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Fluticasone Propionate-salmeterol Combination Adherence in Patients With Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01381471
First received: June 23, 2011
Last updated: March 15, 2012
Last verified: February 2012
Results First Received: February 2, 2012  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Retrospective
Condition: Pulmonary Disease, Chronic Obstructive
Intervention: Drug: fluticasone propionate/salmeterol xinafoate combination

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were not recruited or enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymized and were used to develop a cohort. All diagnoses and treatments are recorded in the course of routine medical practice.

Reporting Groups
  Description
Fluticasone Propionate/Salmeterol (FSC) Participants age 40 or older with at least one pharmacy claim for FSC, at least one medical claim with a primary or secondary diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (International Classification of Disease, 9th Revision [ICD-9], Clinical Modification codes 490.xx, 491.xx, 492.xx, or 496.xx), and at least one pharmacy claim for an anticholinergic medication but no diagnosis for cystic fibrosis (ICD-9 = 277.0x)

Participant Flow:   Overall Study
    Fluticasone Propionate/Salmeterol (FSC)  
STARTED     11060  
COMPLETED     11060  
NOT COMPLETED     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.
No text entered.

Reporting Groups
  Description
Fluticasone Propionate/Salmeterol (FSC) Participants age 40 or older with at least one pharmacy claim for FSC, at least one medical claim with a primary or secondary diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (International Classification of Disease, 9th Revision [ICD-9], Clinical Modification [ICD-9] codes 490.xx, 491.xx, 492.xx, or 496.xx), and at least one1 pharmacy claim for an anticholinergic medication but no diagnosis for cystic fibrosis (ICD-9 = 277.0x)

Baseline Measures
    Fluticasone Propionate/Salmeterol (FSC)  
Number of Participants  
[units: participants]
  11060  
Age  
[units: Years]
Mean ± Standard Deviation
  61.6  ± 9.4  
Gender  
[units: Participants]
 
Female     6103  
Male     4957  
Number of Participants with the Indicated Level of Adherence to FSC [1]
[units: participants]
 
Low adherence     2726  
Medium adherence     3479  
High adherence     4855  
[1] Adherence levels were defined by the number of pharmacy claims for each participant in the year following the index date (an FSC claim from (July 1, 2005 to June 30, 2006). Three or fewer claims for FSC was considered low adherence, medium adherence was defined as 4 to 8 claims, and high adherence was defined as nine or more pharmacy claims.



  Outcome Measures
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1.  Primary:   Mean Number of Pharmacy Claims by Participants During the Post-Index Period   [ Time Frame: One Year ]

2.  Primary:   Mean Number of Healthcare Encounters Incurred by Participants During the Post-Index Period   [ Time Frame: One Year ]


  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: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01381471     History of Changes
Other Study ID Numbers: 113865
Study First Received: June 23, 2011
Results First Received: February 2, 2012
Last Updated: March 15, 2012
Health Authority: United States: No Health Authority