Epidemiology and Cytokines Analysis of Severe Asthma Patients in Taiwan

• Register: ClinicalTrials.gov
• Last refreshed on: 29 August 2016
• Main ID: NCT02871947
• Date of registration: 16/08/2016
• Prospective Registration: No
• Primary sponsor: Taipei Veterans General Hospital, Taiwan
• Public title: Epidemiology and Cytokines Analysis of Severe Asthma Patients in Taiwan
• Scientific title: Epidemiology and Cytokines Analysis of Severe Asthma Patients in Taiwan
• Date of first enrolment: March 2016
• Target sample size: 70
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02871947
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

Taiwan

Key inclusion & exclusion 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



Age minimum: 20 Years
Age maximum: 90 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Bronchial Asthma

Cytokines

Primary Outcome(s)

asthma acute exacerbation [Time Frame: 1 year follow-up]

Secondary Outcome(s)

inflammatory biomarkers [Time Frame: 1, 3, 6, 9. 12 months]

Secondary ID(s)

2016-03-010AC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors