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Comparison of Asthma-related Outcomes and Costs in Pediatric Subjects That Received Fluticasone Propionate, Budesonide or Montelukast in a Large Managed Care Population

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01328964
First received: March 4, 2010
Last updated: September 8, 2011
Last verified: August 2011
History of Changes
Results First Received: April 8, 2011  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Retrospective
Condition: Asthma
Interventions: Drug: Fluticasone propionate
Drug: Budesonide
Drug: Montelukast

  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
This was a retrospective observational study utilizing a large managed care database with linked pharmacy and medical claims. The dose of each inhaled corticosteroid was not known in the database.

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
Fluticasone Propionate Pediatric participants aged 4-11 years that received fluticasone propionate 44 micrograms (FP44) for the treatment of asthma
Budesonide Pediatric participants aged 4-11 years that received budesonide for the treatment of asthma
Montelukast Pediatric participants aged 4-11 years that received montelukast for the treatment of asthma

Participant Flow:   Overall Study
    Fluticasone Propionate     Budesonide     Montelukast  
STARTED     2212     3270     4424  
COMPLETED     2212     3270     4424  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Fluticasone Propionate Pediatric participants aged 4-11 years that received fluticasone propionate 44 micrograms (FP44) for the treatment of asthma
Budesonide Pediatric participants aged 4-11 years that received budesonide for the treatment of asthma
Montelukast Pediatric participants aged 4-11 years that received montelukast for the treatment of asthma
Total Total of all reporting groups

Baseline Measures
    Fluticasone Propionate     Budesonide     Montelukast     Total  
Number of Participants  
[units: participants]
 		  2212     3270     4424     9906  
Age  
[units: Years]
Mean ± Standard Deviation 		  7.18  ± 2.20     7.30  ± 2.27     7.21  ± 2.23     7.23  ± 2.23  
Gender  
[units: Participants]
 		       
Female     897     1267     1797     3961  
Male     1315     2003     2627     5945  



  Outcome Measures
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1.  Primary:   Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years   [ Time Frame: January 1, 2000 to June 30, 2008 ]
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2.  Secondary:   Mean Monthly Asthma-related Costs (Pharmacy and Medical) During the Post-index Period   [ Time Frame: 12 months prior to January 1, 2000 to June 30, 2008 ]
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3.  Secondary:   Number of Asthma-related Hospitalizations, Asthma-related Emergency Department (ED) Visits, and Combined Hospitalizations/ED Visits Represented Per 100 Person Years   [ Time Frame: 12 months prior to January 1, 2000 to June 30, 2008 ]
  Show Outcome Measure 3

4.  Secondary:   Mean Monthly Asthma-related Costs (Pharmacy and Medical) During the Post-index Period   [ Time Frame: 12 months prior to January 1, 2000 to June 30, 2008 ]
  Show Outcome Measure 4


  Serious Adverse Events
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  Other Adverse Events
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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 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: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided


Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01328964     History of Changes
Other Study ID Numbers: 112608
Study First Received: March 4, 2010
Results First Received: April 8, 2011
Last Updated: September 8, 2011
Health Authority: United States: No Health Authority