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Epidemiology and Cytokines Analysis of Severe Asthma Patients in Taiwan

Sponsor
Taipei Veterans General Hospital, Taiwan (Other)
Overall Status
Unknown status
CT.gov ID
NCT02871947
Collaborator
(none)
70
Enrollment
2
Locations
18
Duration (Months)
35
Patients Per Site
1.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    70 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Epidemiology and Cytokines Analysis of Severe Asthma Patients in Taiwan
    Study Start Date :
    Mar 1, 2016
    Anticipated Primary Completion Date :
    Feb 1, 2017
    Anticipated Study Completion Date :
    Sep 1, 2017

    Outcome Measures

    Primary Outcome Measures

    1. asthma acute exacerbation [1 year follow-up]

    Secondary Outcome Measures

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

      IgE and Eosphile count

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chest department, Veteran General Hospital-TAIPEI Taipei City Taiwan 112
    2 Taipei Veterans Genral Hospital Taipei Taiwan 111

    Sponsors and Collaborators

    • Taipei Veterans General Hospital, Taiwan

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    vghtpe user, Diahn-Warng Perng, Department of Chest Medicine, Taipei Veterans General Hospital, Taiwan
    ClinicalTrials.gov Identifier:
    NCT02871947
    Other Study ID Numbers:
    • 2016-03-010AC
    First Posted:
    Aug 18, 2016
    Last Update Posted:
    Aug 18, 2016
    Last Verified:
    Mar 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by vghtpe user, Diahn-Warng Perng, Department of Chest Medicine, Taipei Veterans General Hospital, Taiwan
    severe asthma
    Additional relevant MeSH terms:
    Asthma

    Study Results

    No Results Posted as of Aug 18, 2016