Clinical trial NCT03804632: Assessment of Asthma Control Level in Primary Care Setting in Malaysia
Official title: A Prospective Observational Multi Center Study to Assess the Level of Asthma Control at Government Health Clinics (Klinik Kesihatan) in Malaysia.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma Control Level
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2019-01-15
Enrollment: 1011
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients seen and treated by health care providers at government health clinics.

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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Level of GINA-defined asthma control
timeFrame: up to 8 months
Secondary outcomes:
measure: Types of medication prescribed for asthma control
timeFrame: up to 8 months
measure: Asthma control level
timeFrame: up to 8 months
measure: Adherence level in patients with inhalers
timeFrame: up to 8 months
Other outcomes:
Locations:
city: Port Dickson
country: Malaysia
facility: Research Site
state: Negeri Sembilan
city: Seremban
country: Malaysia
facility: Research Site
state: Negeri Sembilan
city: George Town
country: Malaysia
facility: Research Site
state: Penang
city: Pantai Remis
country: Malaysia
facility: Research Site
state: Perak
city: Kota Kinabalu
country: Malaysia
facility: Research Site
state: Sabah
city: Asajaya
country: Malaysia
facility: Research Site
state: Sarawak
city: Banting
country: Malaysia
facility: Research Site
state: Selangor
city: Rawang
country: Malaysia
facility: Research Site
state: Selangor
city: Bandar Permaisuri
country: Malaysia
facility: Research Site
state: Terengganu
city: Kuala Terengganu
country: Malaysia
facility: Research Site
state: Terengganu
Study officials:
References:
citation: 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.