Last updated: 11/07/2018 16:52:04

Fluticasone Nasal Spray Patient Preference Study

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GSK study ID
FFU108556
See study documents
Clinicaltrials.gov ID
NCT00398476
See results summary
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 Patient Preference Evaluation Study of Fluticasone Furoate Nasal Spray and Fluticasone Propionate Aqueous Nasal Spray in Subject with Allergic Rhinitis
Trial description: The objectives of this study are to evaluate and compare patient preference for FF (Fluticasone Furoate) and FP (Fluticasone Propionate Aqueous)nasal sprays in the treatment of allergic rhinitis following single-dose administration.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Overall Participants preference for nasal spray based on selected product attributes at the end of crossover dosing

Timeframe: Day 1

Secondary outcomes:

Number of participants with preference for scent/odor in IAQ and DAQ

Timeframe: Day 1

Number of participants with preference for satisfaction with scent/odor in IAQ

Timeframe: Day 1

Number of participants with preference for satisfaction with scent/odor in DAQ

Timeframe: Day 1

Number of participants who satisfied not to have scent/odor in IAQ

Timeframe: Day 1

Number of participants who satisfied not to have scent/odor in DAQ

Timeframe: Day 1

Number of participants reported product have an immediate taste in IAQ

Timeframe: Day 1

Number of participants satisfied with an immediate taste in IAQ

Timeframe: Day 1

Number of participants reported product have an after taste in DAQ

Timeframe: Day 1

Number of participants satisfied with an after taste in DAQ

Timeframe: Day 1

Number of participants reported medicine run down throat in IAQ and DAQ

Timeframe: Day 1

Number of participants reported medicine run out of nose in IAQ and DAQ

Timeframe: Day 1

Number of participants reported product feel soothing in IAQ and DAQ

Timeframe: Day 1

Number of participants reported product make want to sneeze in IAQ

Timeframe: Day 1

Number of participants satisfied with product in DAQ

Timeframe: Day 1

Number of participants reported nasal irritation in DAQ

Timeframe: Day 1

Number of participants reported nasal irritation bothersome in DAQ

Timeframe: Day 1

Number of participants comply with product if prescribed in DAQ

Timeframe: Day 1

Interventions:
  • Drug: fluticasone propionate (FP)
  • Drug: fluticasone furoate (FF)
    • Enrollment:
    127
    Primary completion date:
    2006-04-12
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    E. O. Meltzer, J. Stahlman,J. Leflein,S. Meltzer, J. Lim, A.A. Dalal, B.A. Prillaman, E. Philpot. Preferences of Patients with Allergic Rhinitis for the Sensory Attributes of Fluticasone Furoate versus Fluticasone Propionate Nasal Sprays . Clinical Therapeutics. 2008;30 (2):271-279.
    Medical condition
    Rhinitis, Allergic, Perennial
    Product
    fluticasone furoate
    Collaborators
    Not applicable
    Study date(s)
    December 2006 to December 2006
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • allergic rhinitis
    • literate
    • clinical significant uncontrolled disease
    • Use of intranasal corticosteroids (<4 weeks of FP [branded or generic],<4 week exposure to FF, <4 weeks use of other INS)
    Inclusion and exclusion criteria
    Inclusion criteria:
    • allergic rhinitis
    • literate
    Exclusion criteria:
    • clinical significant uncontrolled disease
    • Use of intranasal corticosteroids (<4 weeks of FP [branded or generic],<4 week exposure to FF, <4 weeks use of other INS)
    • Use of intranasal medications <1 week
    • Use of meds that significantly inhibit CYP4503A4
    • Use of perfume or oral rinse on study day
    • Allergy/intolerance to INS, antihistamines, or excipients
    • Positive pregnancy test or female who is breastfeeding
    • Affiliation with investigational site

    Trial location(s)

    Location
    Status
    Contact us
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    Location
    GSK Investigational Site
    St. Louis, Missouri, United States, 63141
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Minneapolis, Minnesota, United States, 55402
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Rolla, Missouri, United States, 65401
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Ypsilanti, Michigan, United States, 48197
    Status
    Study Complete
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    Location
    GSK Investigational Site
    El Paso, Texas, United States, 79925
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Brick, New Jersey, United States, 8724
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 14 Results

    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

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2006-04-12
    Actual study completion date
    2006-04-12

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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