Symbicort Single Inhaler Therapy vs Conventional Best Practice for the Treatment of Persistent Asthma in Adults

This study has been terminated.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00385593
First received: October 6, 2006
Last updated: November 30, 2010
Last verified: November 2010
Results First Received: October 14, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Asthma, Bronchial
Interventions: Drug: Symbicort (budesonide/formoterol) Turbuhaler
Drug: Conventional treatment

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
654

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
SMART Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
Conv. Best Practice Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator’s clinical judgement.

Participant Flow:   Overall Study
    SMART     Conv. Best Practice  
STARTED     328     326  
COMPLETED     270     289  
NOT COMPLETED     58     37  
Adverse Event                 3                 2  
Withdrawal by Subject                 17                 7  
Lost to Follow-up                 12                 8  
Protocol Violation                 7                 4  
Several reasons                 17                 15  
Incorrect inclusion                 2                 0  
Incorrect randomization                 0                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

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
SMART Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
Conv. Best Practice Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator’s clinical judgement.
Total Total of all reporting groups

Baseline Measures
    SMART     Conv. Best Practice     Total  
Number of Participants  
[units: participants]
  328     326     654  
Age  
[units: Years]
Mean ± Standard Deviation
  43.7  ± 16.4     44.3  ± 16.5     44.0  ± 16.5  
Gender  
[units: Participants]
     
Female     218     202     420  
Male     110     124     234  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Time to First Severe Asthma Exacerbation   [ Time Frame: Baseline up to 6 months ]

2.  Secondary:   Total Number of Severe Exacerbations   [ Time Frame: Baseline up to 6 months ]

3.  Secondary:   Mean Use of as Needed Medication   [ Time Frame: Baseline up to 6 months ]

4.  Secondary:   Use of Inhaled Steroids   [ Time Frame: Baseline up to 6 months ]

5.  Secondary:   Change in the Asthma Control Questionnaire(ACQ) Score   [ Time Frame: Daily 14 days prior to each of visit 2-4 ]

6.  Secondary:   Peak Expiratory Flow (PEF)   [ Time Frame: 6 months (end of the study) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
The study was prematurely stopped, because it was not possible to recruit the sample size required in the period of time established.


  More Information
  Hide More Information

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


ClinicalTrials.gov Identifier: NCT00385593     History of Changes
Other Study ID Numbers: D5890L00010, 2005-005974-64, SPAIN
Study First Received: October 6, 2006
Results First Received: October 14, 2009
Last Updated: November 30, 2010
Health Authority: Spain: Spanish Agency of Medicines