Fluticasone Nasal Spray Patient Preference Study

Rhinitis, Allergic, Perennial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00398476
• Other study ID #: FFU108556
• Status: Completed
• Phase: Phase 3
• First received: November 9, 2006
• Last updated: January 31, 2018
• Start date: December 1, 2006
• Est. completion date: December 4, 2006

Study information

• Verified date: June 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: December 4, 2006
• Est. primary completion date: December 4, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Perennial

Intervention

Drug:
• fluticasone propionate (FP)
200 micrograms (mcg); an aqueous suspension of microfine FP
• fluticasone furoate (FF)
110 mcg; an aqueous suspension containing 0.05% w/w of micronized FF

Locations

Country	Name	City	State
United States	GSK Investigational Site	Brick	New Jersey
United States	GSK Investigational Site	Denver	Colorado
United States	GSK Investigational Site	El Paso	Texas
United States	GSK Investigational Site	Fountain Valley	California
United States	GSK Investigational Site	Lakewood	Colorado
United States	GSK Investigational Site	Lawrenceville	Georgia
United States	GSK Investigational Site	Long Beach	California
United States	GSK Investigational Site	Minneapolis	Minnesota
United States	GSK Investigational Site	Rolla	Missouri
United States	GSK Investigational Site	Saint Louis	Missouri
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	Savannah	Georgia
United States	GSK Investigational Site	Skillman	New Jersey
United States	GSK Investigational Site	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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