Flixonase Safety in Patients With Allergic Rhinitis (AR)

NCT ID: NCT01077609

Last Updated: 2013-07-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2010-04-30

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.

Conditions

Rhinitis, Allergic, Perennial

Keywords

Intranasal steroids; beclometasone diproprionate; steroid-related outcomes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Allergic rhinitis (AR) & Flixonase

Patients initiating treatment for allergic rhinitis on intranasal fluticasone propionate

Intermittent, sub-chronic and chronic Flixonase use

Intervention Type: 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.

AR & prescription for intranasal steroid other than Flixonase

Random sample of patients initiating treatment for allergic rhinitis with an intranasal steroid other than Flixonase

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

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

WE50002

Identifier Type: -

Identifier Source: secondary_id

111983

Identifier Type: -

Identifier Source: org_study_id