NCT01077609

Flixonase Safety in Patients With Allergic Rhinitis (AR)

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 4 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rhinitis, Allergic, Perennial

Interventions

Type	Name	Description
DRUG	Intermittent, sub-chronic and chronic Flixonase use	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.
DRUG	Intermittent, sub-chronic and chronic use of intranasal steroids other than Flixonase	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.

Timeline

• Start date: 2008-01-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2010-03-01
• Last updated: 2013-07-31