Flixonase Safety in Patients With Allergic Rhinitis (AR)

• ClinicalTrials.gov Identifier: NCT01077609
• Recruitment Status: Completed
• First Posted: March 1, 2010
• Last Update Posted: July 31, 2013
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Study Description

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.

Condition or disease	Intervention/treatment
Rhinitis, Allergic, Perennial	Drug: Intermittent, sub-chronic and chronic Flixonase use; Drug: Intermittent, sub-chronic and chronic use of intranasal steroids other than Flixonase

Study Design

• Study Type: Observational
• Actual Enrollment: 1 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Fluticasone Propionate Nasal Spray (Flixonase) Safety in Patients With Allergic Rhinitis Registered in the UK General Practice Research Database
• Study Start Date: January 2008
• Actual Primary Completion Date: April 2010
• Actual Study Completion Date: April 2010

Groups and Cohorts

Group/Cohort	Intervention/treatment
Allergic rhinitis (AR) & Flixonase; Patients initiating treatment for allergic rhinitis on intranasal fluticasone propionate	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.
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; 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.

Outcome Measures

Primary Outcome Measures :

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 [ 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. ]

Eligibility Criteria

• Ages Eligible for Study: 4 Years to 85 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

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.

Contacts and Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

More Information

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT01077609
• Other Study ID Numbers: 111983; WE50002
• First Posted: March 1, 2010
• Last Update Posted: July 31, 2013
• Last Verified: July 2013

Keywords provided by GlaxoSmithKline:

Intranasal steroids; beclometasone diproprionate; steroid-related outcomes

Additional relevant MeSH terms:

Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Nose Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Fluticasone; Anti-Inflammatory Agents; Bronchodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Asthmatic Agents; Respiratory System Agents; Dermatologic Agents; Anti-Allergic Agents