NCT00491504

This Study Contains an Active Drug Treatment Group With Mometasone Furoate Nasal Spray and a Placebo (Dummy) Treatment Group for Seasonal Allergic Rhinitis (SAR). (Study P05073)(COMPLETED)

A Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Study Using Subjective and Objective Measures to Evaluate the Clinical Efficacy of Mometasone Furoate Nasal Spray (MFNS) Following Initial and Maintenance Dosing in Subjects With Allergen-Induced Seasonal Allergic Rhinitis (SAR) in an Environmental Exposure Chamber (EEC)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 310 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate how well mometasone furoate nasal spray (MFNS) works to relieve SAR symptoms compared to Placebo when symptoms are induced in a chamber setting. Evaluation will be based on subjects self-assessed nose symptoms. Other areas the study will evaluate are: 1) changes in eye symptoms (ocular symptom severity score) after dosing 2) how long MFNS works in relieving the nose (nasal) and eye (ocular) symptoms after 7 daily doses, 3) measurements of nose (nasal) blockage (obstruction), and 4) measurements of the subject's opinion of the study drugs by asking different questions. This study is could last up to 53 days for some subjects.

Conditions

• Seasonal Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Mometasone Furoate Nasal Spray	Mometasone Furoate Nasal Spray: 2 sprays (50 mcg) each nostril (total 200 mcg)
OTHER	Placebo	Placebo: 2 sprays in each nostril

Timeline

• Start date: 2007-02-01
• Primary completion: 2007-07-01
• Completion: 2007-07-01
• First posted: 2007-06-26
• Last updated: 2022-02-09
• Results posted: 2010-04-05