An observational study in Asthma, sponsored by GlaxoSmithKline. Completed. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2017-05-25.
Sponsored by GlaxoSmithKline · Observational
The objective of this study is to compare healthcare utilization and costs in Medicare-eligible asthma patients (aged >65) who receive fluticasone propionate/salmeterol xinafoate combination or inhaled corticosteroids in a typical clinical practice using a retrospective observational cohort study design of large managed care database. Outcomes on interest include asthma related severe exacerbations defined as asthma related emergency department visits, hospitalizations or combined emergency department/hospitalization. Other outcomes of interest include use of albuterol, oral corticosteroids and overall asthma related costs. Outcomes of interest will be compared between the two treatment cohorts (fluticasone propionate/salmeterol xinafoate combination or inhaled corticosteroids). Dichotomous outcomes (emergency visits, hospitalizations etc) will be compared using Cox regression hazards analysis assessing time to first event for each asthma related endpoint adjusting for differences in baseline demographics such as age, gender, previous asthma medication use, co morbidities, costs, and plan demographics. Total asthma related costs will also be compared using generalized linear models adjusting for baseline differences.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 17,448 is above the median of 150 across 970 observational studies indexed under Asthma.
Browse Asthma studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Medicare-eligible subjects age 65 years and older with a diagnosis of asthma being treated with an inhaled corticosteroid
Exclusion Criteria:
Asthma subjects at least 65 years of age enrolled in a large Medicare managed care health plan.
Drug: fluticasone propionate/salmeterol xinafoate combination · Drug: inhaled corticosteroids
Fluticasone propionate/salmeterol xinafoate combination for asthma, all doses (100mcg/50mcg, 250 mcg/50mcg and 500 mcg/50mcg)
Also known as: Advair (TM)
Inhaled corticosteroids: beclomethasone dipropionte, mometasone, fluticasone propionate, budesonide, and flunisolide
Mean Number of Post-index Asthma-related Events Measured Using Medical and Pharmacy Claims
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.
Time frame: Up to 7 years from July 1, 2001 to June 30, 2008
Mean Asthma-related Costs in the Post-index Period
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.
Time frame: Up to 7 years from July 1, 2001 to June 30, 2008
Mean Number of Albuterol (Short-acting β-Agonists) Canisters Dispensed Per Pharmacy Claim Per Participant
The number of albuterol canisters dispensed was used as a surrogate marker of asthma symptoms.
Time frame: Up to 7 years from July 1, 2001 to June 30, 2008
| Milestone | Fluticasone Propionate and Salmeterol | Inhaled Corticosteroids |
|---|---|---|
| Started | 9868 | 7580 |
| Completed | 9868 | 7580 |
| Not completed | 0 | 0 |
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.
| Asthma-related events | Fluticasone Propionate and Salmeterol | Inhaled Corticosteroids |
|---|---|---|
| Inpatient visits | 0.033 ± 0.21 | 0.046 ± 0.25 |
| Emergency department visits | 0.022 ± 0.18 | 0.027 ± 0.20 |
| Inpatient/emergency department visits | 0.05 ± 0.30 | 0.07 ± 0.35 |
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.
| United States dollars | Fluticasone Propionate and Salmeterol | Inhaled Corticosteroids |
|---|---|---|
| Medical Services Costs | 381 ± 2859 | 462 ± 2859 |
| Pharmacy Costs | 1128 ± 1077 | 939 ± 1125 |
| Total Asthma Costs | 1509 ± 3832 | 1401 ± 3151 |
The number of albuterol canisters dispensed was used as a surrogate marker of asthma symptoms.
| albuterol canisters | Fluticasone Propionate and Salmeterol | Inhaled Corticosteroids |
|---|---|---|
| Mean Number of Albuterol (Short-acting β-Agonists) Canisters Dispensed Per Pharmacy Claim Per Participant | 1.01 ± 2.26 | 1.5 ± 2.95 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fluticasone Propionate and Salmeterol | — | — | — |
| Inhaled Corticosteroids | — | — | — |
| Age, Customized(Participants) | Fluticasone Propionate and Salmeterol | Inhaled Corticosteroids | Total |
|---|---|---|---|
| 65-69 years old | 4153 | 3064 | 7217 |
| 70-74 years old | 2694 | 2669 | 5363 |
| 75-79 years old | 3021 | 1847 | 4868 |
| Sex: Female, Male(Participants) | Fluticasone Propionate and Salmeterol | Inhaled Corticosteroids | Total |
|---|---|---|---|
| Female | 6083 | 4800 | 10883 |
| Male | 3785 | 2780 | 6565 |
| Number of participants with comorbid COPD at baseline(participants) | Fluticasone Propionate and Salmeterol | Inhaled Corticosteroids | Total |
|---|---|---|---|
| Number | 9227 | 7153 | 16380 |
No study locations are listed for this record.
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