Flixonase Safety in Patients With Allergic Rhinitis (AR)

Completed

• Conditions: Rhinitis, Allergic, Perennial
• Interventions: Drug: Intermittent, sub-chronic and chronic Flixonase use; Drug: Intermittent, sub-chronic and chronic use of intranasal steroids other than Flixonase

• Registration Number: NCT01077609
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2010-02-25
• Study First Submitted QC: 2010-02-25
• Study First Posted: 2010-03-01
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-30
• Last Update Posted: 2013-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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:

  1. All patients with at least one prescription for Flixonase
  2. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Allergic rhinitis (AR) & Flixonase	Intermittent, sub-chronic and chronic Flixonase use	Patients initiating treatment for allergic rhinitis on intranasal fluticasone propionate
AR & prescription for intranasal steroid other than Flixonase	Intermittent, sub-chronic and chronic use of intranasal steroids other than Flixonase	Random sample of patients initiating treatment for allergic rhinitis with an intranasal steroid other than Flixonase

Primary Outcome Measures

Name	Time	Method
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	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.