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Assessment of Asthma Control Level in Primary Care Setting in Malaysia

NCT ID: NCT03804632

Last Updated: 2019-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1011 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-23

Study Completion Date

2018-06-06

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Asthma Control Level

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Port Dickson, Negeri Sembilan, Malaysia

Site Status

Research Site

Seremban, Negeri Sembilan, Malaysia

Site Status

Research Site

Pantai Remis, Perak, Malaysia

Site Status

Research Site

George Town, Pulau Pinang, Malaysia

Site Status

Research Site

Kota Kinabalu, Sabah, Malaysia

Site Status

Research Site

Asajaya, Sarawak, Malaysia

Site Status

Research Site

Banting, Selangor, Malaysia

Site Status

Research Site

Rawang, Selangor, Malaysia

Site Status

Research Site

Bandar Permaisuri, Terengganu, Malaysia

Site Status

Research Site

Kuala Terengganu, Terengganu, Malaysia

Site Status

Countries

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Malaysia

References

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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.

Reference Type DERIVED
PMID: 32723990 (View on PubMed)

Related Links

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http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=14738&filename=ASCOPE_Synopsis_CTT.pdf

CSR Synopsis

Other Identifiers

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D2287R00120

Identifier Type: -

Identifier Source: org_study_id