Study to Investigate the Efficacy of Symbicort® SMART. (SAKURA)
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|ClinicalTrials.gov Identifier: NCT00839800|
Recruitment Status : Completed
First Posted : February 10, 2009
Results First Posted : November 30, 2012
Last Update Posted : November 30, 2012
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: Symbicort Turbuhaler Drug: Terbutaline Turbuhaler||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2091 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Comparison of Symbicort® SMART (160/4.5μg) and Symbicort® Turbuhaler 160/4.5 μg, Plus Terbutaline Turbuhaler 0.4 mg as Needed, for Treatment of Asthma - a 12-month, Randomized, Double-blind, Parallel Group, Active-controlled, Multinational Phase III Study in Asthmatic Patients From 16 Years|
|Study Start Date :||February 2009|
|Primary Completion Date :||February 2011|
|Study Completion Date :||February 2011|
Symbicort Turbuhaler 160/4.5 µg one inhalation bid (twice daily) + Symbicort Turbuhaler 160/4.5 µg as needed
Drug: Symbicort Turbuhaler
Active Comparator: 2
Symbicort Turbuhaler 160/4.5 µg one inhalation bid (twice daily) + terbutaline Turbuhaler 0.4 mg as needed
Drug: Symbicort Turbuhaler
160/4.5 µgDrug: Terbutaline Turbuhaler
- The Percentage of Participants Who Had Experienced Asthma Exacerbation(s) at the End of the Study [ Time Frame: week 52 ]Asthma exacerbation was defined as deterioration in asthma leading to oral glucocorticosteroid [GCS] treatment, hospitalization, or emergency room [ER] treatment.
- Number of Asthma Exacerbations [ Time Frame: up to 52 weeks ]Asthma exacerbation was defined as deterioration in asthma leading to oral GCS treatment, hospitalization, or ER treatment. Number of asthma exacerbations during 52 weeks treatment was presented here.
- Morning Peak Expiratory Flow (PEF) [ Time Frame: 52-week treatment period ]The mean value from a 52-week treatment period.
- Evening PEF [ Time Frame: 2-week run-in period (14 - 18 days before randomization - week 0) and a 52-week treatment period ]The mean value from a 52-week treatment period.
- Forced Expiratory Volume in One Second (FEV1) [ Time Frame: 4, 12, 24, 36 and 52 weeks after randomization ]The mean value for Weeks 4, 12, 24, 36 and 52 was analysed.
- Use of As-needed Medication [ Time Frame: 52-week treatment period ]The mean value of total daily number of inhalations from the treatment period for use of as-needed medication (daytime, night-time).
- Asthma Symptom Score [ Time Frame: 52-week treatment period ]The mean value from the treatment period for Total Asthma Symptom Score (total score: 0 is best - no asthma symptoms; 6 is worst).
- Nights With Awakening(s) Due to Asthma Symptoms [ Time Frame: 52-week treatment period ]The mean value from the treatment period was presented here.
- The Percentage of Participants Who Had Experienced First Mild Asthma Exacerbations [ Time Frame: up to 52 weeks ]Mild asthma exacerbation was defined as morning PEF ≥20% below baseline, daily as-needed medication use ≥2 inhalations above baseline, or a night with awakening due to asthma symptoms. The percentage of participants who had experienced mild asthma exacerbation(s) at the end of the study was presented here.
- Symptom-free Days (no Symptoms and no Awakenings) [ Time Frame: 52-week treatment period ]A symptom-free day was defined as a day without daytime or night-time symptoms and without night-time awakenings due to asthma symptoms. The mean value was presented here.
- Percentage of As-needed-free Days [ Time Frame: 52-week treatment period ]An as-needed-free day is defined as a night and day with no use of as-needed medication. The mean value from the treatment period was presented here.
- Percentage of Asthma-control Days (no Asthma Symptoms, no Awakenings, and no As-needed Use) [ Time Frame: 52-week treatment period ]An asthma-control day was defined as a a night and day with no asthma symptoms, no awakenings due to asthma symptoms, and no as-needed medication use. The mean value from the treatment period was presented here.
- Asthma Control Questionnaire (ACQ) [ Time Frame: 4, 12, 24, 36 and 52 weeks after randomization ]The ACQ developed by Juniper and colleagues (Juniper et al 1999) was used without the FEV1 and Beta 2-agonist questions. The Asthma Control Questionnaire has 5 questions that are assessed on a 7-point scale from 0 to 6 where 0 represents good control and 6 represents poor control. The overall score is the mean of the five responses. At least 4 out of the 5 questions must have been answered to provide a value. The mean of the overall score for Weeks 4 to 52 was presented here.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00839800
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|Study Director:||Tomas Andersson, MD||AstraZeneca R&D Lund|
|Principal Investigator:||Tito Atienza, M.D.||Mary Mediatrix Medical Center, Lipa City, Philippines|