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Trial record 43 of 183 for:    Foradil Combi OR symbicort OR (Budesonide AND formeterol)

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

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ClinicalTrials.gov Identifier: NCT00576316
Recruitment Status : Completed
First Posted : December 19, 2007
Results First Posted : December 29, 2009
Last Update Posted : December 16, 2010
Sponsor:
Information provided by:
AstraZeneca

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Asthma
Intervention Drug: Symbicort Turbuhaler 160/4.5
Enrollment 201
Recruitment Details 201 patients were recruited from 10 government hospital based outpatient clinics from Dec 2007 until May 2008
Pre-assignment Details  
Arm/Group Title Symbicort 160/4.5 Turbuhaler
Hide Arm/Group Description Treatment with Symbicort 160/4.5 Turbuhaler 1 or 2 inhalations twice daily and when required as reliever
Period Title: Overall Study
Started 201 [1]
Completed 181 [2]
Not Completed 20
Reason Not Completed
Adverse Event             9
Withdrawal by Subject             2
Protocol Violation             9
[1]
Number of patients recruited
[2]
Number of patients who completed study
Arm/Group Title Symbicort 160/4.5 Turbuhaler
Hide Arm/Group Description Treatment with Symbicort 160/4.5 Turbuhaler 1 or 2 inhalations twice daily and when required as reliever
Overall Number of Baseline Participants 201
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Mean Age Number Analyzed 201 participants
46.73  (12.31)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 201 participants
Female
155
  77.1%
Male
46
  22.9%
1.Primary Outcome
Title 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
Hide Description Difference/change in SATQ score between baseline and mean of 3 months and 6 months after SMART treatment as analysed by paired t-test. SATQ is a patient reported questionnaire which consists of 26 questions and scored to a scale of 1-7, the higher score indicating a greater level of satisfaction
Time Frame 6 months after each patient was initially treated with Symbicort SMART
Hide Outcome Measure Data
Hide Analysis Population Description
201 participants were recruited but statistical analysis was completed for 195 participants
Arm/Group Title Symbicort 160/4.5 Turbuhaler
Hide Arm/Group Description:
Treatment with Symbicort 160/4.5 Turbuhaler 1 or 2 inhalations twice daily and when required as reliever
Overall Number of Participants Analyzed 195
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
0.37  (0.73)
2.Secondary Outcome
Title 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
Hide Description Difference/change in ACQ-5 scores between baseline and mean of 3 months and 6 months after SMART treatment. ACQ-5 is a 5 question patient reported outcome measuring level of asthma control during the past 7 days and it is scored on scale of 0-6. 0 indicates no symptoms and 6 represents severe symptoms
Time Frame 6 months after each patient was initially treated with Symbicort SMART
Hide Outcome Measure Data
Hide Analysis Population Description
201 participants were recruited but statistical analysis was completed for 195 participants
Arm/Group Title Symbicort 160/4.5 Turbuhaler
Hide Arm/Group Description:
Treatment with Symbicort 160/4.5 Turbuhaler 1 or 2 inhalations twice daily and when required as reliever
Overall Number of Participants Analyzed 195
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.97  (1.22)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Symbicort 160/4.5 Turbuhaler
Hide Arm/Group Description Treatment with Symbicort 160/4.5 Turbuhaler 1 or 2 inhalations twice daily and when required as reliever
All-Cause Mortality
Symbicort 160/4.5 Turbuhaler
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Symbicort 160/4.5 Turbuhaler
Affected / at Risk (%)
Total   17 
Cardiac disorders   
Congestive Cardiac Failure  1  1/195 (0.51%) 
Ear and labyrinth disorders   
Vestibular Neuronitis  1  1/195 (0.51%) 
General disorders   
Secretion And Pyrexia  1  3/195 (1.54%) 
Infections and infestations   
Upper Respiratory Tract Infection  1  5/195 (2.56%) 
Respiratory, thoracic and mediastinal disorders   
Asthma  1  15/195 (7.69%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Symbicort 160/4.5 Turbuhaler
Affected / at Risk (%)
Total   70 
General disorders   
General discomfort  1  11/195 (5.64%) 
Respiratory, thoracic and mediastinal disorders   
Upper respiratory tract infection  1  26/195 (13.33%) 
Productive Cough  1  33/195 (16.92%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
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.
Results Point of Contact
Name/Title: Gerard Lynch
Organization: AstraZeneca
ClinicalTrials.gov Identifier: NCT00576316     History of Changes
Other Study ID Numbers: D5890L00027
First Submitted: December 17, 2007
First Posted: December 19, 2007
Results First Submitted: November 19, 2009
Results First Posted: December 29, 2009
Last Update Posted: December 16, 2010