A Comparison of Symbicort® Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma (PASSION)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00628758
First received: January 10, 2008
Last updated: July 6, 2012
Last verified: July 2012
Results First Received: September 18, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: Symbicort TBH - Turbuhaler
Drug: beta-II-agonist, inhale steroid

  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
FSI: LSI: LSO: Center type: Research and Training Host, Chest Medicine and Internal Medicine 23 Clinics. Number of enrolled subjects: 432, randomized: 430, completed patients: 344 ( Arm A:165, Arm B 179)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Symbicort Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need)
Conventional BP Conventional Best Practice for Treatment of asthma

Participant Flow:   Overall Study
    Symbicort     Conventional BP  
STARTED     209     221  
COMPLETED     165     179  
NOT COMPLETED     44     42  
Adverse Event                 2                 3  
Withdrawal by Subject                 6                 3  
Death                 1                 0  
Protocol Violation                 5                 1  
Lost to Follow-up                 25                 31  
Pregnancy                 2                 2  
Investigator Moved                 3                 0  
Treatment Failure                 0                 2  



  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.
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Reporting Groups
  Description
Symbicort Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need)
Conventional BP Conventional Best Practice for Treatment of asthma
Total Total of all reporting groups

Baseline Measures
    Symbicort     Conventional BP     Total  
Number of Participants  
[units: participants]
  209     221     430  
Age  
[units: years]
Mean ± Standard Deviation
  44.28  ± 12.09     45.17  ± 12.71     44.7  ± 12.4  
Gender  
[units: Participants]
     
Female     157     179     336  
Male     52     42     94  



  Outcome Measures
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1.  Primary:   Time to First Severe Asthma Exacerbation   [ Time Frame: 26 weeks ]

2.  Secondary:   Number of Severe Asthma Exacerbations   [ Time Frame: 26 weeks ]

3.  Secondary:   Change in Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) Score   [ Time Frame: Baseline and 26 weeks ]

4.  Secondary:   Mean Use of As-needed Medication Per Day During Treatment Period   [ Time Frame: Daily recording during the treatment period of 26 weeks ]


  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
phone: +44 1509 645895
e-mail: aztrial_results_posting@astrazeneca.com


No publications provided


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00628758     History of Changes
Other Study ID Numbers: D5890L00016
Study First Received: January 10, 2008
Results First Received: September 18, 2009
Last Updated: July 6, 2012
Health Authority: Turkey: Ministry of Health