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Fluticasone Nasal Spray Patient Preference Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00398476
First received: November 9, 2006
Last updated: May 27, 2017
Last verified: May 2017
  Purpose
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.

Condition Intervention Phase
Rhinitis, Allergic, Perennial Drug: fluticasone propionate (FP) Drug: fluticasone furoate (FF) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
Official Title: A Patient Preference Evaluation Study of Fluticasone Furoate Nasal Spray and Fluticasone Propionate Aqueous Nasal Spray in Subject With Allergic Rhinitis

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Overall Participants preference for nasal spray based on selected product attributes at the end of crossover dosing [ Time Frame: Day 1 ]
    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 [ Time Frame: Day 1 ]
    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 and DAQ [ Time Frame: Day 1 ]
    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 and DAQ [ Time Frame: Day 1 ]
    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 [ Time Frame: Day 1 ]
    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 [ Time Frame: Day 1 ]
    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 [ Time Frame: Day 1 ]
    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 [ Time Frame: Day 1 ]
    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 [ Time Frame: Day 1 ]
    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 [ Time Frame: Day 1 ]
    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 [ Time Frame: Day 1 ]
    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 [ Time Frame: Day 1 ]
    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 reported nasal irritation in DAQ [ Time Frame: Day 1 ]
    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 [ Time Frame: Day 1 ]
    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 satisfied with product in DAQ [ Time Frame: Day 1 ]
    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 comply with product if prescribed in DAQ [ Time Frame: Day 1 ]
    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.


Enrollment: 127
Actual Study Start Date: December 1, 2006
Study Completion Date: December 4, 2006
Primary Completion Date: December 4, 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: fluticasone propionate (FP)
200 micrograms (mcg); an aqueous suspension of microfine FP
Drug: fluticasone propionate (FP)
200 micrograms (mcg); an aqueous suspension of microfine FP
Active Comparator: fluticasone furoate (FF)
110 mcg; an aqueous suspension containing 0.05% w/w of micronized FF
Drug: fluticasone furoate (FF)
110 mcg; an aqueous suspension containing 0.05% w/w of micronized FF
Other Names:
  • fluticasone furoate
  • fluticasone propionate

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00398476

Locations
United States, California
GSK Investigational Site
Fountain Valley, California, United States, 92708
GSK Investigational Site
Long Beach, California, United States, 90808
GSK Investigational Site
San Diego, California, United States, 92123
United States, Colorado
GSK Investigational Site
Denver, Colorado, United States, 80230
GSK Investigational Site
Lakewood, Colorado, United States, 80401
United States, Georgia
GSK Investigational Site
Lawrenceville, Georgia, United States, 30045
GSK Investigational Site
Savannah, Georgia, United States, 31406
United States, Michigan
GSK Investigational Site
Ypsilanti, Michigan, United States, 48197
United States, Minnesota
GSK Investigational Site
Minneapolis, Minnesota, United States, 55402
United States, Missouri
GSK Investigational Site
Rolla, Missouri, United States, 65401
GSK Investigational Site
Saint Louis, Missouri, United States, 63141
United States, New Jersey
GSK Investigational Site
Bricktown, New Jersey, United States, 8724
GSK Investigational Site
Skillman, New Jersey, United States, 08558
United States, Texas
GSK Investigational Site
El Paso, Texas, United States, 79925
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00398476     History of Changes
Other Study ID Numbers: FFU108556
Study First Received: November 9, 2006
Last Updated: May 27, 2017

Keywords provided by GlaxoSmithKline:
taste
questionnaire
preference
attributes
odor
after taste
scent

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on June 23, 2017