Clinical trial NCT02871947: Epidemiology and Cytokines Analysis of Severe Asthma Patients in Taiwan
Official title: Epidemiology and Cytokines Analysis of Severe Asthma Patients in Taiwan
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bronchial Asthma
Cytokines
Keywords: severe asthma
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2016-08-18
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: severe asthma patients who have received high-dose ICS and still being not well controlled

Brief summary: Severe asthma is a heterogeneous disease characterized by the need for treatment with high doses of inhaled corticosteroids. It affects 5%-10% of asthmatic patients, although it accounts for a significant percentage of the consumption of health care resources. Severe asthma comprises various clinical and pathophysiological phenotypes. In this current study, we aimed to clinical characteristics and cytokes profile in severe asthma patients.

Detailed description: To investigate the clinical phenotypes and inflammatory endotype by analyzing cytokines in severe asthma patients, it may improve characterization of the disease and contribute to improved selection of appropriate treatment. It could also help link genotypes with their phenotypic manifestations and their natural history and prognosis. A greater understanding of the phenotypes of severe asthma could enable identification of biomarkers for each phenotype, and identify the association between biokarkers and clinical outcomes in severe asthma patients.

Eligibility criteria: Inclusion Criteria:

1. Asthma which requires treatment with guidelines suggested medications for GINA steps 4-5 asthma (high dose ICS and LABA or leukotriene modifier/theophylline) for the previous year or systemic CS for 50% of the previous year to prevent it from becoming ''uncontrolled'' or which remains ''uncontrolled'' despite this therapy
2. Uncontrolled asthma defined as at least one of the following:

(1). Poor symptom control: ACQ consistently\>1.5, ACT\<20 (or ''not well controlled'' by NAEPP/GINA guidelines) (2). Frequent severe exacerbations: two or more bursts of systemic CS (\>3 days each) in the previous year (3). Serious exacerbations: at least one hospitalization, ICU stay or mechanical ventilation in the previous year (4). Airflow limitation: after appropriate bronchodilator withhold FEV1\<80% predicted (in the face of reduced FEV1/FVC defined as less than the lower limit of normal)

Exclusion Criteria:

* (1). mild to moderate persistent asthma (2). COPD or other lung diseases (3). malignancy (4). long-term O2 therapy more than 15 hours/day (5). long-term NIPPV use (\> 6 hours/day) (6). no inform consent and cannot be followed regularly (7). active TB or other infection diseases

Primary outcomes:
measure: asthma acute exacerbation
timeFrame: 1 year follow-up
Secondary outcomes:
measure: inflammatory biomarkers
timeFrame: 1, 3, 6, 9. 12 months
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: Chest department, Veteran General Hospital-TAIPEI
city: Taipei
country: Taiwan
facility: Taipei Veterans Genral Hospital
Study officials:
References: