Study of Nasonex in the Relief of Nasal Congestion in Patients With Seasonal Allergic Rhinitis (Study P05529)

Last updated: May 8, 2024
Sponsor: Organon and Co
Overall Status: Completed

Phase

3

Condition

Allergies & Asthma

Nasal Obstruction

Common Cold

Treatment

Mometasone furoate nasal spray (MFNS)

Matching placebo nasal spray

Clinical Study ID

NCT00732381
P05529
  • Ages > 12
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 thestudy season.

  • A subject must have a positive skin prick test response to an appropriate seasonalallergen at Visit 1.

  • A subject must be clinically symptomatic at the Screening and Baseline Visits.

Exclusion

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 requiredantibiotic 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 theScreening Visit.

  • A subject who has used any drug in an investigational protocol in the 30 days priorto 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 investigationalstudy 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 inthis study.

Study Design

Total Participants: 351
Treatment Group(s): 2
Primary Treatment: Mometasone furoate nasal spray (MFNS)
Phase: 3
Study Start date:
August 01, 2008
Estimated Completion Date:
November 30, 2008