Epidemiology and Cytokines Analysis of Severe Asthma Patients in Taiwan

NCT02871947 | Unknown

• 1 other identifier: 2016-03-010AC
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 2

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.

Conditions

Bronchial Asthma; Cytokines

Keywords

severe asthma

Outcome Measures

Primary Outcomes (1)

• asthma acute exacerbation

  1 year follow-up

Secondary Outcomes (1)

• inflammatory biomarkers

  1, 3, 6, 9. 12 months

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

severe asthma patients who have received high-dose ICS and still being not well controlled

You may qualify if:

• 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
• 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)

You may not qualify if:

• (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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (2)

Taipei Veterans Genral Hospital

Taipei, Taiwan, 111, Taiwan

RECRUITING

Chest department, Veteran General Hospital-TAIPEI

Taipei, Taiwan, 112, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Diahn-Warng Perng, Department of Chest Medicine

Study Record Dates

• First Submitted: August 16, 2016
• First Posted: August 18, 2016
• Study Start: March 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: September 1, 2017
• Last Updated: August 18, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)