Trial Outcomes & Findings for Outcomes From Initial Maintenance Therapy With Fluticasone Propionate 250/Salmeterol 50 (FSC) or Tiotropium in Chronic Obstructive Pulmonary Disease (NCT NCT01387178)
NCT ID: NCT01387178
Last Updated: 2017-05-17
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
22223 participants
Primary outcome timeframe
1 year
Results posted on
2017-05-17
Participant Flow
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.
Participant milestones
| Measure |
Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg
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)
|
Tiotropium Bromide 18 µg
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)
|
|---|---|---|
|
Overall Study
STARTED
|
11582
|
10641
|
|
Overall Study
COMPLETED
|
11582
|
10641
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Outcomes From Initial Maintenance Therapy With Fluticasone Propionate 250/Salmeterol 50 (FSC) or Tiotropium in Chronic Obstructive Pulmonary Disease
Baseline characteristics by cohort
| Measure |
Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg
n=11582 Participants
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
|
Tiotropium Bromide 18 µg
n=10641 Participants
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
n=22223 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.8 Years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
63.1 Years
STANDARD_DEVIATION 10.0 • n=7 Participants
|
61.9 Years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6121 Participants
n=5 Participants
|
4958 Participants
n=7 Participants
|
11079 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5461 Participants
n=5 Participants
|
5683 Participants
n=7 Participants
|
11144 Participants
n=5 Participants
|
|
Region of Enrollment
Northeast
|
4523 Participants
n=5 Participants
|
4149 Participants
n=7 Participants
|
8672 Participants
n=5 Participants
|
|
Region of Enrollment
South
|
3818 Participants
n=5 Participants
|
3630 Participants
n=7 Participants
|
7448 Participants
n=5 Participants
|
|
Region of Enrollment
Midwest
|
1790 Participants
n=5 Participants
|
1731 Participants
n=7 Participants
|
3521 Participants
n=5 Participants
|
|
Region of Enrollment
West
|
1085 Participants
n=5 Participants
|
827 Participants
n=7 Participants
|
1912 Participants
n=5 Participants
|
|
Region of Enrollment
National or Unknown
|
366 Participants
n=5 Participants
|
304 Participants
n=7 Participants
|
670 Participants
n=5 Participants
|
|
Number of participants with the indicated payer source
Commercial
|
10233 participants
n=5 Participants
|
9227 participants
n=7 Participants
|
19460 participants
n=5 Participants
|
|
Number of participants with the indicated payer source
Medicaid
|
121 participants
n=5 Participants
|
50 participants
n=7 Participants
|
171 participants
n=5 Participants
|
|
Number of participants with the indicated payer source
Medicare
|
1228 participants
n=5 Participants
|
1364 participants
n=7 Participants
|
2592 participants
n=5 Participants
|
|
Charlson Comorbidity Score
|
1.6 scores on a scale
STANDARD_DEVIATION 2.1 • n=5 Participants
|
1.6 scores on a scale
STANDARD_DEVIATION 2.2 • n=7 Participants
|
1.6 scores on a scale
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
Number of the Indicated Pre-Index Period COPD-related comorbidities
Asthma
|
3326 number of comorbidities
n=5 Participants
|
1651 number of comorbidities
n=7 Participants
|
4977 number of comorbidities
n=5 Participants
|
|
Number of the Indicated Pre-Index Period COPD-related comorbidities
Congestive heart failure
|
1472 number of comorbidities
n=5 Participants
|
1624 number of comorbidities
n=7 Participants
|
3096 number of comorbidities
n=5 Participants
|
|
Number of the Indicated Pre-Index Period COPD-related comorbidities
Upper respiratory infection
|
4395 number of comorbidities
n=5 Participants
|
2952 number of comorbidities
n=7 Participants
|
7347 number of comorbidities
n=5 Participants
|
|
Number of the Indicated Pre-Index Period COPD-related comorbidities
Lower respiratory infection
|
531 number of comorbidities
n=5 Participants
|
475 number of comorbidities
n=7 Participants
|
1006 number of comorbidities
n=5 Participants
|
|
Number of the Indicated Pre-Index Period Treatments
Long-acting beta-agonist use
|
242 number of treatments
n=5 Participants
|
556 number of treatments
n=7 Participants
|
798 number of treatments
n=5 Participants
|
|
Number of the Indicated Pre-Index Period Treatments
Oxygen use
|
1210 number of treatments
n=5 Participants
|
1517 number of treatments
n=7 Participants
|
2727 number of treatments
n=5 Participants
|
|
Number of Participants with the Indicated COPD Severity
Mild
|
9442 participants
n=5 Participants
|
8476 participants
n=7 Participants
|
17918 participants
n=5 Participants
|
|
Number of Participants with the Indicated COPD Severity
Moderate
|
750 participants
n=5 Participants
|
520 participants
n=7 Participants
|
1270 participants
n=5 Participants
|
|
Number of Participants with the Indicated COPD Severity
Severe
|
1390 participants
n=5 Participants
|
1645 participants
n=7 Participants
|
3035 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: A subpopulation of participants with an index date between January 1, 2004 and September 30, 2007
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.
Outcome measures
| Measure |
Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg
n=7933 Participants
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
|
Tiotropium Bromide 18 µg
n=6372 Participants
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
|
|---|---|---|
|
Post-index Period COPD-related, Unadjusted Costs
Inpatient services
|
688 United States (US) dollars
Standard Deviation 4998
|
867 United States (US) dollars
Standard Deviation 6887
|
|
Post-index Period COPD-related, Unadjusted Costs
Emergency department visits
|
55 United States (US) dollars
Standard Deviation 415
|
52 United States (US) dollars
Standard Deviation 363
|
|
Post-index Period COPD-related, Unadjusted Costs
Inpatient and emergency department visits
|
743 United States (US) dollars
Standard Deviation 5090
|
919 United States (US) dollars
Standard Deviation 6977
|
|
Post-index Period COPD-related, Unadjusted Costs
Office visits
|
231 United States (US) dollars
Standard Deviation 388
|
293 United States (US) dollars
Standard Deviation 559
|
|
Post-index Period COPD-related, Unadjusted Costs
Other outpatient/ancillary services
|
734 United States (US) dollars
Standard Deviation 2504
|
879 United States (US) dollars
Standard Deviation 3050
|
|
Post-index Period COPD-related, Unadjusted Costs
Total medical costs
|
1709 United States (US) dollars
Standard Deviation 6322
|
2091 United States (US) dollars
Standard Deviation 8302
|
|
Post-index Period COPD-related, Unadjusted Costs
Total pharmacy costs
|
1291 United States (US) dollars
Standard Deviation 1791
|
1209 United States (US) dollars
Standard Deviation 1378
|
|
Post-index Period COPD-related, Unadjusted Costs
Total healthcare utilization
|
3000 United States (US) dollars
Standard Deviation 6805
|
3299 United States (US) dollars
Standard Deviation 8536
|
PRIMARY outcome
Timeframe: 1 yearPopulation: The total population including participants with index dates between January 1,2004 and June 30, 2008.
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.
Outcome measures
| Measure |
Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg
n=11582 Participants
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
|
Tiotropium Bromide 18 µg
n=10641 Participants
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
|
|---|---|---|
|
Mean Number of COPD Exacerbations
Moderate Exacerbation
|
0.35 number of exacerbations
Standard Deviation 0.77
|
0.29 number of exacerbations
Standard Deviation 0.71
|
|
Mean Number of COPD Exacerbations
Severe Exacerbation
|
0.05 number of exacerbations
Standard Deviation 0.29
|
0.05 number of exacerbations
Standard Deviation 0.32
|
|
Mean Number of COPD Exacerbations
Any Exacerbation
|
0.4 number of exacerbations
Standard Deviation 0.87
|
0.34 number of exacerbations
Standard Deviation 0.82
|
SECONDARY outcome
Timeframe: 1 yearPopulation: A subpopulation of participants with an index date between January 1, 2004 and September 30, 2007
Outcome measures
| Measure |
Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg
n=7933 Participants
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
|
Tiotropium Bromide 18 µg
n=6372 Participants
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
|
|---|---|---|
|
Number of COPD-related Healthcare Encounters
Inpatient services
|
2155 number of encounters
|
1792 number of encounters
|
|
Number of COPD-related Healthcare Encounters
Emergency department visits
|
3085 number of encounters
|
2312 number of encounters
|
|
Number of COPD-related Healthcare Encounters
Inpatient and emergency department visits
|
3673 number of encounters
|
2817 number of encounters
|
|
Number of COPD-related Healthcare Encounters
Office visits
|
7833 number of encounters
|
6295 number of encounters
|
|
Number of COPD-related Healthcare Encounters
Other outpatient/ancillary services
|
7243 number of encounters
|
5859 number of encounters
|
Adverse Events
Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tiotropium Bromide 18 µg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER