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Trial record 72 of 318 for:    FLUTICASONE AND SALMETEROL

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

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ClinicalTrials.gov Identifier: NCT01381471
Recruitment Status : Completed
First Posted : June 27, 2011
Results First Posted : March 7, 2012
Last Update Posted : March 29, 2012
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Retrospective
Condition Pulmonary Disease, Chronic Obstructive
Intervention Drug: fluticasone propionate/salmeterol xinafoate combination
Enrollment 11060
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Fluticasone Propionate/Salmeterol (FSC)
Hide Arm/Group Description 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)
Period Title: Overall Study
Started 11060
Completed 11060
Not Completed 0
Arm/Group Title Fluticasone Propionate/Salmeterol (FSC)
Hide Arm/Group Description 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)
Overall Number of Baseline Participants 11060
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11060 participants
61.6  (9.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11060 participants
Female
6103
  55.2%
Male
4957
  44.8%
Number of Participants with the Indicated Level of Adherence to FSC   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 11060 participants
Low adherence 2726
Medium adherence 3479
High adherence 4855
[1]
Measure Description: 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.
1.Primary Outcome
Title Mean Number of Pharmacy Claims by Participants During the Post-Index Period
Hide Description The mean number of pharmacy claims incurred by participants during the one-year post-index period was measured.
Time Frame One Year
Hide Outcome Measure Data
Hide Analysis Population Description
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 COPD (ICD-9 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)
Arm/Group Title Fluticasone Propionate/Salmeterol (FSC)
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 11060
Mean (Standard Deviation)
Unit of Measure: pharmacy claims
Albuterol Pharmacy Claims 2.960  (4.627)
Inhaled Corticosteriod Pharmacy Claims 0.219  (1.092)
Anticholinergic Pharmacy Claims 5.491  (5.397)
Theophylline Pharmacy Claims 0.573  (2.188)
Oral Corticosteriod Pharmacy Claims 1.545  (2.727)
Antibiotic Pharmacy Claims 2.181  (2.743)
2.Primary Outcome
Title Mean Number of Healthcare Encounters Incurred by Participants During the Post-Index Period
Hide Description The mean number of outpatient office visits, inpatient visits, and emergency department visits incurred by participants during the one-year post-index period was measured.
Time Frame One Year
Hide Outcome Measure Data
Hide Analysis Population Description
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 COPD (ICD-9 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)
Arm/Group Title Fluticasone Propionate/Salmeterol (FSC)
Hide Arm/Group Description:
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)
Overall Number of Participants Analyzed 11060
Mean (Standard Deviation)
Unit of Measure: healthcare encounters
Outpatient Office Visits 2.048  (2.918)
Emergency Department Visits 0.145  (0.788)
Inpatient Visits 0.078  (0.353)
Time Frame [Not Specified]
Adverse Event Reporting Description This is a retrospective study of pre-existing medical record and/or health insurance claims data; all data are de-identified, and thus no assessments of Serious or Non-serious Adverse Events are possible.
 
Arm/Group Title Fluticasone Propionate/Salmeterol (FSC)
Hide Arm/Group Description 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)
All-Cause Mortality
Fluticasone Propionate/Salmeterol (FSC)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Fluticasone Propionate/Salmeterol (FSC)
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fluticasone Propionate/Salmeterol (FSC)
Affected / at Risk (%)
Total   0/0 
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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01381471     History of Changes
Other Study ID Numbers: 113865
First Submitted: June 23, 2011
First Posted: June 27, 2011
Results First Submitted: February 2, 2012
Results First Posted: March 7, 2012
Last Update Posted: March 29, 2012