Assessment of Asthma Control Level in Malaysia (ASCORE)

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

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

Study Overview

• Status: Completed
• Conditions: Asthma Control Level

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 Type: Observational
• Enrollment (Actual): 398

Contacts and Locations

Study Locations

• Malaysia
  • Selangor
    • Kajang, Selangor, Malaysia
      • Hospital Serdang
  • Wilayah Persekutuan Kuala Lumpur
    • Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia
      • Institut Perubatan Respiratori

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Tertiary Care Centre ( patients seen at outpatient physicians )

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

Helpful Links

• CSR Synopsis

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 3, 2017
• Primary Completion (ACTUAL): April 5, 2017
• Study Completion (ACTUAL): April 5, 2017

Study Registration Dates

• First Submitted: August 29, 2017
• First Submitted That Met QC Criteria: September 21, 2017
• First Posted (ACTUAL): September 27, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 11, 2018
• Last Update Submitted That Met QC Criteria: May 7, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: D2287R00116

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: N/A, Non interventional Study , observational study. No patient involved

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No