NCT01623089

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2011

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 19, 2012

Completed
12.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

July 28, 2021

Status Verified

July 1, 2021

Enrollment Period

14 years

First QC Date

June 15, 2012

Last Update Submit

July 22, 2021

Conditions

Asthma

Keywords

severe asthma, phenotype, data

Outcome Measures

Primary Outcomes (2)

  • Annual exacerbation rates

    Annual exacerbation rates

    Through study completion, an average of 1 year

  • Symptom control

    Symptom control using Asthma Control Test

    Through study completion, an average of 1 year

Study Arms (1)

severe asthma

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Respiratory or severe asthma clinic

You may qualify if:

  • Difficult-to-treat severe asthma
  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore General Hospital

Singapore, 169608, Singapore

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Mariko Koh, MBBS

    Singapore General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2012

First Posted

June 19, 2012

Study Start

January 2, 2011

Primary Completion

January 1, 2025

Study Completion

January 1, 2026

Last Updated

July 28, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)