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Outcomes From Initial Maintenance Therapy With Fluticasone Propionate 250/Salmeterol 50 (FSC) or Tiotropium in Chronic Obstructive Pulmonary Disease

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ClinicalTrials.gov Identifier: NCT01387178
Recruitment Status : Completed
First Posted : July 4, 2011
Results First Posted : October 28, 2011
Last Update Posted : May 17, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Retrospective
Condition Pulmonary Disease, Chronic Obstructive
Interventions Drug: fluticasone propionate/salmeterol 250µg/50µg (FSC)
Drug: tiotropium bromide (TIO)
Enrollment 22223
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg Tiotropium Bromide 18 µg
Hide Arm/Group Description Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (International Classification of Disease, 9th Edition, Clinical Modification [ICD-9-CM] code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for fluticasone/propionate 250 µg /50 µg (FSC) Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for tiotropium bromide (TIO)
Period Title: Overall Study
Started 11582 10641
Completed 11582 10641
Not Completed 0 0
Arm/Group Title Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg Tiotropium Bromide 18 µg Total
Hide Arm/Group Description Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for FSC Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for TIO Total of all reporting groups
Overall Number of Baseline Participants 11582 10641 22223
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11582 participants 10641 participants 22223 participants
60.8  (10.6) 63.1  (10.0) 61.9  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11582 participants 10641 participants 22223 participants
Female
6121
  52.8%
4958
  46.6%
11079
  49.9%
Male
5461
  47.2%
5683
  53.4%
11144
  50.1%
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 11582 participants 10641 participants 22223 participants
Northeast 4523 4149 8672
South 3818 3630 7448
Midwest 1790 1731 3521
West 1085 827 1912
National or Unknown 366 304 670
[1]
Measure Description: Some participants are grouped into the “National” region to protect their identities because the combination of their medical and demographic information is considered “infrequent” and could potentially be used to identify the participants.
Number of participants with the indicated payer source   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 11582 participants 10641 participants 22223 participants
Commercial 10233 9227 19460
Medicaid 121 50 171
Medicare 1228 1364 2592
[1]
Measure Description: Participants were classified according to the type of healthcare payer with which they were associated.
Charlson Comorbidity Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 11582 participants 10641 participants 22223 participants
1.6  (2.1) 1.6  (2.2) 1.6  (2.1)
[1]
Measure Description: The Charlson Comorbidity Index estimates 10-year mortality risk. Scores range from 0 - 37, with a lower score indicating a higher chance of survival.
Number of the Indicated Pre-Index Period COPD-related comorbidities   [1] 
Measure Type: Number
Unit of measure:  Number of comorbidities
Number Analyzed 11582 participants 10641 participants 22223 participants
Asthma 3326 1651 4977
Congestive heart failure 1472 1624 3096
Upper respiratory infection 4395 2952 7347
Lower respiratory infection 531 475 1006
[1]
Measure Description: The pre-index period was defined as the 12 months prior to the index date, which corresponded with the start of the study medication.
Number of the Indicated Pre-Index Period Treatments  
Measure Type: Number
Unit of measure:  Number of treatments
Number Analyzed 11582 participants 10641 participants 22223 participants
Long-acting beta-agonist use 242 556 798
Oxygen use 1210 1517 2727
Number of Participants with the Indicated COPD Severity   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 11582 participants 10641 participants 22223 participants
Mild 9442 8476 17918
Moderate 750 520 1270
Severe 1390 1645 3035
[1]
Measure Description: Mild, moderate, and severe COPD were defined by an algorithm for retrospective data analyses that is based on COPD-related healthcare encounters such as intensive care unit stays, hospitalizations, emergency department/urgent care visits, and the use of oxygen.
1.Primary Outcome
Title Post-index Period COPD-related, Unadjusted Costs
Hide Description The mean cost per participant for COPD-related healthcare interventions for one year following the index date (first pharmacy claim for fluticasone propionate/salmeterol 250 µg/50 µg [FSC] or tiotropium bromide [TIO]) was calculated. Total medical costs included inpatient, emergency department, and outpatient costs associated with the treatment of COPD. Total pharmacy costs included costs of all COPD-related medications, and total healthcare costs included all medical and pharmacy costs that were related to COPD treatment. These costs were unadjusted and reflect the actual costs.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
A subpopulation of participants with an index date between January 1, 2004 and September 30, 2007
Arm/Group Title Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg Tiotropium Bromide 18 µg
Hide Arm/Group Description:
Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for FSC
Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for TIO
Overall Number of Participants Analyzed 7933 6372
Mean (Standard Deviation)
Unit of Measure: United States (US) dollars
Inpatient services 688  (4998) 867  (6887)
Emergency department visits 55  (415) 52  (363)
Inpatient and emergency department visits 743  (5090) 919  (6977)
Office visits 231  (388) 293  (559)
Other outpatient/ancillary services 734  (2504) 879  (3050)
Total medical costs 1709  (6322) 2091  (8302)
Total pharmacy costs 1291  (1791) 1209  (1378)
Total healthcare utilization 3000  (6805) 3299  (8536)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean
Estimated Value 7451
Confidence Interval (2-Sided) 95%
5857 to 9045
Estimation Comments The mean predicted cost for inpatient services for participants treated with FSC. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tiotropium Bromide 18 µg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean
Estimated Value 11545
Confidence Interval (2-Sided) 95%
8827 to 14263
Estimation Comments The mean predicted cost for inpatient services for participants treated with TIO. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean
Estimated Value 61
Confidence Interval (2-Sided) 95%
58 to 63
Estimation Comments The mean predicted cost for emergency department visits for participants treated with FSC. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Tiotropium Bromide 18 µg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean
Estimated Value 51
Confidence Interval (2-Sided) 95%
49 to 53
Estimation Comments The mean predicted cost for emergency department visits for participants treated with TIO. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean
Estimated Value 231
Confidence Interval (2-Sided) 95%
227 to 234
Estimation Comments The mean predicted cost for office visits for participants treated with FSC. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Tiotropium Bromide 18 µg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean
Estimated Value 295
Confidence Interval (2-Sided) 95%
290 to 299
Estimation Comments The mean predicted cost for office visits for participants treated with TIO. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean
Estimated Value 873
Confidence Interval (2-Sided) 95%
827 to 919
Estimation Comments The mean predicted cost for other outpatient and ancillary services for FSC participants. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Tiotropium Bromide 18 µg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean
Estimated Value 1080
Confidence Interval (2-Sided) 95%
1022 to 1138
Estimation Comments The mean predicted cost for other outpatient and ancillary services for TIO participants. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean
Estimated Value 1267
Confidence Interval (2-Sided) 95%
1251 to 1283
Estimation Comments The mean predicted cost for pharmacy services for participants treated with FSC. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Tiotropium Bromide 18 µg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean
Estimated Value 1250
Confidence Interval (2-Sided) 95%
1234 to 1266
Estimation Comments The mean predicted cost for pharmacy services for participants treated with TIO. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean
Estimated Value 1175
Confidence Interval (2-Sided) 95%
1083 to 1267
Estimation Comments The mean predicted cost for inpatient and emergency department services for FSC participants. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Tiotropium Bromide 18 µg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean
Estimated Value 1566
Confidence Interval (2-Sided) 95%
1438 to 1695
Estimation Comments The mean predicted cost for inpatient and emergency department services for TIO participants. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean
Estimated Value 2991
Confidence Interval (2-Sided) 95%
2922 to 3059
Estimation Comments The mean predicted cost for total healthcare services for participants treated with FSC. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Tiotropium Bromide 18 µg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean
Estimated Value 3304
Confidence Interval (2-Sided) 95%
3221 to 3386
Estimation Comments The mean predicted cost for total healthcare services for participants treated with TIO. A generalized linear model with a log link function and gamma distribution for the error term to resolve the issue of skewed cost distribution was used.
2.Primary Outcome
Title Mean Number of COPD Exacerbations
Hide Description Moderate COPD exacerbations were defined as the occurrence of a COPD-related emergency department (ED) visit or a COPD-related office visit that is closely followed by a prescription claim for oral steroids or antibiotics. Severe exacerbations were defined as the occurrence of a COPD-related hospital admission.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
The total population including participants with index dates between January 1,2004 and June 30, 2008.
Arm/Group Title Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg Tiotropium Bromide 18 µg
Hide Arm/Group Description:
Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for FSC
Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for TIO
Overall Number of Participants Analyzed 11582 10641
Mean (Standard Deviation)
Unit of Measure: number of exacerbations
Moderate Exacerbation 0.35  (0.77) 0.29  (0.71)
Severe Exacerbation 0.05  (0.29) 0.05  (0.32)
Any Exacerbation 0.4  (0.87) 0.34  (0.82)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg, Tiotropium Bromide 18 µg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2198
Comments Risk of Moderate COPD Exacerbations
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.964
Confidence Interval 95%
0.909 to 1.022
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg, Tiotropium Bromide 18 µg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0406
Comments Risk of Severe COPD Exacerbations
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.864
Confidence Interval 95%
0.752 to 0.994
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg, Tiotropium Bromide 18 µg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0962
Comments Risk of Any COPD Exacerbation
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.953
Confidence Interval 95%
0.901 to 1.009
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of COPD-related Healthcare Encounters
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
A subpopulation of participants with an index date between January 1, 2004 and September 30, 2007
Arm/Group Title Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg Tiotropium Bromide 18 µg
Hide Arm/Group Description:
Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for FSC
Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for TIO
Overall Number of Participants Analyzed 7933 6372
Measure Type: Number
Unit of Measure: number of encounters
Inpatient services 2155 1792
Emergency department visits 3085 2312
Inpatient and emergency department visits 3673 2817
Office visits 7833 6295
Other outpatient/ancillary services 7243 5859
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 250 Micrograms (µg)/50 µg Tiotropium Bromide 18 µg
Hide Arm/Group Description Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for FSC Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for TIO
All-Cause Mortality
Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg Tiotropium Bromide 18 µg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg Tiotropium Bromide 18 µg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg Tiotropium Bromide 18 µg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   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: NCT01387178     History of Changes
Other Study ID Numbers: 111267
First Submitted: June 16, 2011
First Posted: July 4, 2011
Results First Submitted: September 21, 2011
Results First Posted: October 28, 2011
Last Update Posted: May 17, 2017