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CompletedNCT03295331ASCOREUpdated May 11, 2018

Assessment of Asthma Control Level in Malaysia

An observational study in Asthma Control Level, sponsored by AstraZeneca. Completed at 2 sites in Malaysia. Open to female participants. Per ClinicalTrials.gov, last updated 2018-05-11.

Sponsored by AstraZeneca · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
398
Sex
Female
01

Study summary

A Non-Interventional Retrospective Study To Assess The Level Of Asthma Control Among Adults at 2 Tertiary Care Centres In Malaysia; Institute Of Respiratory Medicine (IPR) And Hospital Serdang. 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

Read the 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 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

02

Conditions studied

  • Asthma Control Level

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03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Tertiary Care Centre ( patients seen at outpatient physicians )

Inclusion criteria

  • All patients with GINA-defined clinical diagnosis of Asthma seen at respiratory clinic from January to August 2016.
  • Be at least 18 years of age

Exclusion criteria

Exclusion Criteria:

  • Clinical features suggesting emphysema or chronic bronchitis
  • Other de-compensated organ failures
04

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
398 participants (actual)
Patient registry
No

Groups and cohorts

  • GINA-defined clinical diagnosis of Asthma

    All patients with GINA-defined clinical diagnosis of Asthma seen at respiratory clinic from January to August 2016 with age 18 and above

05

What researchers measure

Primary outcomes

  1. Level of GINA-defined asthma control

    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

    Time frame: up to 8 months

Secondary outcomes

  1. Types of medication prescribed for asthma control

    Pharmacological management used for asthma control

    Time frame: up to 8 months

  2. Asthma control level

    Asthma control level measured by Asthma Control Test (ACT) score

    Time frame: up to 8 months

06

Study locations

2 sites
  • Hospital Serdang
    Kajang, Selangor, Malaysia
  • Institut Perubatan Respiratori
    Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia
07

References and documents

Related links

Individual participant data

Plan to share: No — N/A, Non interventional Study , observational study. No patient involved

08

Registry details

Key details

Study ID
NCT03295331
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Sep 27, 2017
Start date
Jan 3, 2017
Primary completion
Apr 5, 2017
Completion
Apr 5, 2017
Last update
May 11, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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