Flixonase Safety in Patients With Allergic Rhinitis (AR)

NCT01077609 | Completed

• 2 other identifiers: 111983WE50002
• Study Type: observational
• Target: 1
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Allergic rhinitis (AR) & Flixonase

Patients initiating treatment for allergic rhinitis on intranasal fluticasone propionate

Drug: Intermittent, sub-chronic and chronic Flixonase use

AR & prescription for intranasal steroid other than Flixonase

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

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

Interventions

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.

Allergic rhinitis (AR) & Flixonase

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.

AR & prescription for intranasal steroid other than Flixonase

Eligibility Criteria

• Age: 4 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The General Practice Research Database (GPRD). Patient records dated between January 1990 - January 2002 were used to develop the overall study cohort.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Condition Hierarchy (Ancestors)

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

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2010
• First Posted: March 1, 2010
• Study Start: January 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: July 31, 2013

Record last verified: 2013-07