Last updated: 11/07/2018 04:17:23

Flixonase safety in patients with Allergic Rhinitis (AR)

GSK study ID
111983
See study documents
Clinicaltrials.gov ID
NCT01077609
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Fluticasone propionate nasal spray (Flixonase) safety in patients with allergic rhinitis registered in the UK General Practice Research Database
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

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

Timeframe: 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.

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Intermittent, sub-chronic and chronic Flixonase use
  • Drug: Intermittent, sub-chronic and chronic use of intranasal steroids other than Flixonase
    • Enrollment:
    1
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Kourtney J. Davis, David Hinds, Stephen P. Motsko, Earl Goehring Jr, Judith K. Jones. Intranasal fluticasone propionate observational cohort safety studies: Reviewing evidence from databases on two continents. Drugs Reald World Outcomes. 2016;3(1):53-60
    Medical condition
    Rhinitis, Allergic, Perennial
    Product
    beclometasone, fluticasone furoate, fluticasone propionate
    Collaborators
    Not applicable
    Study date(s)
    January 2008 to April 2010
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    4 - 85 years
    Accepts healthy volunteers
    No
    • 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
    • Patient-level exclusion
    • Patients with less than 180 days of continuous eligibility before index date
    Inclusion and exclusion 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.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2010-22-04

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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