Single Dose Crossover Study of Patient Preference for Unscented Nasonex® Nasal Spray Versus Scented Flonase® Nasal Spray (Study P04207)(COMPLETED) - Full Text View

Purpose

This was a one-day single dose trial conducted to compare patient's preference for Nasonex® (mometasone) versus Flonase® nasal spray. Each patient was randomized to take one dose (2 sprays in each nostril) of Nasonex or Flonase. Thirty minutes later, each patient was to take one dose of the opposite medication. Questionnaires were given to each patient after each drug dose to evaluate patient product preference.

Condition	Intervention	Phase
Allergic Rhinitis	Drug: Mometasone Furoate Nasal Spray Drug: fluticasone nasal spray	Phase 4

Schering-Plough has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Preference Evaluation of Nasonex® Nasal Spray (Unscented) vs. Flonase® Nasal Spray (Scented) in Subjects With Symptomatic Allergic Rhinitis (AR) - Single-Dose Cross-Over

Resource links provided by NLM:

Drug Information available for: Fluticasone propionate Mometasone furoate Fluticasone Mometasone furoate monohydrate

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Overall product preference based on subjects' answer to the question "which product do you prefer overall" [ Time Frame: On the study day, after dose of each product ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Subject rating for likely compliance with daily dosing, [ Time Frame: On the study day, after dose of each product ] [ Designated as safety issue: No ]
Subject preference for glass or plastic bottle [ Time Frame: On the study day, after dose of each product ] [ Designated as safety issue: No ]
Subject response to if they would want a prescription for their preferred product and if they would recommend the product [ Time Frame: On the study day, after dose of each product ] [ Designated as safety issue: No ]
Subject response to whether they preferred inhaled corticosteroid with or without aftertaste, and/or scent/odor, [ Time Frame: On the study day, after dose of each product ] [ Designated as safety issue: No ]
Subject ratings for individual product attributes [ Time Frame: On the study day, after dose of each product ] [ Designated as safety issue: No ]

Enrollment:	100
Study Start Date:	December 2004
Study Completion Date:	January 2005
Primary Completion Date:	January 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Nasonex Followed by Flonase	Drug: Mometasone Furoate Nasal Spray One dose (2 sprays in each nostril) of Mometasone Furoate Nasal Spray Other Name: Nasonex, SCH 032088 Drug: fluticasone nasal spray One dose (2 sprays in each nostril) of fluticasone nasal spray Other Name: Flonase®
Active Comparator: Flonase Followed by Nasonex	Drug: Mometasone Furoate Nasal Spray One dose (2 sprays in each nostril) of Mometasone Furoate Nasal Spray Other Name: Nasonex, SCH 032088 Drug: fluticasone nasal spray One dose (2 sprays in each nostril) of fluticasone nasal spray Other Name: Flonase®

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject must have been 18-65 years of age, of either sex and any race.
Subject must have had symptomatic allergic rhinitis with a total nasal symptom (congestion, rhinorrhea, sneezing, itching) severity score of <6 but >2; congestion must have been <2.
Subject must have been free of any clinically significant disease (other than allergic rhinitis) that would interfere with study evaluations.
Subject must have understood and been able to adhere to the dosing and visit schedule.

Exclusion Criteria:

Subject had used any investigational product within 30 days prior to enrollment.
Subject was in a situation or condition that, in the opinion of the investigator, may have interfered with optimal participation in the study.
Subject was participating in any other clinical study(ies).
Subject was using any nasal lavage fluid or spray.
Subject was using any perfume during the study day.
Subject was using any oral rinse during the study day.
Subject had used topical or oral nasal decongestants in the past 1 week.
Subject had used a nasal corticosteroid in the previous 2 weeks.
Subject had anosmia or ageusia (absence of the sense of smell or taste).
Subject had been using medications which are associated with anosmia or ageusia in the 2 weeks prior to testing.
Subject had a respiratory infection in the 2 weeks prior to testing.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00817050 History of Changes
Other Study ID Numbers:	P04207
Study First Received:	January 5, 2009
Last Updated:	January 5, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Mometasone furoate
Fluticasone
Anti-Allergic Agents
Therapeutic Uses

Pharmacologic Actions
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on May 16, 2013