Flixonase Safety in Patients With Allergic Rhinitis (AR)

This is an inception cohort study that analyses data from an administrative medical records database. The two inception cohorts are: 1) patients initiated on intranasal FP and 2) patients initiated on another INS (not FP). The candidates for the inception cohorts did not use any intranasal steroid in the year prior to initiation.

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Key information

Conditions

Rhinitis, Allergic, Perennial Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

4 year–85 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

Patient records dated between January 1990 - January 2002 were used to develop the overall study cohort. The cohort was composed of the following patients:

All patients with at least one prescription for Flixonase
A random sample of patients having at least one prescription for an INS other than Flixonase

Exclusion criteria

Patient-level exclusion

Patients with less than 180 days of continuous eligibility before index date
Patients who are under four years of age at index date
Patients who are older than 85 years of age at index date

Episode-level exclusion

-When patient history was divided into Flixonase or other INS use episodes, patients with less than 120 days of eligibility after the last prescription in the episode Patients with an event of interest 180 days prior to patients' entry into the cohort or anytime prior to an episode index date were automatically excluded from the analysis of that event. This exclusion criterion was applied to rule out prevalent conditions.

Treatment and study plan

Intermittent, sub-chronic and chronic Flixonase use

Drug

Intermittent exposure episode is a series of fewer than four sequential prescriptions for Flixonase with gaps of no more than 60 days between any two. Sub-chronic use episode is a series of at least four and not more than eight sequential prescriptions for Flixonase with gaps of no more than 60 days between any two. Chronic use episode is a series of at least nine sequential prescriptions for Flixonase and gaps of no more than 60 days between any two. A span of at least 180 days must occur between the first and last prescription.

Intermittent, sub-chronic and chronic use of intranasal steroids other than Flixonase

Drug

Intermittent exposure episode is a series of fewer than four sequential prescriptions for an intranasal steroid other than Flixonase with gaps of no more than 60 days between any two. Sub-chronic use episode is a series of at least four and not more than eight sequential prescriptions for an intranasal steroid other than Flixonase with gaps of no more than 60 days between any two. Chronic use episode is a series of at least nine sequential prescriptions for an intranasal steroid other than Flixonase and gaps of no more than 60 days between any two. A span of at least 180 days must occur between the first and last prescription.

Primary outcomes

Steroid-related outcomes: Cataracts, Glaucoma, Nasal septum perforation, Hypercorticism, Adrenal insufficiency, Fractures (limited to hip, wrist and vertebral as proxies for osteoporosis), Otitis media, Sinusitis, Infectious complications of sinusitis

Time frame: Exposure episodes are defined as any series of prescriptions filled within 60 days of one another. Observation periods capture incident events beginning with the first prescription in the episode and ending 120 days after the last fill date.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Fluticasone Propionate Nasal Spray (Flixonase) Safety in Patients With Allergic Rhinitis Registered in the UK General Practice Research Database

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2010
First posted: Mar 1, 2010
Registry last updated: Jul 31, 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.

Completed