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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
Sponsor:
Information provided by (Responsible Party):
Singapore General Hospital

Tracking Information
First Submitted Date June 15, 2012
First Posted Date June 19, 2012
Last Update Posted Date July 28, 2021
Actual Study Start Date January 2, 2011
Estimated Primary Completion Date January 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 22, 2021)
  • Annual exacerbation rates [ Time Frame: Through study completion, an average of 1 year ]
    Annual exacerbation rates
  • Symptom control [ Time Frame: Through study completion, an average of 1 year ]
    Symptom control using Asthma Control Test
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Identification of Asthma Phenotypes in Severe Asthmatics
Official Title Identification of Asthma Phenotypes in Severe Asthmatics
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.

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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Respiratory or severe asthma clinic
Condition Asthma
Intervention Not Provided
Study Groups/Cohorts severe asthma
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 22, 2021)
1000
Original Estimated Enrollment
 (submitted: June 18, 2012)
500
Estimated Study Completion Date January 2026
Estimated Primary Completion Date January 2025   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries Singapore
Removed Location Countries  
 
Administrative Information
NCT Number NCT01623089
Other Study ID Numbers 2010/810/C
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Singapore General Hospital
Original Responsible Party Mariko Koh, Singapore General Hospital, PI
Current Study Sponsor Singapore General Hospital
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Mariko Koh, MBBS Singapore General Hospital
PRS Account Singapore General Hospital
Verification Date July 2021