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

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00817050
First received: January 5, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted

January 5, 2009
January 5, 2009
December 2004
January 2005   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Single Dose Crossover Study of Patient Preference for Unscented Nasonex® Nasal Spray Versus Scented Flonase® Nasal Spray (Study P04207)(COMPLETED)
A Preference Evaluation of Nasonex® Nasal Spray (Unscented) vs. Flonase® Nasal Spray (Scented) in Subjects With Symptomatic Allergic Rhinitis (AR) - Single-Dose Cross-Over

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Allergic Rhinitis
  • 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: Nasonex Followed by Flonase
    Interventions:
    • Drug: Mometasone Furoate Nasal Spray
    • Drug: fluticasone nasal spray
  • Active Comparator: Flonase Followed by Nasonex
    Interventions:
    • Drug: Mometasone Furoate Nasal Spray
    • Drug: fluticasone nasal spray
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
January 2005
January 2005   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00817050
P04207
No
Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Schering-Plough
Not Provided
Not Provided
Schering-Plough
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP