Chronic Obstructive Pulmonary Disease (COPD)-Related Outcomes and Costs for Patients on Combination Fluticasone Propionate-Salmeterol Xinafoate 250/50mcg Versus Anticholinergics in a COPD-Comorbid Depression/Anxiety Population

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01337336
First received: April 15, 2011
Last updated: June 16, 2011
Last verified: June 2011
Results First Received: April 21, 2011  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Retrospective
Condition: Pulmonary Disease, Chronic Obstructive
Interventions: Drug: fluticasone propionate/salmeterol xinafoate
Drug: Anticholinergics

  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
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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
FSC Cohort Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
AC Cohort Anticholinergics (AC) include Tiotropium, Ipratropium, and Ipratropium-albuterol combination drug product. Due to the retrospective nature of this study, dosing information is not available.

Participant Flow:   Overall Study
    FSC Cohort     AC Cohort  
STARTED     1078     2923  
COMPLETED     1078     2923  
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.
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Reporting Groups
  Description
FSC Cohort Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
AC Cohort Anticholinergics (AC) include Tiotropium, Ipratropium, and Ipratropium-albuterol combination drug product. Due to the retrospective nature of this study, dosing information is not available.
Total Total of all reporting groups

Baseline Measures
    FSC Cohort     AC Cohort     Total  
Number of Participants  
[units: participants]
  1078     2923     4001  
Age  
[units: Years]
Mean ± Standard Deviation
  57.8  ± 9.8     60.3  ± 10.3     59.6  ± 10.2  
Gender  
[units: Participants]
     
Female     742     1910     2652  
Male     336     1013     1349  



  Outcome Measures
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1.  Primary:   Number of Participants With Any Chronic Obstructive Pulmonary Disease (COPD)-Related Exacerbation   [ Time Frame: Maximum of 1 year after index date (January 1, 2004 to June 30, 2009) ]

2.  Secondary:   Number of Participants With the Indicated COPD-related Exacerbations   [ Time Frame: Maximum of 1 year after index date (January 1, 2004 through June 30, 2009) ]

3.  Secondary:   Mean Annual COPD-related Costs Per Participant   [ Time Frame: Maximum of 1 year after index date (January 1, 2004 through June 30, 2009) ]

4.  Secondary:   Number of the Indicated COPD-related Exacerbations   [ Time Frame: Maximum of 1 year after index date (January 1, 2004 through June 30, 2009) ]


  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 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.


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: NCT01337336     History of Changes
Other Study ID Numbers: 113902
Study First Received: April 15, 2011
Results First Received: April 21, 2011
Last Updated: June 16, 2011
Health Authority: United States: No Health Authority