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Study to Investigate the Safety and Efficacy of High Dose of Symbicort® SMART in Japanese Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00837967
First received: February 5, 2009
Last updated: August 27, 2012
Last verified: August 2012
Results First Received: July 5, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Crossover 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
Patients recruited from 2 hospitals in Japan between January 2009 and July 2009. 28 patients enrolled; 25 patients randomized, 3 patients were not randomized (1 due to incorrect enrollment and 2 due to adverse event)     

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Symbicort First, Then Terbutaline Symbicort Turbuhaler 160/4.5μg for 3 days First , then Terbutaline Turbuhaler 0.4 mg for 3 days
Terbutaline First, Then Symbicort Terbutaline Turbuhaler 0.4 mg for 3 days First, then Symbicort Turbuhaler 160/4.5μg for 3 days,

Participant Flow for 3 periods

Period 1:   First Intervention
    Symbicort First, Then Terbutaline     Terbutaline First, Then Symbicort  
STARTED     13     12  
COMPLETED     13     12  
NOT COMPLETED     0     0  

Period 2:   Washout Period of 7 - 14 Days
    Symbicort First, Then Terbutaline     Terbutaline First, Then Symbicort  
STARTED     13     12  
COMPLETED     11     12  
NOT COMPLETED     2     0  
Adverse Event                 2                 0  

Period 3:   Second Intervention
    Symbicort First, Then Terbutaline     Terbutaline First, Then Symbicort  
STARTED     11     12  
COMPLETED     11     12  
NOT COMPLETED     0     0  



  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
All Study Participants No text entered.

Baseline Measures
    All Study Participants  
Number of Participants  
[units: participants]
  25  
Age  
[units: years]
Mean ± Standard Deviation
  44.3  ± 14.8  
Gender  
[units: Participants]
 
Female     15  
Male     10  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Adverse Events   [ Time Frame: 3 days ]

2.  Primary:   Serum Potassium - Average Concentration From Trapezoidal Area Under the Curve (AUC)   [ Time Frame: up to 740 min after start dosing for each treatment day ]

3.  Primary:   Blood Glucose - Average Concentration From Trapezoidal Area Under the Curve (AUC)   [ Time Frame: up to 140 min after start dosing for each treatment day ]

4.  Primary:   Electrocardiogram (ECG)- Average Trapezoidal Area Under the Curve (AUC)   [ Time Frame: up to 740 min after start dosing for each treatment day ]

5.  Primary:   Vital Sign (Blood Pressure)- Average Trapezoidal Area Under the Curve (AUC)   [ Time Frame: up to 740 min after start dosing for each treatment day ]

6.  Primary:   Vital Sign (Pulse Rate)- Average Trapezoidal Area Under the Curve (AUC)   [ Time Frame: up to 740 min after start dosing for each treatment day ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
e-mail: aztrial_results_posting@astrazeneca.com


No publications provided by AstraZeneca

Publications automatically indexed to this study:

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00837967     History of Changes
Other Study ID Numbers: D589LC00003
Study First Received: February 5, 2009
Results First Received: July 5, 2010
Last Updated: August 27, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare