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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorPeking University Third Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • not applicable for observational research

    Other intervention

    This is an observational research and has no intervention

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: asthma with frequent exacerbations1 intervention
Group B: asthma without frequent exacerbations1 intervention

Trial outcomes

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

Time frame
baseline and during 1 year follow-up

Secondary outcomes

1

total allergen IgE, allergen-specific IgE,

At baseline, demographic characteristics, asthma severity, asthma control level, comorbidities, lung function, peripheral blood eosinophil count and percentage, FENO, total allergen IgE, allergen-specific IgE, lung CT morphology, and exhaled breath condensate inflammation were collected; total allergen IgE, peripheral blood eosinophil count and percentage, FENO, exhaled breath condensate inflammation, and lung function were followed up at every 3 months; and lung CT morphology was reviewed at 1 year of follow-up; Outdoor environmental pollutants and meteorological information of the place of residence during 1 year of follow-up.

Time frame
baseline and during 1 year follow-up
2

peripheral blood and sputum eosinophil count and percentage

At baseline, demographic characteristics, asthma severity, asthma control level, comorbidities, lung function, peripheral blood eosinophil count and percentage, FENO, total allergen IgE, allergen-specific IgE, lung CT morphology, and exhaled breath condensate inflammation were collected; total allergen IgE, peripheral blood eosinophil count and percentage, FENO, exhaled breath condensate inflammation, and lung function were followed up at every 3 months; and lung CT morphology was reviewed at 1 year of follow-up; Outdoor environmental pollutants and meteorological information of the place of residence during 1 year of follow-up.

Time frame
baseline and during 1 year follow-up
3

lung function

At baseline, demographic characteristics, asthma severity, asthma control level, comorbidities, lung function, peripheral blood eosinophil count and percentage, FENO, total allergen IgE, allergen-specific IgE, lung CT morphology, and exhaled breath condensate inflammation were collected; total allergen IgE, peripheral blood eosinophil count and percentage, FENO, exhaled breath condensate inflammation, and lung function were followed up at every 3 months; and lung CT morphology was reviewed at 1 year of follow-up; Outdoor environmental pollutants and meteorological information of the place of residence during 1 year of follow-up.

Time frame
baseline and during 1 year follow-up
4

lung CT morphology

At baseline, demographic characteristics, asthma severity, asthma control level, comorbidities, lung function, peripheral blood eosinophil count and percentage, FENO, total allergen IgE, allergen-specific IgE, lung CT morphology, and exhaled breath condensate inflammation were collected; total allergen IgE, peripheral blood eosinophil count and percentage, FENO, exhaled breath condensate inflammation, and lung function were followed up at every 3 months; and lung CT morphology was reviewed at 1 year of follow-up; Outdoor environmental pollutants and meteorological information of the place of residence during 1 year of follow-up.

Time frame
baseline and during 1 year follow-up

Other outcomes

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