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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 : July 28, 2021
Information provided by (Responsible Party):
Singapore General Hospital

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

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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Identification of Asthma Phenotypes in Severe Asthmatics
Actual Study Start Date : January 2, 2011
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

severe asthma

Primary Outcome Measures :
  1. Annual exacerbation rates [ Time Frame: Through study completion, an average of 1 year ]
    Annual exacerbation rates

  2. Symptom control [ Time Frame: Through study completion, an average of 1 year ]
    Symptom control using Asthma Control Test

Information from the National Library of Medicine

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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 severe asthma clinic

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.

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

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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
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Principal Investigator: Mariko Koh, MBBS Singapore General Hospital
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Responsible Party: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT01623089    
Other Study ID Numbers: 2010/810/C
First Posted: June 19, 2012    Key Record Dates
Last Update Posted: July 28, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Singapore General Hospital:
severe asthma, phenotype, data
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases