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Assessment of Asthma Control Level in Malaysia (ASCORE)

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ClinicalTrials.gov Identifier: NCT03295331
Recruitment Status : Completed
First Posted : September 27, 2017
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date August 29, 2017
First Posted Date September 27, 2017
Last Update Posted Date May 11, 2018
Actual Study Start Date January 3, 2017
Actual Primary Completion Date April 5, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 21, 2017)
Level of GINA-defined asthma control [ Time Frame: up to 8 months ]
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 21, 2017)
  • Types of medication prescribed for asthma control [ Time Frame: up to 8 months ]
    Pharmacological management used for asthma control
  • Asthma control level [ Time Frame: up to 8 months ]
    Asthma control level measured by Asthma Control Test (ACT) score
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Assessment of Asthma Control Level in Malaysia
Official Title A Non-Interventional Retrospective Study To Assess The Level Of Asthma Control Among Adults at 2 Tertiary Care Centres In Malaysia
Brief 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
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
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Tertiary Care Centre ( patients seen at outpatient physicians )
Condition Asthma Control Level
Intervention Not Provided
Study Groups/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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 21, 2017)
398
Original Actual Enrollment Same as current
Actual Study Completion Date April 5, 2017
Actual Primary Completion Date April 5, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

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:

  • Clinical features suggesting emphysema or chronic bronchitis
  • Other de-compensated organ failures
Sex/Gender
Sexes Eligible for Study: Female
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Malaysia
Removed Location Countries  
 
Administrative Information
NCT Number NCT03295331
Other Study ID Numbers D2287R00116
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: N/A, Non interventional Study , observational study. No patient involved
Responsible Party AstraZeneca
Study Sponsor AstraZeneca
Collaborators Not Provided
Investigators Not Provided
PRS Account AstraZeneca
Verification Date May 2018