Assessment of Asthma Control Level in Primary Care Setting in Malaysia
ASCOPE
A Prospective Observational Multi Center Study to Assess the Level of Asthma Control at Government Health Clinics (Klinik Kesihatan) in Malaysia.
1 other identifier
observational
1,011
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2017
Shorter than P25 for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 6, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 6, 2018
CompletedFirst Submitted
Initial submission to the registry
January 14, 2019
CompletedFirst Posted
Study publicly available on registry
January 15, 2019
CompletedMay 31, 2019
May 1, 2019
8 months
January 14, 2019
May 30, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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 Arms (1)
GINA-defined clinical diagnosis of Asthma
All patients with GINA-defined clinical diagnosis of Asthma seen at respiratory clinic from October to December 2017 with age 18 and above
Eligibility Criteria
Outpatients seen and treated by health care providers at government health clinics.
You may qualify if:
- 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
You may not qualify if:
- Clinical features suggesting emphysema or chronic bronchitis and other chronic lung diagnosis
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (10)
Research Site
Port Dickson, Negeri Sembilan, Malaysia
Research Site
Seremban, Negeri Sembilan, Malaysia
Research Site
Pantai Remis, Perak, Malaysia
Research Site
George Town, Pulau Pinang, Malaysia
Research Site
Kota Kinabalu, Sabah, Malaysia
Research Site
Asajaya, Sarawak, Malaysia
Research Site
Banting, Selangor, Malaysia
Research Site
Rawang, Selangor, Malaysia
Research Site
Bandar Permaisuri, Terengganu, Malaysia
Research Site
Kuala Terengganu, Terengganu, Malaysia
Related Publications (1)
Mohd Isa NA, Cheng CL, Nasir NH, Naidu V, Gopal VR, Alexander AK. Asthma control and asthma treatment adherence in primary care: results from the prospective, multicentre, non-interventional, observational cohort ASCOPE study in Malaysia. Med J Malaysia. 2020 Jul;75(4):331-337.
PMID: 32723990DERIVED
Related Links
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2019
First Posted
January 15, 2019
Study Start
October 23, 2017
Primary Completion
June 6, 2018
Study Completion
June 6, 2018
Last Updated
May 31, 2019
Record last verified: 2019-05