Identification of Asthma Phenotypes in Severe Asthmatics

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by Singapore General Hospital
Sponsor:
Information provided by (Responsible Party):
Mariko Koh, Singapore General Hospital
ClinicalTrials.gov Identifier:
NCT01623089
First received: June 15, 2012
Last updated: June 19, 2012
Last verified: June 2012
  Purpose

Asthma is a heterogenous disease. Different patients have different presentations, course of disease and response to treatment.

The investigators would like to study our population of more severe asthma and find out about their profile - demographic, clinical and inflammatory.


Condition
Asthma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Identification of Asthma Phenotypes in Severe Asthmatics

Resource links provided by NLM:


Further study details as provided by Singapore General Hospital:

Estimated Enrollment: 500
Study Start Date: January 2011
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
severe asthma

Detailed Description:

Asthma is a heterogeneous disorder presenting with many phenotypes. Most asthmatics have mild to moderate disease. However, 5-20% of asthmatics belong to the "Difficult-to-treat" or more severe group and they account for 50-80% of asthma health care costs. In a tertiary hospital like Singapore General Hospital, most of our asthmatics belong to the more severe group. They have more frequent healthcare visits, hospitalizations, medication use and higher risks of death.

There is currently no local data on the phenotypic profile of our patients. Asthma phenotypes which have been identified include those related to triggers ( eg. drugs such as aspirin or NSAIDS, environmental allergen, occupational allergens or irritants, exercise) or clinical physiological phenotypes ( eg. severity-defined, exacerbation-prone, chronic airflow limitation, steroid-resistant, age -of -onset) or inflammatory phenotypes ( eg. eosinophilic, neutrophilic, pauci granulocytic, mixed). With better understanding of their phenotypes, treatment can then be individually tailored to improve their asthma control and reduce future risks.

We aim to improve the understanding of this group of asthmatics such that better treatment approaches can be developed in the future. This is not a clinical trial. Its purpose is to gather information ranging from demographic data, medical history to responses to simple routine questions, to lung function, inflammation, allergy and blood testing results. The data are analyzed to improve our understanding of the clinical and inflammatory phenotypes ( or profiles) in this group of patients.

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Respiratory or asthma clinic

Criteria

Inclusion Criteria:

  1. Difficult-to-treat severe asthma
  2. Treatment-resistant severe asthma patients who are partially or poorly controlled despite high dose inhaled corticosteroids ( ICS) or a high-dose ICS and long acting- beta-2- agonist combination ( LABA) and frequent or chronic use of systemic corticosteroids or
  3. Treatment-resistant severe asthma who are well-controlled on the highest level of recommended treatment to maintain control (high dose ICS or combination of high-dose ICS with other medications such as LABA, theophylline, montelukast, systemic corticosteroids, anti-Ig E, etc.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01623089

Locations
Singapore
Singapore General Hospital Recruiting
Singapore, Singapore, 169608
Contact: Mariko Koh, MBBS    (65) 64699419    mariko.koh.s.y@sgh.com.sg   
Sponsors and Collaborators
Singapore General Hospital
Investigators
Principal Investigator: Mariko Koh, MBBS Singapore General Hospital
  More Information

No publications provided

Responsible Party: Mariko Koh, PI, Singapore General Hospital
ClinicalTrials.gov Identifier: NCT01623089     History of Changes
Other Study ID Numbers: 2010/810/C
Study First Received: June 15, 2012
Last Updated: June 19, 2012
Health Authority: Singapore: Domain Specific Review Boards

Keywords provided by Singapore General Hospital:
severe asthma, phenotype, data

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014