma proposed by the guidelines for the prevention and treatment of bronchial asthma

You may qualify if:

• Patients with asthma attending the outpatient clinic of the Department of Respiratory and Critical Care Medicine of Peking University Third Hospital met the diagnostic criteria for asthma proposed by the guidelines for the prevention and treatment of bronchial asthma.

You may not qualify if:

• Combination of chronic obstructive pulmonary disease, bronchiectasis, pneumonia, obstructive sleep apnea hypoventilation syndrome, malignancy; combination of various acute and chronic respiratory failure; combination of severe cardiovascular disease; pregnant women.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University third hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Residual blood after testing，sputum

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Chun Chang

CONTACT

19800300860; doudou1977bysy@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: October 1, 2024
• Study Start: January 1, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)