Flixonase Safety in Patients With Allergic Rhinitis (AR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01077609
First received: February 25, 2010
Last updated: July 30, 2013
Last verified: July 2013
  Purpose

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 Intervention
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 Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Enrollment: 1
Study Start Date: January 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   4 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01077609

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01077609     History of Changes
Other Study ID Numbers: 111983, WE50002
Study First Received: February 25, 2010
Last Updated: July 30, 2013
Health Authority: United States: No Health Authority

Keywords provided by GlaxoSmithKline:
Intranasal steroids
beclometasone diproprionate
steroid-related outcomes

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections
Fluticasone
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014