Assessment of Asthma Control Level in Primary Care Setting in Malaysia

Asthma Control Level Clinical Trial

— ASCOPE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03804632
• Other study ID #: D2287R00120
• Status: Completed
• Start date: October 23, 2017
• Est. completion date: June 6, 2018

Study information

• Verified date: May 2019
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1011
• Est. completion date: June 6, 2018
• Est. primary completion date: June 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthma Control Level

Locations

Country	Name	City	State
Malaysia	Research Site	Asajaya	Sarawak
Malaysia	Research Site	Bandar Permaisuri	Terengganu
Malaysia	Research Site	Banting	Selangor
Malaysia	Research Site	George Town	Penang
Malaysia	Research Site	Kota Kinabalu	Sabah
Malaysia	Research Site	Kuala Terengganu	Terengganu
Malaysia	Research Site	Pantai Remis	Perak
Malaysia	Research Site	Port Dickson	Negeri Sembilan
Malaysia	Research Site	Rawang	Selangor
Malaysia	Research Site	Seremban	Negeri Sembilan

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	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.	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 is evaluated by patients' self-completion of the Asthma Control Test (ACT). The ACT is a reliable, valid tool that helps physicians identify patients with uncontrolled asthma in a clinical setting. The questionnaire assesses the frequency of asthma symptoms and patients' own perception of asthma control during the previous 4 weeks. Based on the sum of scores, complete asthma control (25 points), well-controlled asthma (20-24 points) or no asthma control (=19 points) is revealed.	up to 8 months
Secondary	Adherence level in patients with inhalers	Adherence level measured by Malaysia Medication Adherence Scale (MALMAS); The first item of the MALMAS has five responses: (1) All the time, (2) Often, (3) Sometimes, (4) Rarely and (5) Never.; The remaining seven items have a dichotomous response of "Yes" or "No". The responses in the MALMAS were scored based on the MMAS-8 where the total score ranged from 0 to 8. Both instruments categorized medication adherence based on the total scores obtained: low adherence (total score<6), medium adherence (6 to < 8) and high adherence (total score = 8)	up to 8 months

External Links

•   CSR Synopsis