Assessment of Asthma Control Level in Malaysia

Completed

• Conditions: Asthma Control Level

• Registration Number: NCT03295331
• Lead Sponsor: AstraZeneca

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

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 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

Study Timeline

• Study Start: 2017-01-03
• Primary Completion: 2017-04-05
• Study Completion: 2017-04-05
• Study First Submitted: 2017-08-29
• Study First Submitted QC: 2017-09-21
• Study First Posted: 2017-09-27
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-07
• Last Update Posted: 2018-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 398

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Level of GINA-defined asthma control	up to 8 months	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

Secondary Outcome Measures

Name	Time	Method
Types of medication prescribed for asthma control	up to 8 months	Pharmacological management used for asthma control
Asthma control level	up to 8 months	Asthma control level measured by Asthma Control Test (ACT) score

Trial Locations

Locations (2)

Hospital Serdang; 🇲🇾 Kajang, Selangor, Malaysia

Institut Perubatan Respiratori; 🇲🇾 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia