Clinical trial NCT00398476: Fluticasone Nasal Spray Patient Preference Study
Official title: A Patient Preference Evaluation Study of Fluticasone Furoate Nasal Spray and Fluticasone Propionate Aqueous Nasal Spray in Subject With Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinitis, Allergic, Perennial
Keywords: taste
questionnaire
preference
attributes
odor
after taste
scent
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-11-10
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing
timeFrame: Day 1
Secondary outcomes:
measure: Number of Participants With Preference for Scent/Odor in IAQ and DAQ
timeFrame: Day 1
measure: Number of Participants With Preference for Satisfaction With Scent/Odor in IAQ
timeFrame: Day 1
measure: Number of Participants With Preference for Satisfaction With Scent/Odor in DAQ
timeFrame: Day 1
measure: Number of Participants Who Satisfied Not to Have Scent/Odor in IAQ
timeFrame: Day 1
measure: Number of Participants Who Satisfied Not to Have Scent/Odor in DAQ
timeFrame: Day 1
measure: Number of Participants Reported Product Have an Immediate Taste in IAQ
timeFrame: Day 1
measure: Number of Participants Satisfied With an Immediate Taste in IAQ
timeFrame: Day 1
measure: Number of Participants Reported Product Have an After Taste in DAQ
timeFrame: Day 1
measure: Number of Participants Satisfied With an After Taste in DAQ
timeFrame: Day 1
measure: Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ
timeFrame: Day 1
measure: Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ
timeFrame: Day 1
measure: Number of Participants Reported Product Feel Soothing in IAQ and DAQ
timeFrame: Day 1
measure: Number of Participants Reported Product Make Want to Sneeze in IAQ
timeFrame: Day 1
measure: Number of Participants Satisfied With Product in DAQ
timeFrame: Day 1
measure: Number of Participants Reported Nasal Irritation in DAQ
timeFrame: Day 1
measure: Number of Participants Reported Nasal Irritation Bothersome in DAQ
timeFrame: Day 1
measure: Number of Participants Comply With Product if Prescribed in DAQ
timeFrame: Day 1
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: GSK Investigational Site
state: California
city: Long Beach
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: Denver
country: United States
facility: GSK Investigational Site
state: Colorado
city: Lakewood
country: United States
facility: GSK Investigational Site
state: Colorado
city: Lawrenceville
country: United States
facility: GSK Investigational Site
state: Georgia
city: Savannah
country: United States
facility: GSK Investigational Site
state: Georgia
city: Ypsilanti
country: United States
facility: GSK Investigational Site
state: Michigan
city: Minneapolis
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Rolla
country: United States
facility: GSK Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: GSK Investigational Site
state: Missouri
city: Brick
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Skillman
country: United States
facility: GSK Investigational Site
state: New Jersey
city: El Paso
country: United States
facility: GSK Investigational Site
state: Texas
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: