Skip to main content
Clinical Trials/NCT03804632
NCT03804632
Completed
Not Applicable

A Prospective Observational Multi Center Study to Assess the Level of Asthma Control at Government Health Clinics (Klinik Kesihatan) in Malaysia.

AstraZeneca1 site in 1 country1,011 target enrollmentOctober 23, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Asthma Control Level
Sponsor
AstraZeneca
Enrollment
1011
Locations
1
Primary Endpoint
Level of GINA-defined asthma control
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

A prospective observational multi center study to assess the level of asthma control at Primary Care Setting; government health clinics (Klinik Kesihatan) in Malaysia. The specific objective of the study is to assess, in real-life clinical practice in Malaysia, the level of asthma control and the potential risk factors for uncontrolled disease in asthma patients treated at government health clinics.

Detailed Description

Despite the availability of GINA global guideline on asthma management which is widely referred by health care providers in Malaysia, the control of asthma is still a critical challenge. According to National Health and Morbidity Survey 2011, the prevalence of asthma in Malaysia is at 6.3%. Based on self-rated health status, 5.5% of patients were reported to be in good health whereas 9.9% reported poor health status although medications such as inhaled corticosteroids (ICS) and long-acting beta agonists (LABA) are widely available for effective asthma management. There is limited data to assess the level of asthma control at the Primary Care Setting in Malaysia which includes current clinical manifestation and future risk of exacerbation. Given the lack of data on Asthma control level, the awareness on the current disease control level will assist to properly characterise the patients based on GINA control level thus leading to appropriate diagnosis and treatment. 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.

Registry
clinicaltrials.gov
Start Date
October 23, 2017
End Date
June 6, 2018
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Malaysians who have been diagnosed with Asthma by a physician verified by an investigator and seen at government health clinic (Klinik Kesihatan) from October - December 2017
  • Be at least 18 years of age

Exclusion Criteria

  • Clinical features suggesting emphysema or chronic bronchitis and other chronic lung diagnosis
  • Pregnancy

Outcomes

Primary Outcomes

Level of GINA-defined asthma control

Time Frame: up to 8 months

GINA-defined asthma control: According to clinical characteristics that include daytime symptoms, limitations of activity, nocturnal symptoms/awakening, need for reliever/rescue treatment. Patient's are classified as controlled, partially controlled or uncontrolled.

Secondary Outcomes

  • Types of medication prescribed for asthma control(up to 8 months)
  • Asthma control level(up to 8 months)
  • Adherence level in patients with inhalers(up to 8 months)

Study Sites (1)

Loading locations...

Similar Trials