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Study to Investigate the Efficacy of Symbicort® SMART. (SAKURA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00839800
First received: February 4, 2009
Last updated: November 26, 2012
Last verified: November 2012
History of Changes

February 4, 2009
November 26, 2012
February 2009
February 2011   (final data collection date for primary outcome measure)
The Percentage of Participants Who Had Experienced Asthma Exacerbation(s) at the End of the Study [ Time Frame: week 52 ] [ Designated as safety issue: No ]
Asthma exacerbation was defined as deterioration in asthma leading to oral glucocorticosteroid [GCS] treatment, hospitalization, or emergency room [ER] treatment.
Asthma exacerbations [ Time Frame: daily ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00839800 on ClinicalTrials.gov Archive Site
  • Number of Asthma Exacerbations [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The mean value for Weeks 4, 12, 24, 36 and 52 was analysed.
  • Use of As-needed Medication [ Time Frame: 52-week treatment period ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
  • Number of asthma exacerbations [ Time Frame: End of study period ] [ Designated as safety issue: No ]
  • Lung function [ Time Frame: daily ] [ Designated as safety issue: No ]
  • Asthma control [ Time Frame: daily ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study to Investigate the Efficacy of Symbicort® SMART.
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

The primary objective of this study is to compare the efficacy of Symbicort SMART (Symbicort Turbuhaler 160/4.5μg, one inhalation twice daily plus as needed) with Symbicort Turbuhaler 160/4.5μg, one inhalation twice daily plus terbutaline Turbuhaler 0.4 mg as needed, as asthma therapy
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Asthma
  • Drug: Symbicort Turbuhaler
    160/4.5 µg
  • Drug: Terbutaline Turbuhaler
    0.4 mg
  • Experimental: 1
    Symbicort Turbuhaler 160/4.5 µg one inhalation bid (twice daily) + Symbicort Turbuhaler 160/4.5 µg as needed
    Intervention: Drug: Symbicort Turbuhaler
  • Active Comparator: 2
    Symbicort Turbuhaler 160/4.5 µg one inhalation bid (twice daily) + terbutaline Turbuhaler 0.4 mg as needed
    Interventions:
    • Drug: Symbicort Turbuhaler
    • Drug: Terbutaline Turbuhaler
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2091
February 2011
February 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of asthma according to the Global Initiative for Asthma guidelines (GINA) 2007 with a documented history of at least 6 months duration.
  • Reversible airway obstruction, defined as an increase in FEV1 ≥12% relative to baseline for all patients 15-30 minutes after inhalation of in total 2 x 0.4 mg terbutaline Turbuhaler
  • Prescribed use of inhaled glucocorticoid steroid (GCS) (any brand) for at least 12 weeks.

Exclusion Criteria:

  • Respiratory infection affecting the asthma, as judged by the investigator, within 4 weeks.
  • Intake of oral, rectal or parenteral GCS within 4 weeks and/or depot parenteral GCS within 12 weeks.
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Brazil,   China,   Costa Rica,   Hungary,   India,   Japan,   Korea, Republic of,   Malaysia,   Peru,   Philippines,   Thailand
 
NCT00839800
D589LC00001
No
AstraZeneca
AstraZeneca
Not Provided
Study Director: Tomas Andersson, MD AstraZeneca R&D Lund
Principal Investigator: Tito Atienza, M.D. Mary Mediatrix Medical Center, Lipa City, Philippines
AstraZeneca
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP