Study of Nasonex in the Relief of Nasal Congestion in Patients With Seasonal Allergic Rhinitis (Study P05528)(COMPLETED)

Overview

This study seeks to prospectively demonstrate that Nasonex is better than placebo in relieving nasal congestion in patients with seasonal allergic rhinitis.

Full Title of Study: “Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg QD in the Relief of Nasal Congestion Associated With Seasonal Allergic Rhinitis (SAR)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 2008

Interventions

  • Drug: Mometasone furoate nasal spray (MFNS)
    • MFNS 50 mcg/spray: two sprays in each nostril once daily (ie, 200 mcg QD) for 15 days
  • Drug: Matching placebo nasal spray
    • Matching placebo nasal spray: 2 sprays in each nostril once daily for 15 days

Arms, Groups and Cohorts

  • Experimental: Arm 1
    • Mometasone furoate nasal spray 200 mcg QD (once per day)
  • Placebo Comparator: Arm 2
    • Matching placebo nasal spray

Clinical Trial Outcome Measures

Primary Measures

  • The Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days.
    • Time Frame: 15 days of treatment
    • Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. PRIOR (the subject’s status over the previous 12 hours [reflective])

Secondary Measures

  • The Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days
    • Time Frame: 15 days of treatment
    • Total nasal symptom score (TNSS) is a composite of 4 symptoms, each is scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total can range from 0 to 12.

Participating in This Clinical Trial

Inclusion Criteria

  • A subject must be 12 years of age or older, of either sex, and of any race. – A subject must have at least a 2-year history of SAR which exacerbates during the study season. – A subject must have a positive skin prick test response to an appropriate seasonal allergen at Visit 1. – A subject must be clinically symptomatic at the Screening and Baseline Visits. Exclusion Criteria:

  • A subject with a history of severe local reaction(s) or anaphylaxis to skin testing. – A subject who has had an upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or who has had a viral upper respiratory infection within 7 days prior to the Screening Visit. – A subject who has used any drug in an investigational protocol in the 30 days prior to the Screening Visit. – A subject who is participating in any other clinical study. – A subject who is part of the staff personnel directly involved with this study. – A subject who is a family member (parent, spouse, or sibling) of the investigational study staff. – A female subject who is breast-feeding, pregnant, or intends to become pregnant. – A subject previously randomized into this study. – A subject who has a family member (parent, spouse, or sibling) currently enrolled in this study.

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Organon and Co
  • Provider of Information About this Clinical Study
    • Sponsor

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