Last updated: 11/07/2018 04:17:23
Flixonase safety in patients with Allergic Rhinitis (AR)
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Cohort
Primary completion date:
Not applicable
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)
No location data available.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
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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