NCT03295331

Brief Summary

A Non-Interventional Retrospective Study To Assess The Level Of Asthma Control Among Adults at 2 Tertiary Care Centres In Malaysia; Institute Of Respiratory Medicine (IPR) And Hospital Serdang. The specific objective of the study is to assess, in real-life clinical practice in Malaysia, the level of GINA-defined asthma control and the potential risk factors for uncontrolled disease in asthma patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
398

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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 3, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2017

Completed
29 days until next milestone

First Posted

Study publicly available on registry

September 27, 2017

Completed
Last Updated

May 11, 2018

Status Verified

May 1, 2018

Enrollment Period

3 months

First QC Date

August 29, 2017

Last Update Submit

May 7, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Level of GINA-defined asthma control

    To assess, in real-life clinical practice in Malaysia, the level of GINA-defined asthma control and the potential risk factors for uncontrolled disease in asthma patients

    up to 8 months

Secondary Outcomes (2)

  • Types of medication prescribed for asthma control

    up to 8 months

  • Asthma control level

    up to 8 months

Study Arms (1)

GINA-defined clinical diagnosis of Asthma

All patients with GINA-defined clinical diagnosis of Asthma seen at respiratory clinic from January to August 2016 with age 18 and above

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Tertiary Care Centre ( patients seen at outpatient physicians )

You may qualify if:

  • All patients with GINA-defined clinical diagnosis of Asthma seen at respiratory clinic from January to August 2016.
  • Be at least 18 years of age

You may not qualify if:

  • Clinical features suggesting emphysema or chronic bronchitis
  • Other de-compensated organ failures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institut Perubatan Respiratori

Kuala Lumpur, Kuala Lumpur, Malaysia

Location

Hospital Serdang

Kajang, Selangor, Malaysia

Location

Related Links

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2017

First Posted

September 27, 2017

Study Start

January 3, 2017

Primary Completion

April 5, 2017

Study Completion

April 5, 2017

Last Updated

May 11, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

N/A, Non interventional Study , observational study. No patient involved

Locations