Observed Outcomes Associated With Fluticasone Propionate/Salmeterol Xinafoate or Inhaled Corticosteroids in Asthma Patients

This is an observational retrospective analysis of linked pharmacy and medical claims data from IMS Health/Pharmetrics database. which is a comprehensive, de-identified United States (US) healthcare claims database that is representative of the non-elderly, insurance-carrying population, The total population is 35.4 million. The average length of follow-up is 2.7 years mean (2.2 years median).

Subjects will be identified in the database that have at least one ICD-9 diagnostic code (493.xx) for asthma and at least 1 asthma treatment within a 12-month period prior to the index use of fluticsasone propionate/salmeterol xinafoate or inhaled corticosteroids. Subjects will be followed in the database until they have the event of interest (asthma-related emergency department visit, hospitalization, or oral corticosteroid use or combination of asthma-related emergency department/hospitalization or asthma-related emergency department/hospitalization/oral corticosteroids) or until they are lost to follow up whichever comes first. Subjects can be censored if they leave the database, have the event of interest, or are dispensed another asthma controller other than the medication of interest. All outcomes will be assessed in the follow-up period. Time-dependent statistical models adjusting for differences in baseline (pre-index) asthma and patient demographics will be used to compare asthma events.

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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

12 year–65 year

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

One or more medical claims with a diagnosis (primary or secondary) of asthma (ICD-9-CM 493.XX) during study period;
One or more outpatient pharmacy claims during the study for one or more of the following "study medications":
Fluticasone propionate/salmeterol xinafoate 250 mcg/50 mcg or 100mcg/50mcg combinations
Fluticasone propionate 110 mcg or 220 mcg
One or more asthma exacerbations (asthma-related hospitalization or emergency department visit, oral corticosteriod prescription drug claim, or a combination of any of the above events) during the 12 months prior to the index date ("pre-index period") or
Five or more prescriptions for a short-acting beta agonist during the pre-index period.

Exclusion criteria

Patients with more than one of the study medications during the 3-month period beginning with the index date;
One or more prescriptions within three months of index date (pre or post) for an ICS or LABA other than the study medications
One or more prescriptions within three months of post index date for:
Any asthma maintenance medication
Any medical claims during study period with a diagnosis of: Chronic obstructive pulmonary disease (COPD) (ICD-9-CM 491, 492, or 496); or Respiratory tract cancer (ICD-9-CM 160-164, or 231)

Treatment and study plan

Higher-dose inhaled corticosteroids

Drug

fluticasone propionate 110 or 220 mcg

Other names: Flovent® is a registered trademark of GlaxoSmithKline

Low-dose fixed dose fluticasone propionate/salmeterol xinafoate combination

Drug

Low dose inhaled corticosteroids/salmeterol xinafoate (100mcg/50mcg or 250 mcg/50mcg)

Other names: Advair ® is a registered trademark of GlaxoSmithKline

Primary outcomes

Asthma-related exacerbations

Time frame: Outcomes period is at least 90 days during 5-year study period

Asthma-related exacerbations contain resource utilization (ICD-9 code 493.xx) and/or asthma-related medications including asthma-related emergency department visit, hospitalization, or oral corticosteroid use or combination of asthma-related, emergency department/hospitalization or asthma-related, emergency department/hospitalization/oral corticosteroids

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Sep 12, 2011
Registry last updated: Feb 25, 2013

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.

Published trials that share one or more normalized conditions with this study.

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