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NCT Number: NCT03804632

Assessment of Asthma Control Level in Primary Care Setting in Malaysia

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Port Dickson, Negeri Sembilan, Malaysia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Level of GINA-defined asthma control

    Time frame: up to 8 months

    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.

Secondary outcomes

  1. Types of medication prescribed for asthma control

    Time frame: up to 8 months

    Pharmacological management used for asthma control

  2. Asthma control level

    Time frame: up to 8 months

    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.

  3. Adherence level in patients with inhalers

    Time frame: up to 8 months

    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)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: ASCOPE

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 15, 2019
Registry last updated
May 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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