Assessment of Asthma Control Level in Malaysia

Asthma Control Level Clinical Trial

— ASCORE  

Official title:

A Non-Interventional Retrospective Study To Assess The Level Of Asthma Control Among Adults at 2 Tertiary Care Centres In Malaysia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03295331
• Other study ID #: D2287R00116
• Status: Completed
• Start date: January 3, 2017
• Est. completion date: April 5, 2017

Study information

• Verified date: May 2018
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 398
• Est. completion date: April 5, 2017
• Est. primary completion date: April 5, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthma Control Level

Locations

Country	Name	City	State
Malaysia	Hospital Serdang	Kajang	Selangor
Malaysia	Institut Perubatan Respiratori	Kuala Lumpur	Wilayah Persekutuan Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Types of medication prescribed for asthma control	Pharmacological management used for asthma control	up to 8 months
Secondary	Asthma control level	Asthma control level measured by Asthma Control Test (ACT) score	up to 8 months

External Links

•   CSR Synopsis