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Fluticasone Nasal Spray Patient Preference Study

NCT ID: NCT00398476

Last Updated: 2018-03-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-01

Study Completion Date

2006-12-04

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.

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Detailed Description

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Conditions

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Rhinitis, Allergic, Perennial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Study Groups

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fluticasone propionate (FP)

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

Group Type ACTIVE_COMPARATOR

fluticasone propionate (FP)

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

fluticasone furoate (FF)

Intervention Type DRUG

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

Interventions

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fluticasone propionate (FP)

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

Intervention Type DRUG

fluticasone furoate (FF)

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

Intervention Type DRUG

Other Intervention Names

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fluticasone furoate fluticasone propionate

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Fountain Valley, California, United States

Site Status

GSK Investigational Site

Long Beach, California, United States

Site Status

GSK Investigational Site

San Diego, California, United States

Site Status

GSK Investigational Site

Denver, Colorado, United States

Site Status

GSK Investigational Site

Lakewood, Colorado, United States

Site Status

GSK Investigational Site

Lawrenceville, Georgia, United States

Site Status

GSK Investigational Site

Savannah, Georgia, United States

Site Status

GSK Investigational Site

Ypsilanti, Michigan, United States

Site Status

GSK Investigational Site

Minneapolis, Minnesota, United States

Site Status

GSK Investigational Site

Rolla, Missouri, United States

Site Status

GSK Investigational Site

St Louis, Missouri, United States

Site Status

GSK Investigational Site

Brick, New Jersey, United States

Site Status

GSK Investigational Site

Skillman, New Jersey, United States

Site Status

GSK Investigational Site

El Paso, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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FFU108556

Identifier Type: -

Identifier Source: org_study_id

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