Identification of Asthma Phenotypes in Severe Asthmatics

Asthma Clinical Trial

Official title:

Identification of Asthma Phenotypes in Severe Asthmatics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01623089
• Other study ID #: 2010/810/C
• Status: Recruiting
• Start date: January 2, 2011
• Est. completion date: January 2026

Study information

• Verified date: July 2021
• Source: Singapore General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 2026
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
Singapore	Singapore General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Annual exacerbation rates	Annual exacerbation rates	Through study completion, an average of 1 year
Primary	Symptom control	Symptom control using Asthma Control Test	Through study completion, an average of 1 year