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Impact of Initiating Tiotropium Alone Versus Initiating Tiotropium in Combination With Fluticasone Propionate/Salmeterol Xinafoate Combination (FSC) on Chronic Obstructive Pulmonary Disease-related Outcomes in Patients With Pre-existing Exacerbations

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01381406
First received: June 23, 2011
Last updated: September 15, 2011
Last verified: June 2011
Results First Received: September 15, 2011  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Retrospective
Condition: Pulmonary Disease, Chronic Obstructive
Interventions: Drug: TIO
Drug: TIO+FSC

  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
Participants were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymized and used to develop a cohort. All diagnoses and treatments are recorded in the course of routine medical practice.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were treated with tiotropium bromide (TIO) or tiotropium bromide plus fluticasone propionate/salmeterol xinafoate combination (TIO + FSC) by their practitioners, and the database included information about their healthcare encounters.

Reporting Groups
  Description
Tiotropium Bromide (TIO) Patients receiving tiotropium bromide (TIO) at the index date within the study period
TIO Plus FSC/Salmeterol Xinafoate in Combination (TIO + FSC) Patients receiving TIO plus fluticasone propionate (FSC)/salmeterol xinafoate combination (TIO + FSC) at the time of the index date within the study period

Participant Flow:   Overall Study
    Tiotropium Bromide (TIO)   TIO Plus FSC/Salmeterol Xinafoate in Combination (TIO + FSC)
STARTED   2481   852 
COMPLETED   2481   852 
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
Tiotropium Bromide (TIO) Patients receiving tiotropium bromide (TIO) at the index date within the study period.
TIO Plus FSC/Salmeterol Xinafoate in Combination (TIO + FSC) Patients receiving TIO plus fluticasone propionate (FSC)/salmeterol xinafoate combination (TIO + FSC) at the time of the index date within the study period
Total Total of all reporting groups

Baseline Measures
   Tiotropium Bromide (TIO)   TIO Plus FSC/Salmeterol Xinafoate in Combination (TIO + FSC)   Total 
Overall Participants Analyzed 
[Units: Participants]
 2481   852   3333 
Age 
[Units: Years]
Mean (Standard Deviation)
 66.1  (10.9)   64.6  (11.0)   65.7  (10.9) 
Gender 
[Units: Participants]
     
Female   1166   399   1565 
Male   1315   453   1768 
Number of health care encounters, as a measure of resource utilization [1] 
[Units: Number of encounters]
     
Home oxygen therapy   801   248   1049 
Intensive care unit stays for COPD   81   29   110 
Severe exacerbation of COPD   360   175   535 
Moderate exacerbation of COPD   2274   747   3021 
Hospitalization for COPD   467   228   695 
Emergency department visit for COPD   570   199   769 
[1] The number of health care encounters for each participant group was measured. COPD = Chronic Obstructive Pulmonary Disease. An exacerbation of COPD is defined as an emergency department visit and a primary COPD diagnosis code or a physician visit plus COPD prescription (moderate) or hospitalization with a primary diagnosis of COPD (severe).
Mean number of health care encounters, as a measure of resource utilization [1] 
[Units: Number of encounters]
Mean (Standard Deviation)
     
SABA containers   2.4  (5.0)   2.2  (5.4)   2.4  (5.1) 
Oral corticosteriod prescriptions   2.1  (2.9)   1.9  (2.3)   2.0  (2.8) 
Number of physician visits for COPD   3.3  (3.6)   2.9  (3.4)   3.2  (3.6) 
[1] The mean number of health care encounters for each participant group was measured. COPD = Chronic Obstructive Pulmonary Disease. SABA = Short Acting Beta Agonist.


  Outcome Measures
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1.  Primary:   Incidence Rate Per 100 Person Years of Hospitalization or Emergency Department (ED) Visit Related to Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)   [ Time Frame: Data were collected over a maximum period of 4 years ]

2.  Secondary:   Adjusted Mean Monthly Costs Per COPD Patient by Treatment Group   [ Time Frame: Data were collected over a maximum period of 4 years ]

3.  Secondary:   Incidence Rate of Hospitalizations and Emergency Room Visits Per 100 Person Years   [ Time Frame: Data were collected over a maximum period of 4 years ]


  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: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01381406     History of Changes
Other Study ID Numbers: 111266
Study First Received: June 23, 2011
Results First Received: September 15, 2011
Last Updated: September 15, 2011