Symbicort Maintenance and Reliever Therapy - Experience in Real Life Setting in Malaysia (SMARTER)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00576316
First received: December 17, 2007
Last updated: November 30, 2010
Last verified: November 2010
Results First Received: November 19, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Asthma
Intervention: Drug: Symbicort Turbuhaler 160/4.5

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
201 patients were recruited from 10 government hospital based outpatient clinics from Dec 2007 until May 2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Symbicort 160/4.5 Turbuhaler Treatment with Symbicort 160/4.5 Turbuhaler 1 or 2 inhalations twice daily and when required as reliever

Participant Flow:   Overall Study
    Symbicort 160/4.5 Turbuhaler  
STARTED     201 [1]
COMPLETED     181 [2]
NOT COMPLETED     20  
Adverse Event                 9  
Withdrawal by Subject                 2  
Protocol Violation                 9  
[1] Number of patients recruited
[2] Number of patients who completed study



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Symbicort 160/4.5 Turbuhaler Treatment with Symbicort 160/4.5 Turbuhaler 1 or 2 inhalations twice daily and when required as reliever

Baseline Measures
    Symbicort 160/4.5 Turbuhaler  
Number of Participants  
[units: participants]
  201  
Age  
[units: years]
Mean ± Standard Deviation
 
Mean Age     46.73  ± 12.31  
Gender  
[units: Participants]
 
Female     155  
Male     46  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Satisfaction With Asthma Treatment Questionnaire (SATQ) Scores From Baseline to the Mean of 3 Months and 6 Months After Patient Was Initially Treated With SMART   [ Time Frame: 6 months after each patient was initially treated with Symbicort SMART ]

2.  Secondary:   Changes in Asthma Control Questionnaire (ACQ-5) Score From Baseline to the Mean of 3 Months and 6 Months After Patient Was Initially Treated With SMART   [ Time Frame: 6 months after each patient was initially treated with Symbicort SMART ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com


No publications provided


ClinicalTrials.gov Identifier: NCT00576316     History of Changes
Other Study ID Numbers: D5890L00027
Study First Received: December 17, 2007
Results First Received: November 19, 2009
Last Updated: November 30, 2010
Health Authority: Malaysia: Ministry of Health