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

GSK study ID
114812
See study documents
Clinicaltrials.gov ID
NCT01199757
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: 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
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    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:

      Patient 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

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    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
    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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