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

NCT01347060 | Completed Results

• 1 other identifier: 112605
• Study Type: observational
• Target: 17,448
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Asthma

Keywords

Asthma; treatment; Advair and inhaled corticosteroids; Medicare; Outcomes; costs

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (2)

• Mean Asthma-related Costs in the Post-index Period

  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

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

Study Arms (1)

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; Drug: inhaled corticosteroids

Interventions

fluticasone propionate/salmeterol xinafoate combination DRUG

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

Also known as: Advair (TM)

Medicare-eligible subjects with asthma

inhaled corticosteroids DRUG

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

Medicare-eligible subjects with asthma

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Medicare-eligible subjects age 65 years and older with a diagnosis of asthma being treated with an inhaled corticosteroid

You may qualify if:

• Subjects with asthma as determined by ICD-9 codes and asthma drug use
• at least 65 years of age
• prescription for an inhaled corticosteroid

You may not qualify if:

• a diagnosis of chronic obstructive pulmonary disease or
• a prescription for a chronic obstructive pulmonary disease treatment

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone-Salmeterol Drug Combination

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Salmeterol Xinafoate; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Fluticasone; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2010
• First Posted: May 4, 2011
• Study Start: July 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: May 25, 2017
• Results First Posted: June 1, 2011

Record last verified: 2017-05