Outcomes for Medicare Asthma Patients Taking Fluticasone Propionate/Salmeterol Xinafoate Combination Versus Inhaled Corticosteroids or Other Combination Therapy

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fluticasone propionate/salmeterol xinafoate combination

Drug

Fluticasone propionate/salmeterol xinafoate combination for asthma, all doses (100mcg/50mcg, 250 mcg/50mcg and 500 mcg/50mcg)

Other names: Advair (TM)

Inhaled corticosteroids

Drug

Inhaled corticosteroids: beclomethasone dipropionte, mometasone, fluticasone propionate, budesonide, and flunisolide

Primary outcomes

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

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.

Secondary outcomes

Mean Asthma-related Costs in the Post-index Period

Time frame: Up to 7 years from July 1, 2001 to June 30, 2008

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

The number of albuterol canisters dispensed was used as a surrogate marker of asthma symptoms.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: May 4, 2011
Registry last updated: May 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed