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Fluticasone Nasal Spray Patient Preference Study

Primary Purpose

Rhinitis, Allergic, Perennial

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
fluticasone propionate (FP)
fluticasone furoate (FF)
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhinitis, Allergic, Perennial focused on measuring taste, questionnaire, preference, attributes, odor, after taste, scent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

fluticasone propionate (FP)

fluticasone furoate (FF)

Arm Description

200 micrograms (mcg); an aqueous suspension of microfine FP

110 mcg; an aqueous suspension containing 0.05% w/w of micronized FF

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Participants With Preference for Scent/Odor in IAQ and DAQ
Participant preference for scent/odor at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ and DAQ having question: Did product have a scent/odor?. Participants specified their responses on a 6-point scale: 0: none; 1: very mild; 2: mild; 3: neither mild nor strong; 4: slightly strong; 5; moderately strong; 6: very strong. Higher score indicated strong odor.
Number of Participants With Preference for Satisfaction With Scent/Odor in IAQ
Participant preference for Satisfaction scent/odor at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ having question: How satisfied with scent/odor?. Participants specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied.
Number of Participants With Preference for Satisfaction With Scent/Odor in DAQ
Participant preference for Satisfaction scent/odor at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ and DAQ having question: How satisfied with scent/odor?. Participants specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied.
Number of Participants Who Satisfied Not to Have Scent/Odor in IAQ
Participant preference for participants who satisfied not to have scent/odor at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ having question: How satisfied not to have scent/odor?. Participants specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied.
Number of Participants Who Satisfied Not to Have Scent/Odor in DAQ
Participant preference for participants who satisfied not to have scent/odor at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ and DAQ having question: How satisfied not to have scent/odor?. Participants specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied.
Number of Participants Reported Product Have an Immediate Taste in IAQ
Participant preference for an immediate taste at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ having question: Did product have an immediate taste?. Participants specified their responses on a on a 6-point scale: 0: no; 1: very mild; 2: mild; 3: neither mild nor strong; 4: slightly strong; 5; moderately strong; 6: very strong.
Number of Participants Satisfied With an Immediate Taste in IAQ
Participant preference for satisfaction with an immediate taste at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ having question: How satisfied with immediate taste?. Participants specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied.
Number of Participants Reported Product Have an After Taste in DAQ
Participant response for an after taste at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using DAQ having question: Did product have an aftertaste?. Participants specified their responses on a 6-point scale: 0: No aftertaste; 1: Very mild; 2: Mild; 3: Neither mild nor strong; 4: Slightly strong; 5: Moderately strong; 6: Very strong.
Number of Participants Satisfied With an After Taste in DAQ
Participant response for satisfaction with an after taste at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using DAQ having question: How satisfied with aftertaste? Participants specified their responses on a 6-point scale: 0: Very satisfied; 1: Moderately satisfied; 2: Somewhat satisfied; 3: Neither satisfied nor dissatisfied; 4: Somewhat dissatisfied; 5: Moderately dissatisfied; 6: Very dissatisfied.
Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ
Participant response regarding did the medicine run down throat at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ and DAQ having question: Did medicine run down throat? Participants specified their responses on a 6-point scale: 0: None; 1: Very slightly; 2: Slightly; 3: Neither slightly nor moderately; 4: Moderately; 5: Markedly; 6: Very markedly.
Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ
Participant response regarding did the medicine run out of nose at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ and DAQ having question: Did medicine run out of nose? Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly.
Number of Participants Reported Product Feel Soothing in IAQ and DAQ
Participant response for soothing feel at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ and DAQ having question: Did product feel soothing?. Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly.
Number of Participants Reported Product Make Want to Sneeze in IAQ
Participant response regarding sneezing effect at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ having question: Did product make want to sneeze?. Participants specified their responses on a 6-point scale: 0: No urgency; 1: Very slight urgency; 2: slight urgency; 3: Neither slight nor moderate urgency; 4: Moderate urgency; 5; Marked urgency; 6: Very marked urgency.
Number of Participants Satisfied With Product in DAQ
Number of participants responding to product satisfaction with delayed attributes questionnaire, Question: How satisfied with product?. Participants specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied.
Number of Participants Reported Nasal Irritation in DAQ
Participant response regarding nasal irritation at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using DAQ having question: Did product cause nasal irritation?. Participants specified their responses on a 6-point scale: 0: none; 1: very slight; 2: slight; 3: neither slight nor moderate; 4: moderate; 5; marked; 6: very marked.
Number of Participants Reported Nasal Irritation Bothersome in DAQ
Participant response regarding bothersome of nasal irritation at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using DAQ having question: How bothersome was nasal irritation?. Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly.
Number of Participants Comply With Product if Prescribed in DAQ
Number of participants responding to product attributes using delayed attributes questionnaire, Question: How likely to comply if prescribed?. Participants specified their responses on a 6-point scale: 0: very likely; 1: moderately likely; 2: somewhat likely; 3: neither likely nor unlikely; 4: somewhat unlikely; 5; moderately unlikely; 6: very unlikely.

Full Information

First Posted
November 9, 2006
Last Updated
January 31, 2018
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00398476
Brief Title
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

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
December 1, 2006 (Actual)
Primary Completion Date
December 4, 2006 (Actual)
Study Completion Date
December 4, 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis, Allergic, Perennial
Keywords
taste, questionnaire, preference, attributes, odor, after taste, scent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Allocation
Randomized
Enrollment
127 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fluticasone propionate (FP)
Arm Type
Active Comparator
Arm Description
200 micrograms (mcg); an aqueous suspension of microfine FP
Arm Title
fluticasone furoate (FF)
Arm Type
Active Comparator
Arm Description
110 mcg; an aqueous suspension containing 0.05% w/w of micronized FF
Intervention Type
Drug
Intervention Name(s)
fluticasone propionate (FP)
Intervention Description
200 micrograms (mcg); an aqueous suspension of microfine FP
Intervention Type
Drug
Intervention Name(s)
fluticasone furoate (FF)
Other Intervention Name(s)
fluticasone furoate, fluticasone propionate
Intervention Description
110 mcg; an aqueous suspension containing 0.05% w/w of micronized FF
Primary Outcome Measure Information:
Title
Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing
Description
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.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Number of Participants With Preference for Scent/Odor in IAQ and DAQ
Description
Participant preference for scent/odor at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ and DAQ having question: Did product have a scent/odor?. Participants specified their responses on a 6-point scale: 0: none; 1: very mild; 2: mild; 3: neither mild nor strong; 4: slightly strong; 5; moderately strong; 6: very strong. Higher score indicated strong odor.
Time Frame
Day 1
Title
Number of Participants With Preference for Satisfaction With Scent/Odor in IAQ
Description
Participant preference for Satisfaction scent/odor at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ having question: How satisfied with scent/odor?. Participants specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied.
Time Frame
Day 1
Title
Number of Participants With Preference for Satisfaction With Scent/Odor in DAQ
Description
Participant preference for Satisfaction scent/odor at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ and DAQ having question: How satisfied with scent/odor?. Participants specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied.
Time Frame
Day 1
Title
Number of Participants Who Satisfied Not to Have Scent/Odor in IAQ
Description
Participant preference for participants who satisfied not to have scent/odor at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ having question: How satisfied not to have scent/odor?. Participants specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied.
Time Frame
Day 1
Title
Number of Participants Who Satisfied Not to Have Scent/Odor in DAQ
Description
Participant preference for participants who satisfied not to have scent/odor at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ and DAQ having question: How satisfied not to have scent/odor?. Participants specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied.
Time Frame
Day 1
Title
Number of Participants Reported Product Have an Immediate Taste in IAQ
Description
Participant preference for an immediate taste at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ having question: Did product have an immediate taste?. Participants specified their responses on a on a 6-point scale: 0: no; 1: very mild; 2: mild; 3: neither mild nor strong; 4: slightly strong; 5; moderately strong; 6: very strong.
Time Frame
Day 1
Title
Number of Participants Satisfied With an Immediate Taste in IAQ
Description
Participant preference for satisfaction with an immediate taste at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ having question: How satisfied with immediate taste?. Participants specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied.
Time Frame
Day 1
Title
Number of Participants Reported Product Have an After Taste in DAQ
Description
Participant response for an after taste at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using DAQ having question: Did product have an aftertaste?. Participants specified their responses on a 6-point scale: 0: No aftertaste; 1: Very mild; 2: Mild; 3: Neither mild nor strong; 4: Slightly strong; 5: Moderately strong; 6: Very strong.
Time Frame
Day 1
Title
Number of Participants Satisfied With an After Taste in DAQ
Description
Participant response for satisfaction with an after taste at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using DAQ having question: How satisfied with aftertaste? Participants specified their responses on a 6-point scale: 0: Very satisfied; 1: Moderately satisfied; 2: Somewhat satisfied; 3: Neither satisfied nor dissatisfied; 4: Somewhat dissatisfied; 5: Moderately dissatisfied; 6: Very dissatisfied.
Time Frame
Day 1
Title
Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ
Description
Participant response regarding did the medicine run down throat at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ and DAQ having question: Did medicine run down throat? Participants specified their responses on a 6-point scale: 0: None; 1: Very slightly; 2: Slightly; 3: Neither slightly nor moderately; 4: Moderately; 5: Markedly; 6: Very markedly.
Time Frame
Day 1
Title
Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ
Description
Participant response regarding did the medicine run out of nose at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ and DAQ having question: Did medicine run out of nose? Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly.
Time Frame
Day 1
Title
Number of Participants Reported Product Feel Soothing in IAQ and DAQ
Description
Participant response for soothing feel at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ and DAQ having question: Did product feel soothing?. Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly.
Time Frame
Day 1
Title
Number of Participants Reported Product Make Want to Sneeze in IAQ
Description
Participant response regarding sneezing effect at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ having question: Did product make want to sneeze?. Participants specified their responses on a 6-point scale: 0: No urgency; 1: Very slight urgency; 2: slight urgency; 3: Neither slight nor moderate urgency; 4: Moderate urgency; 5; Marked urgency; 6: Very marked urgency.
Time Frame
Day 1
Title
Number of Participants Satisfied With Product in DAQ
Description
Number of participants responding to product satisfaction with delayed attributes questionnaire, Question: How satisfied with product?. Participants specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied.
Time Frame
Day 1
Title
Number of Participants Reported Nasal Irritation in DAQ
Description
Participant response regarding nasal irritation at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using DAQ having question: Did product cause nasal irritation?. Participants specified their responses on a 6-point scale: 0: none; 1: very slight; 2: slight; 3: neither slight nor moderate; 4: moderate; 5; marked; 6: very marked.
Time Frame
Day 1
Title
Number of Participants Reported Nasal Irritation Bothersome in DAQ
Description
Participant response regarding bothersome of nasal irritation at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using DAQ having question: How bothersome was nasal irritation?. Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly.
Time Frame
Day 1
Title
Number of Participants Comply With Product if Prescribed in DAQ
Description
Number of participants responding to product attributes using delayed attributes questionnaire, Question: How likely to comply if prescribed?. Participants specified their responses on a 6-point scale: 0: very likely; 1: moderately likely; 2: somewhat likely; 3: neither likely nor unlikely; 4: somewhat unlikely; 5; moderately unlikely; 6: very unlikely.
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
GSK Investigational Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90808
Country
United States
Facility Name
GSK Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
GSK Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
GSK Investigational Site
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
GSK Investigational Site
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30045
Country
United States
Facility Name
GSK Investigational Site
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
GSK Investigational Site
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
GSK Investigational Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
GSK Investigational Site
City
Rolla
State/Province
Missouri
ZIP/Postal Code
65401
Country
United States
Facility Name
GSK Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
GSK Investigational Site
City
Brick
State/Province
New Jersey
ZIP/Postal Code
8724
Country
United States
Facility Name
GSK Investigational Site
City
Skillman
State/Province
New Jersey
ZIP/Postal Code
08558
Country
United States
Facility Name
GSK Investigational Site
City
El Paso
State/Province
Texas
ZIP/Postal Code
79925
Country
United States

12. IPD Sharing Statement

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Fluticasone Nasal Spray Patient Preference Study

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