Epidemiology and Cytokines Analysis of Severe Asthma Patients in Taiwan

Bronchial Asthma Clinical Trial

Official title:

Epidemiology and Cytokines Analysis of Severe Asthma Patients in Taiwan

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02871947
• Other study ID #: 2016-03-010AC
• Status: Recruiting
• Phase: N/A
• First received: August 16, 2016
• Last updated: August 16, 2016
• Start date: March 2016
• Est. completion date: September 2017

Study information

• Verified date: March 2016
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: September 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma
• Bronchial Asthma
• Cytokines

Locations

Country	Name	City	State
Taiwan	Taipei Veterans Genral Hospital	Taipei
Taiwan	Chest department, Veteran General Hospital-TAIPEI	Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	asthma acute exacerbation		1 year follow-up	No
Secondary	inflammatory biomarkers	IgE and Eosphile count	1, 3, 6, 9. 12 months	No