Outcomes for Medicare Asthma Patients Taking Fluticasone Propionate/Salmeterol Xinafoate Combination Versus Inhaled Corticosteroids or Other Combination Therapy
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Asthma |
Drug: fluticasone propionate/salmeterol xinafoate combination Drug: inhaled corticosteroids |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Outcomes for Medicare Asthma Patients Taking Fluticasone Propionate/Salmeterol Xinafoate Combination Versus Inhaled Corticosteroids or Other Combination Therapy |
- Mean Number of Post-index Asthma-related Events Measured Using Medical and Pharmacy Claims [ Time Frame: Up to 7 years from July 1, 2001 to June 30, 2008 ] [ Designated as safety issue: No ]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.
- Mean Asthma-related Costs in the Post-index Period [ Time Frame: Up to 7 years from July 1, 2001 to June 30, 2008 ] [ Designated as safety issue: No ]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.
- Mean Number of Albuterol (Short-acting β-Agonists) Canisters Dispensed Per Pharmacy Claim Per Participant [ Time Frame: Up to 7 years from July 1, 2001 to June 30, 2008 ] [ Designated as safety issue: No ]The number of albuterol canisters dispensed was used as a surrogate marker of asthma symptoms.
| Enrollment: | 17448 |
| Study Start Date: | July 2009 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Medicare-eligible subjects with asthma
Asthma subjects at least 65 years of age enrolled in a large Medicare managed care health plan.
|
Drug: fluticasone propionate/salmeterol xinafoate combination
Fluticasone propionate/salmeterol xinafoate combination for asthma, all doses (100mcg/50mcg, 250 mcg/50mcg and 500 mcg/50mcg)
Other Name: Advair (TM)
Drug: inhaled corticosteroids
Inhaled corticosteroids: beclomethasone dipropionte, mometasone, fluticasone propionate, budesonide, and flunisolide
|
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Medicare-eligible subjects age 65 years and older with a diagnosis of asthma being treated with an inhaled corticosteroid
Inclusion Criteria:
- Subjects with asthma as determined by ICD-9 codes and asthma drug use
- at least 65 years of age
- prescription for an inhaled corticosteroid
Exclusion Criteria:
- a diagnosis of chronic obstructive pulmonary disease or
- a prescription for a chronic obstructive pulmonary disease treatment
Contacts and Locations More Information
No publications provided
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT01347060 History of Changes |
| Other Study ID Numbers: | 112605 |
| Study First Received: | June 10, 2010 |
| Results First Received: | May 5, 2011 |
| Last Updated: | July 28, 2011 |
| Health Authority: | United States: No Health Authority |
Keywords provided by GlaxoSmithKline:
|
Asthma treatment Advair and inhaled corticosteroids |
Medicare Outcomes costs |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Salmeterol Albuterol Fluticasone Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists |
Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Tocolytic Agents Reproductive Control Agents Dermatologic Agents Anti-Allergic Agents |
ClinicalTrials.gov processed this record on May 16, 2013