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

February 25, 2010
July 30, 2013
January 2008
April 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01077609 on ClinicalTrials.gov Archive Site
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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

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.

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Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Probability Sample

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

Rhinitis, Allergic, Perennial
  • 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.
  • Allergic rhinitis (AR) & Flixonase
    Patients initiating treatment for allergic rhinitis on intranasal fluticasone propionate
    Intervention: 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
    Intervention: Drug: Intermittent, sub-chronic and chronic use of intranasal steroids other than Flixonase
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1
April 2010
April 2010   (final data collection date for primary outcome measure)

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.

Both
4 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT01077609
111983, WE50002
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP