Fluticasone Nasal Spray Patient Preference Study

Study Overview
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Brief Summary
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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.

Official Title
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A Patient Preference Evaluation Study of Fluticasone Furoate Nasal Spray and Fluticasone Propionate Aqueous Nasal Spray in Subject With Allergic Rhinitis

Conditions
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Rhinitis, Allergic, Perennial

Intervention / Treatment
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* Drug: fluticasone propionate (FP)
* Drug: fluticasone furoate (FF)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: fluticasone propionate (FP)<br>200 micrograms (mcg); an aqueous suspension of microfine FP | Drug: fluticasone propionate (FP)<br>* 200 micrograms (mcg); an aqueous suspension of microfine FP<br>|
| Active Comparator: fluticasone furoate (FF)<br>110 mcg; an aqueous suspension containing 0.05% w/w of micronized FF | Drug: fluticasone furoate (FF)<br>* 110 mcg; an aqueous suspension containing 0.05% w/w of micronized FF<br>* Other names: fluticasone propionate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 1 | 
| 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. | Day 1 | 
| 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. | Day 1 | 
| 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. | Day 1 | 
| 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. | Day 1 | 
| 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. | Day 1 | 
| 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. | Day 1 | 
| 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. | Day 1 | 
| 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. | Day 1 | 
| 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. | Day 1 | 
| 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. | Day 1 | 
| 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. | Day 1 | 
| 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. | Day 1 | 
| 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. | Day 1 | 
| 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. | Day 1 | 
| 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. | Day 1 | 
| 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. | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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taste, questionnaire, preference, attributes, odor, after taste, scent