Trial Outcomes & Findings for 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 (NCT NCT01381406)
NCT ID: NCT01381406
Last Updated: 2017-06-14
Results Overview
A severe exacerbation is defined as one with a primary diagnosis of COPD. A moderate exacerbation is an ED visit with a primary diagnosis of COPD, a physician visit with a diagnosis of COPD and a prescription for an oral corticosteroid, a physician visit with a diagnosis code for COPD and an antibiotic for respiratory infection, or physician administration of nebulized albuterol within 3 days of an office visit. Incidence rate is calculated by dividing the number of exacerbations by the number of person years. Person years adjust for different lengths of follow up for participants.
COMPLETED
3333 participants
Data were collected over a maximum period of 4 years
2017-06-14
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.
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.
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
2481
|
852
|
|
Overall Study
COMPLETED
|
2481
|
852
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Tiotropium Bromide (TIO)
n=2481 Participants
Patients receiving tiotropium bromide (TIO) at the index date within the study period.
|
TIO Plus FSC/Salmeterol Xinafoate in Combination (TIO + FSC)
n=852 Participants
Patients receiving TIO plus fluticasone propionate (FSC)/salmeterol xinafoate combination (TIO + FSC) at the time of the index date within the study period
|
Total
n=3333 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.1 Years
STANDARD_DEVIATION 10.9 • n=99 Participants
|
64.6 Years
STANDARD_DEVIATION 11.0 • n=107 Participants
|
65.7 Years
STANDARD_DEVIATION 10.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1166 Participants
n=99 Participants
|
399 Participants
n=107 Participants
|
1565 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1315 Participants
n=99 Participants
|
453 Participants
n=107 Participants
|
1768 Participants
n=206 Participants
|
|
Number of health care encounters, as a measure of resource utilization
Home oxygen therapy
|
801 number of encounters
n=99 Participants
|
248 number of encounters
n=107 Participants
|
1049 number of encounters
n=206 Participants
|
|
Number of health care encounters, as a measure of resource utilization
Intensive care unit stays for COPD
|
81 number of encounters
n=99 Participants
|
29 number of encounters
n=107 Participants
|
110 number of encounters
n=206 Participants
|
|
Number of health care encounters, as a measure of resource utilization
Severe exacerbation of COPD
|
360 number of encounters
n=99 Participants
|
175 number of encounters
n=107 Participants
|
535 number of encounters
n=206 Participants
|
|
Number of health care encounters, as a measure of resource utilization
Moderate exacerbation of COPD
|
2274 number of encounters
n=99 Participants
|
747 number of encounters
n=107 Participants
|
3021 number of encounters
n=206 Participants
|
|
Number of health care encounters, as a measure of resource utilization
Hospitalization for COPD
|
467 number of encounters
n=99 Participants
|
228 number of encounters
n=107 Participants
|
695 number of encounters
n=206 Participants
|
|
Number of health care encounters, as a measure of resource utilization
Emergency department visit for COPD
|
570 number of encounters
n=99 Participants
|
199 number of encounters
n=107 Participants
|
769 number of encounters
n=206 Participants
|
|
Mean number of health care encounters, as a measure of resource utilization
SABA containers
|
2.4 number of encounters
STANDARD_DEVIATION 5.0 • n=99 Participants
|
2.2 number of encounters
STANDARD_DEVIATION 5.4 • n=107 Participants
|
2.4 number of encounters
STANDARD_DEVIATION 5.1 • n=206 Participants
|
|
Mean number of health care encounters, as a measure of resource utilization
Oral corticosteriod prescriptions
|
2.1 number of encounters
STANDARD_DEVIATION 2.9 • n=99 Participants
|
1.9 number of encounters
STANDARD_DEVIATION 2.3 • n=107 Participants
|
2.0 number of encounters
STANDARD_DEVIATION 2.8 • n=206 Participants
|
|
Mean number of health care encounters, as a measure of resource utilization
Number of physician visits for COPD
|
3.3 number of encounters
STANDARD_DEVIATION 3.6 • n=99 Participants
|
2.9 number of encounters
STANDARD_DEVIATION 3.4 • n=107 Participants
|
3.2 number of encounters
STANDARD_DEVIATION 3.6 • n=206 Participants
|
PRIMARY outcome
Timeframe: Data were collected over a maximum period of 4 yearsPopulation: Managed care enrollees (aged \>40 years) with at least one COPD-related exacerbation at baseline and newly initiating therapy with TIO with or without the addition of FSC during the study enrollment period was the target population. The date of TIO-alone therapy or TIO+FSC add-on date was the index date.
A severe exacerbation is defined as one with a primary diagnosis of COPD. A moderate exacerbation is an ED visit with a primary diagnosis of COPD, a physician visit with a diagnosis of COPD and a prescription for an oral corticosteroid, a physician visit with a diagnosis code for COPD and an antibiotic for respiratory infection, or physician administration of nebulized albuterol within 3 days of an office visit. Incidence rate is calculated by dividing the number of exacerbations by the number of person years. Person years adjust for different lengths of follow up for participants.
Outcome measures
| Measure |
Tiotropium Bromide (TIO)
n=2481 Participants
Patients receiving tiotropium bromide (TIO) at the index date within the study period.
|
TIO Plus FSC/Salmeterol Xinafoate in Combination (TIO + FSC)
n=852 Participants
Patients receiving TIO plus fluticasone propionate (FSC)/salmeterol xinafoate combination (TIO + FSC) at the time of the index date within the study period
|
|---|---|---|
|
Incidence Rate Per 100 Person Years of Hospitalization or Emergency Department (ED) Visit Related to Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
Any exacerbation
|
95.58 exacerbations per 100 person years
|
75.38 exacerbations per 100 person years
|
|
Incidence Rate Per 100 Person Years of Hospitalization or Emergency Department (ED) Visit Related to Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
Severe exacerbation
|
7.86 exacerbations per 100 person years
|
5.06 exacerbations per 100 person years
|
|
Incidence Rate Per 100 Person Years of Hospitalization or Emergency Department (ED) Visit Related to Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
Moderate exacerbation
|
88.65 exacerbations per 100 person years
|
69.74 exacerbations per 100 person years
|
SECONDARY outcome
Timeframe: Data were collected over a maximum period of 4 yearsPopulation: Managed care enrollees (aged \>40 years) with at least one COPD-related exacerbation at baseline and newly initiating therapy with TIO with or without the addition of FSC during the study enrollment period was the target population. The date of TIO-alone therapy or TIO+FSC add-on date was the index date.
The mean costs of health care encounters adjusted to control for baseline differences between treatment groups and reported in 2008 United States dollars as calculated with the consumer price index (CPI) are presented. CPI is standard multiplier for adjusting the cost of goods and services to a single year. Total costs include pharmacy and medical costs. Medical costs were computed from the paid amounts of medical claims with a primary diagnosis code for COPD. COPD-related pharmacy costs were computed from paid amounts of COPD-related prescription medications.
Outcome measures
| Measure |
Tiotropium Bromide (TIO)
n=2481 Participants
Patients receiving tiotropium bromide (TIO) at the index date within the study period.
|
TIO Plus FSC/Salmeterol Xinafoate in Combination (TIO + FSC)
n=852 Participants
Patients receiving TIO plus fluticasone propionate (FSC)/salmeterol xinafoate combination (TIO + FSC) at the time of the index date within the study period
|
|---|---|---|
|
Adjusted Mean Monthly Costs Per COPD Patient by Treatment Group
Total costs
|
721 United States dollars
Interval 190.0 to 2005.0
|
721 United States dollars
Interval 149.0 to 2250.0
|
|
Adjusted Mean Monthly Costs Per COPD Patient by Treatment Group
Pharmacy Costs
|
190 United States dollars
Interval 67.0 to 379.0
|
223 United States dollars
Interval 62.0 to 490.0
|
|
Adjusted Mean Monthly Costs Per COPD Patient by Treatment Group
Medical costs
|
543 United States dollars
Interval 66.0 to 3543.0
|
490 United States dollars
Interval 42.0 to 4004.0
|
SECONDARY outcome
Timeframe: Data were collected over a maximum period of 4 yearsPopulation: Managed care enrollees (aged \>40 years) with at least one COPD-related exacerbation at baseline and newly initiating therapy with TIO with or without the addition of FSC during the study enrollment period was the target population. The date of TIO-alone therapy or TIO+FSC add-on date was the index date.
Unadjusted incidence rates per 100 person years of chronic obstructive pulmonary disease (COPD)-related hospitalizations and emergency department visits by treatment group are presented. Incidence rate is calculated by dividing the number of healthcare service encounters by the number of person years of follow up. Person years adjust for different lengths of follow up for individual participants
Outcome measures
| Measure |
Tiotropium Bromide (TIO)
n=2481 Participants
Patients receiving tiotropium bromide (TIO) at the index date within the study period.
|
TIO Plus FSC/Salmeterol Xinafoate in Combination (TIO + FSC)
n=852 Participants
Patients receiving TIO plus fluticasone propionate (FSC)/salmeterol xinafoate combination (TIO + FSC) at the time of the index date within the study period
|
|---|---|---|
|
Incidence Rate of Hospitalizations and Emergency Room Visits Per 100 Person Years
COPD-related hospital and emergency room visits
|
95.58 visits per 100 person years
|
75.38 visits per 100 person years
|
|
Incidence Rate of Hospitalizations and Emergency Room Visits Per 100 Person Years
Hospitalizations
|
11.14 visits per 100 person years
|
7.43 visits per 100 person years
|
|
Incidence Rate of Hospitalizations and Emergency Room Visits Per 100 Person Years
Emergency department visits
|
12.63 visits per 100 person years
|
9.90 visits per 100 person years
|
Adverse Events
Tiotropium Bromide (TIO)
TIO Plus FSC/Salmeterol Xinafoate in Combination (TIO + FSC)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
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