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Assessment of Asthma Control Level in Malaysia (ASCORE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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

Condition or disease
Asthma Control Level

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

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Study Type : Observational
Actual Enrollment : 398 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: A Non-Interventional Retrospective Study To Assess The Level Of Asthma Control Among Adults at 2 Tertiary Care Centres In Malaysia
Actual Study Start Date : January 3, 2017
Actual Primary Completion Date : April 5, 2017
Actual Study Completion Date : April 5, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Group/Cohort
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  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 level measured by Asthma Control Test (ACT) score



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Tertiary Care Centre ( patients seen at outpatient physicians )
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03295331


Locations
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Malaysia
Hospital Serdang
Kajang, Selangor, Malaysia
Institut Perubatan Respiratori
Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia
Sponsors and Collaborators
AstraZeneca
Additional Information:
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03295331    
Other Study ID Numbers: D2287R00116
First Posted: September 27, 2017    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: N/A, Non interventional Study , observational study. No patient involved

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases