Last updated: 11/07/2018 16:52:04
Fluticasone Nasal Spray Patient Preference Study
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2006-04-12
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
GSK Investigational Site
St. Louis, Missouri, United States, 63141
Status
Study Complete
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55402
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Rolla, Missouri, United States, 65401
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Ypsilanti, Michigan, United States, 48197
Status
Study Complete
Location
GSK Investigational Site
Brick, New Jersey, United States, 8724
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92123
Status
Study Complete
Location
GSK Investigational Site
Denver, Colorado, United States, 80230
Status
Study Complete
Location
GSK Investigational Site
Fountain Valley, California, United States, 92708
Status
Study Complete
Location
GSK Investigational Site
Skillman, New Jersey, United States, 08558
Status
Study Complete
Location
GSK Investigational Site
Lawrenceville, Georgia, United States, 30045
Status
Study Complete
Location
GSK Investigational Site
Savannah, Georgia, United States, 31406
Status
Study Complete
Location
GSK Investigational Site
Long Beach, California, United States, 90808
Status
Study Complete
Location
GSK Investigational Site
Lakewood, Colorado, United States, 80401
Status
Study Complete
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
Results posted on ClinicalTrials.gov
Recruitment status
Completed
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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