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Identification of Asthma Phenotypes in Severe Asthmatics

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ClinicalTrials.gov Identifier: NCT01623089
Recruitment Status : Recruiting
First Posted : June 19, 2012
Last Update Posted : February 10, 2017
Sponsor:
Information provided by (Responsible Party):
Singapore General Hospital

Study Description
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Brief Summary:

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 or disease
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.


Study Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Identification of Asthma Phenotypes in Severe Asthmatics
Study Start Date : January 2011
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Groups and Cohorts
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Group/Cohort
severe asthma


Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Responsible Party: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT01623089     History of Changes
Other Study ID Numbers: 2010/810/C
First Posted: June 19, 2012    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017

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