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
Results First Received: February 21, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: Symbicort Turbuhaler
Drug: Terbutaline Turbuhaler

  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
The first participant entered the study on 16 February 2009, and the last participant completed the study on 23 February 2011. A total of 3209 participants were enrolled at 148 centres in 13 countries in Asia, America and Europe, and 2091 participants who fulfilled the randomisation criteria were randomised.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study started with an enrolment visit, Visit 1, 1-7 days prior to Visit 2 (run-in). At Visit 2 patients had to have a reversibility of ≥12% relative to baseline and their pre-bronchodilatory Forced expiratory volume in one second (FEV1) had to be ≥50% of the predicted normal value.

Reporting Groups
  Description
Symbicort SMART Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
Symbicort+Terbutaline As Needed Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed

Participant Flow:   Overall Study
    Symbicort SMART     Symbicort+Terbutaline As Needed  
STARTED     1049     1042  
COMPLETED     956     932  
NOT COMPLETED     93     110  
Adverse Event                 8                 12  
Lost to Follow-up                 31                 26  
Withdrawal by Subject                 28                 34  
Incorrect Enrolment                 3                 3  
Study-Specific Discontinuation Criteria                 6                 13  
Safety Reasons                 2                 1  
Not Specified                 8                 14  
Severe Non-Compliance to Protocol                 7                 7  



  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 SMART Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
Symbicort+Terbutaline As Needed Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
Total Total of all reporting groups

Baseline Measures
    Symbicort SMART     Symbicort+Terbutaline As Needed     Total  
Number of Participants  
[units: participants]
  1049     1042     2091  
Age  
[units: years]
Mean ( Full Range )
  45.7  
  ( 16 to 84 )  
  45.6  
  ( 16 to 85 )  
  45.7  
  ( 16 to 85 )  
Gender  
[units: Participants]
     
Female     722     692     1414  
Male     327     350     677  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Percentage of Participants Who Had Experienced Asthma Exacerbation(s) at the End of the Study   [ Time Frame: week 52 ]

2.  Secondary:   Number of Asthma Exacerbations   [ Time Frame: up to 52 weeks ]

3.  Secondary:   Morning Peak Expiratory Flow (PEF)   [ Time Frame: 52-week treatment period ]

4.  Secondary:   Evening PEF   [ Time Frame: 2-week run-in period (14 - 18 days before randomization - week 0) and a 52-week treatment period ]

5.  Secondary:   Forced Expiratory Volume in One Second (FEV1)   [ Time Frame: 4, 12, 24, 36 and 52 weeks after randomization ]

6.  Secondary:   Use of As-needed Medication   [ Time Frame: 52-week treatment period ]

7.  Secondary:   Asthma Symptom Score   [ Time Frame: 52-week treatment period ]

8.  Secondary:   Nights With Awakening(s) Due to Asthma Symptoms   [ Time Frame: 52-week treatment period ]

9.  Secondary:   The Percentage of Participants Who Had Experienced First Mild Asthma Exacerbations   [ Time Frame: up to 52 weeks ]

10.  Secondary:   Symptom-free Days (no Symptoms and no Awakenings)   [ Time Frame: 52-week treatment period ]

11.  Secondary:   Percentage of As-needed-free Days   [ Time Frame: 52-week treatment period ]

12.  Secondary:   Percentage of Asthma-control Days (no Asthma Symptoms, no Awakenings, and no As-needed Use)   [ Time Frame: 52-week treatment period ]

13.  Secondary:   Asthma Control Questionnaire (ACQ)   [ Time Frame: 4, 12, 24, 36 and 52 weeks after randomization ]


  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


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


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00839800     History of Changes
Other Study ID Numbers: D589LC00001
Study First Received: February 4, 2009
Results First Received: February 21, 2012
Last Updated: November 26, 2012
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: National Health Surveillance Agency
China: Ministry of Health
China: Food and Drug Administration
Costa Rica: CEC-UCIMED
Hungary: National Institute of Pharmacy
India: Drugs Controller General of India
Japan: Ministry of Health, Labor and Welfare
Malaysia: Ministry of Health
Philippines: Bureau of Food and Drugs
Russia: Ministry of Health of the Russian Federation
South Korea: Korea Food and Drug Administration (KFDA)
Thailand: Ethical Committee