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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:
ClinicalTrials.gov Identifier:
NCT01337336
First Posted: April 18, 2011
Last Update Posted: May 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
Results First Submitted: 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 
Overall Participants Analyzed 
[Units: Participants]
 1078   2923   4001 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.8  (9.8)   60.3  (10.3)   59.6  (10.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      742  68.8%      1910  65.3%      2652  66.3% 
Male      336  31.2%      1013  34.7%      1349  33.7% 


  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



Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01337336     History of Changes
Other Study ID Numbers: 113902
First Submitted: April 15, 2011
First Posted: April 18, 2011
Results First Submitted: April 21, 2011
Results First Posted: May 20, 2011
Last Update Posted: May 30, 2017