Last updated: 11/03/2018 17:18:07
A comparison of patients on AVAMYS ® versus NASONEX (A trade mark of Schering Corporation) and FLIXONASE ® on Key Health Outcome Measures
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: A comparison of patients on AVAMYS ® versus NASONEX (A trade mark of Schering Corporation) and FLIXONASE ® on Key Health Outcome Measures
Trial description: Previous publications have indicated that Allergic Rhinitis (AR) patients suffering from both ocular and nasal symptoms have a greater burden of illness and lower quality of life than patients suffering from nasal symptoms alone. Fluticasone furoate (FF) acts against both nasal and ocular symptoms. The purpose of this study was to evaluate the differences in symptom control (both perceptually and objectively) and resource use for patients with current seasonal AR.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Evaluate the differences in Symtom Free Days (SFD) in patients receiving FF, MF or FP
Timeframe: 4 weeks
Secondary outcomes:
Evaluate the differences in Quality of Life (mini-Rhinoconjunctivitis Quality of Life Questionnaire) in patients receiving FF, MF or FP
Timeframe: 4 weeks
Evaluate the differences in the number of AR treatments used by patients receiving FF, MF or FP
Timeframe: 4 weeks
Evaluate the differences in the number of non-prescribed treatments used by patients receiving FF, MF or FP
Timeframe: 4 weeks
Evaluate the differences in the cost of non-prescribed treatments used by patients receiving FF, MF or FP
Timeframe: 4 weeks
Evaluate the differences in the Pittsburgh Sleep Quality Index in patients receiving FF, MF or FP
Timeframe: 4 weeks
Evaluate the differences in productivitiy (Work Productivity and Activity Impairment Questionnaire) of patients receiving FF, MF or FP
Timeframe: 4 weeks
Evaluate the differences in number of work day lost by patients receiving FF, MF or FP
Timeframe: 4 weeks
Evaluate the differences in the number of physician visits (as reported by patient and doctor) by patients receiving FF, MF or FP
Timeframe: 4 weeks
Interventions:
Drug: Fluticasone furoate
Drug: mometasone furoate
Drug: fluticasone propionate
Enrollment:
540
Observational study model:
Cohort
Primary completion date:
Not applicable
Time perspective:
Cross-Sectional
Clinical publications:
Gueron B; Demoly P; Piercy J; Small M. A comparison of patients on Avamys vs Nasonex and Flixonase for Quality of Life and Symptoms Free Days in 3 European countries [Poster 380]. Presented at: XXIXth Congress of the European Academy of Allergy and Clinical Immunology, June 2010, London
Higgin V; Kay S; Small M. Physician and patient survey of allergic rhinitis: methodology. Allergy 2007;62(Suppl. 85):6-8
Mark Small, James Piercy, Pascale Demoly, Helen Marsden. Burden of illness and quality of life in patients being treated for seasonal allergic rhinitis: a cohort survey. Clin Transl Allergy. 2013;3(1):33.
Medical condition
Rhinitis, Allergic, Perennial
Product
fluticasone furoate, fluticasone propionate
Collaborators
Adelphi Real World
Study date(s)
July 2009 to August 2009
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
No
- Patient Inclusion Criteria:
- Current Seasonal Allergic Rhinitis sufferer (based on physician judgement)
Inclusion and exclusion criteria
Inclusion criteria:
- Current Seasonal Allergic Rhinitis sufferer (based on physician judgement)
- Currently receiving prescribed INS treatment (no other treatment restrictions apply)
- Have consumed at least one full prescription on the specified INS treatment
- No comorbid Asthma or COPD diagnosis
- Informed Consent Exclusion Criteria:
- None specified
Patient Inclusion Criteria:
Trial location(s)
No location data available.
Study documents
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
2009-01-08
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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