Trial Outcomes & Findings for Outcomes for Medicare Asthma Patients Taking Fluticasone Propionate/Salmeterol Xinafoate Combination Versus Inhaled Corticosteroids or Other Combination Therapy (NCT NCT01347060)
NCT ID: NCT01347060
Last Updated: 2017-05-25
Results Overview
Asthma-related events were defined as events with any primary ICD-9 code of 493.xx for hospitalizations, emergency department visits, and combined hospitalization/emergency department visits. The post-index period is defined as 3-12 months after either the first administration of fluticasone propionate and salmetrol or inhaled corticosteroids. Medical and pharmacy claims are recorded healthcare encounters in a large managed care administrative insurance database.
COMPLETED
17448 participants
Up to 7 years from July 1, 2001 to June 30, 2008
2017-05-25
Participant Flow
Patients 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 patient cohort. All diagnoses and treatments are recorded in the course of routine medical practice.
Participant milestones
| Measure |
Fluticasone Propionate and Salmeterol
Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Fluticasone Propionate and Salmeterol 100 micrograms (mcg)/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg
|
Inhaled Corticosteroids
Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Inhaled Corticosteroids (beclomethasone dipropionate, fluticasone propionate, mometasone furoate, triamcinolone, flunisolide, budesoninde). Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
|
|---|---|---|
|
Overall Study
STARTED
|
9868
|
7580
|
|
Overall Study
COMPLETED
|
9868
|
7580
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Outcomes for Medicare Asthma Patients Taking Fluticasone Propionate/Salmeterol Xinafoate Combination Versus Inhaled Corticosteroids or Other Combination Therapy
Baseline characteristics by cohort
| Measure |
Fluticasone Propionate and Salmeterol
n=9868 Participants
Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Fluticasone Propionate and Salmeterol 100 micrograms (mcg)/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg
|
Inhaled Corticosteroids
n=7580 Participants
Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Inhaled Corticosteroids (beclomethasone dipropionate, fluticasone propionate, mometasone furoate, triamcinolone, flunisolide, budesoninde). Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
|
Total
n=17448 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
65-69 years old
|
4153 Participants
n=5 Participants
|
3064 Participants
n=7 Participants
|
7217 Participants
n=5 Participants
|
|
Age, Customized
70-74 years old
|
2694 Participants
n=5 Participants
|
2669 Participants
n=7 Participants
|
5363 Participants
n=5 Participants
|
|
Age, Customized
75-79 years old
|
3021 Participants
n=5 Participants
|
1847 Participants
n=7 Participants
|
4868 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6083 Participants
n=5 Participants
|
4800 Participants
n=7 Participants
|
10883 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3785 Participants
n=5 Participants
|
2780 Participants
n=7 Participants
|
6565 Participants
n=5 Participants
|
|
Number of participants with comorbid COPD at baseline
|
9227 participants
n=5 Participants
|
7153 participants
n=7 Participants
|
16380 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 7 years from July 1, 2001 to June 30, 2008Population: Participants contributing to the PharMetrics database (a large, multiplan insurance encounter database) who were identified in the study as having at least one pharmacy claim for fluticasone propionate/salmeterol or inhaled corticosteroids, had an ICD-9 code of 493.xx for asthma, and were at least 65 years of age within the time frame of the study.
Asthma-related events were defined as events with any primary ICD-9 code of 493.xx for hospitalizations, emergency department visits, and combined hospitalization/emergency department visits. The post-index period is defined as 3-12 months after either the first administration of fluticasone propionate and salmetrol or inhaled corticosteroids. Medical and pharmacy claims are recorded healthcare encounters in a large managed care administrative insurance database.
Outcome measures
| Measure |
Fluticasone Propionate and Salmeterol
n=9868 Participants
Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Fluticasone Propionate and Salmeterol 100 micrograms (mcg)/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg
|
Inhaled Corticosteroids
n=7580 Participants
Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Inhaled Corticosteroids (beclomethasone dipropionate, fluticasone propionate, mometasone furoate, triamcinolone, flunisolide, budesoninde). Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
|
|---|---|---|
|
Mean Number of Post-index Asthma-related Events Measured Using Medical and Pharmacy Claims
Inpatient visits
|
0.033 Asthma-related events
Standard Deviation 0.21
|
0.046 Asthma-related events
Standard Deviation 0.25
|
|
Mean Number of Post-index Asthma-related Events Measured Using Medical and Pharmacy Claims
Emergency department visits
|
0.022 Asthma-related events
Standard Deviation 0.18
|
0.027 Asthma-related events
Standard Deviation 0.20
|
|
Mean Number of Post-index Asthma-related Events Measured Using Medical and Pharmacy Claims
Inpatient/emergency department visits
|
0.05 Asthma-related events
Standard Deviation 0.30
|
0.07 Asthma-related events
Standard Deviation 0.35
|
SECONDARY outcome
Timeframe: Up to 7 years from July 1, 2001 to June 30, 2008Population: Participants contributing to the PharMetrics database (a large, multiplan insurance encounter database) who were identified in the study as having at least one pharmacy claim for fluticasone propionate/salmeterol or inhaled corticosteroids, had an ICD-9 code of 493.xx for asthma, and were at least 65 years of age within the time frame of the study.
Asthma-related costs were calculated as pharmacy costs, medical costs, and total asthma (pharmacy plus medical) costs. Medical costs were made up of asthma-related visits, hospitalizations, emergency department visits, and medical office visits. Pharmacy costs were comprised of all asthma-related medications used during the follow-up period. Medical services were identified by place of service and PharMetrics-specific confinement codes. Prescriptions were counted by 30-day fills, with fills less than 30 days rounded up to indicate one fill.
Outcome measures
| Measure |
Fluticasone Propionate and Salmeterol
n=9868 Participants
Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Fluticasone Propionate and Salmeterol 100 micrograms (mcg)/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg
|
Inhaled Corticosteroids
n=7580 Participants
Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Inhaled Corticosteroids (beclomethasone dipropionate, fluticasone propionate, mometasone furoate, triamcinolone, flunisolide, budesoninde). Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
|
|---|---|---|
|
Mean Asthma-related Costs in the Post-index Period
Medical Services Costs
|
381 United States dollars
Standard Deviation 2859
|
462 United States dollars
Standard Deviation 2859
|
|
Mean Asthma-related Costs in the Post-index Period
Pharmacy Costs
|
1128 United States dollars
Standard Deviation 1077
|
939 United States dollars
Standard Deviation 1125
|
|
Mean Asthma-related Costs in the Post-index Period
Total Asthma Costs
|
1509 United States dollars
Standard Deviation 3832
|
1401 United States dollars
Standard Deviation 3151
|
SECONDARY outcome
Timeframe: Up to 7 years from July 1, 2001 to June 30, 2008Population: Participants contributing to the PharMetrics database (a large, multiplan insurance encounter database) who were identified in the study as having at least one pharmacy claim for fluticasone propionate/salmeterol or inhaled corticosteroids, had an ICD-9 code of 493.xx for asthma, and were at least 65 years of age within the time frame of the study.
The number of albuterol canisters dispensed was used as a surrogate marker of asthma symptoms.
Outcome measures
| Measure |
Fluticasone Propionate and Salmeterol
n=9868 Participants
Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Fluticasone Propionate and Salmeterol 100 micrograms (mcg)/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg
|
Inhaled Corticosteroids
n=7580 Participants
Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Inhaled Corticosteroids (beclomethasone dipropionate, fluticasone propionate, mometasone furoate, triamcinolone, flunisolide, budesoninde). Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
|
|---|---|---|
|
Mean Number of Albuterol (Short-acting β-Agonists) Canisters Dispensed Per Pharmacy Claim Per Participant
|
1.01 albuterol canisters
Standard Deviation 2.26
|
1.5 albuterol canisters
Standard Deviation 2.95
|
Adverse Events
Fluticasone Propionate and Salmeterol
Inhaled Corticosteroids
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