Single Dose Crossover Study of Patient Preference for Unscented Nasonex® Nasal Spray Versus Scented Flonase® Nasal Spray (Study P04208)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00783458
First received: October 30, 2008
Last updated: July 3, 2014
Last verified: July 2014
  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

Merck Sharp & Dohme Corp. 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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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 ratings for individual product attributes [ Time Frame: On the study day, after dose of each product ] [ Designated as safety issue: No ]
  • 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 ]

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
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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00783458     History of Changes
Other Study ID Numbers: P04208
Study First Received: October 30, 2008
Last Updated: July 3, 2014
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 July 28, 2014