Study to Investigate the Efficacy of Symbicort SMART (SAKURA)


Tracking Information

Start Date  ICMJEFebruary 2009
Primary Completion Date 
Current Primary Outcome Measures  ICMJE 
 (submitted: February 9, 2009)		Asthma exacerbations [ Time Frame: daily ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00839800 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: February 9, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEStudy to Investigate the Efficacy of Symbicort SMART.
Official Title  ICMJEA 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
Brief Summary

The primary objective of this study is to compare the efficacy of Symbicort SMART (Symbicort Turbuhaler 160/4.5μg, one inhalation bid plus as needed) with Symbicort Turbuhaler 160/4.5μg, one inhalation bid plus terbutaline Turbuhaler 0.4 mg as needed, as asthma therapy

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Condition  ICMJEAsthma
Intervention  ICMJE
  • Drug: Symbicort Turbuhaler
    160/4.5 µg
  • Drug: Terbutaline Turbuhaler
    0.4 mg
Study Arms / Comparison Groups
  • 1: Experimental
    Symbicort Turbuhaler 160/4.5 µg one inhalation bid + Symbicort Turbuhaler 160/4.5 µg as needed
    Intervention: Drug: Symbicort Turbuhaler
  • 2: Active Comparator
    Symbicort Turbuhaler 160/4.5 µg one inhalation bid + terbutaline Turbuhaler 0.4 mg as needed
    Interventions:
    • Drug: Symbicort Turbuhaler
    • Drug: Terbutaline Turbuhaler

Recruitment Information

Estimated Enrollment  ICMJE1800
Estimated Completion DateFebruary 2011
Primary Completion Date 
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of asthma according to 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 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.
GenderBoth
Ages16 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: AstraZeneca Clinical Study Information800-236-9933information.center@astrazeneca.com
Location Countries  ICMJEArgentina,   Brazil,   China,   Costa Rica,   Hungary,   India,   Japan,   Korea, Republic of,   Malaysia,   Peru,   Philippines,   Russian Federation,   Thailand

Administrative Information

NCT ID  ICMJENCT00839800
Responsible PartyTomas Andersson, MD, Medical Science Director Symbicort, AstraZeneca
Study ID Numbers  ICMJED589LC00001
Study Sponsor  ICMJEAstraZeneca
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Tomas Andersson, MDAstraZeneca R&D Lund
Principal Investigator:Tito Atienza, M.D.Mary Mediatrix Medical Center, Lipa City, Philippines
Information Provided ByAstraZeneca