Fluticasone Nasal Spray Patient Preference Study
A Patient Preference Evaluation Study of Fluticasone Furoate Nasal Spray and Fluticasone Propionate Aqueous Nasal Spray in Subject With Allergic Rhinitis
1 other identifier
interventional
127
1 country
14
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2006
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2006
CompletedFirst Posted
Study publicly available on registry
November 10, 2006
CompletedStudy Start
First participant enrolled
December 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 4, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 4, 2006
CompletedResults Posted
Study results publicly available
January 29, 2018
CompletedMarch 1, 2018
June 1, 2017
3 days
November 9, 2006
June 8, 2017
January 31, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing
An overall preference questionnaire (OPQ) was used to evaluate participant's preference for nasal spray therapy for the given treatments. OPQ allows the responder three options, based on products attributes, i.e. preference for product 1 (FF 110 µg); preference for product 2 (FP 200 µg) and no preference. Three participant-related questionnaires were completed during the course of the study, including two attributes questionnaires : Immediate attributes questionnaire (IAQ) and delayed attributes questionnaire (DAQ). An OPQ was completed upon completion of the crossover dosing.
Day 1
Secondary Outcomes (17)
Number of Participants With Preference for Scent/Odor in IAQ and DAQ
Day 1
Number of Participants With Preference for Satisfaction With Scent/Odor in IAQ
Day 1
Number of Participants With Preference for Satisfaction With Scent/Odor in DAQ
Day 1
Number of Participants Who Satisfied Not to Have Scent/Odor in IAQ
Day 1
Number of Participants Who Satisfied Not to Have Scent/Odor in DAQ
Day 1
- +12 more secondary outcomes
Study Arms (2)
fluticasone propionate (FP)
ACTIVE COMPARATOR200 micrograms (mcg); an aqueous suspension of microfine FP
fluticasone furoate (FF)
ACTIVE COMPARATOR110 mcg; an aqueous suspension containing 0.05% w/w of micronized FF
Interventions
200 micrograms (mcg); an aqueous suspension of microfine FP
110 mcg; an aqueous suspension containing 0.05% w/w of micronized FF
Eligibility Criteria
You may qualify if:
- allergic rhinitis
- literate
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (14)
GSK Investigational Site
Fountain Valley, California, 92708, United States
GSK Investigational Site
Long Beach, California, 90808, United States
GSK Investigational Site
San Diego, California, 92123, United States
GSK Investigational Site
Denver, Colorado, 80230, United States
GSK Investigational Site
Lakewood, Colorado, 80401, United States
GSK Investigational Site
Lawrenceville, Georgia, 30045, United States
GSK Investigational Site
Savannah, Georgia, 31406, United States
GSK Investigational Site
Ypsilanti, Michigan, 48197, United States
GSK Investigational Site
Minneapolis, Minnesota, 55402, United States
GSK Investigational Site
Rolla, Missouri, 65401, United States
GSK Investigational Site
St Louis, Missouri, 63141, United States
GSK Investigational Site
Brick, New Jersey, 8724, United States
GSK Investigational Site
Skillman, New Jersey, 08558, United States
GSK Investigational Site
El Paso, Texas, 79925, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2006
First Posted
November 10, 2006
Study Start
December 1, 2006
Primary Completion
December 4, 2006
Study Completion
December 4, 2006
Last Updated
March 1, 2018
Results First Posted
January 29, 2018
Record last verified: 2017-06