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

Phase 3

Completed

• Conditions: Allergic Rhinitis
• Interventions: Drug: Mometasone furoate nasal spray (MFNS); Drug: Matching placebo nasal spray

• Registration Number: NCT00733005
• Lead Sponsor: Organon and Co

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-08-08
• Study First Submitted QC: 2008-08-08
• Study First Posted: 2008-08-12
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Results First Submitted: 2009-10-13
• Results First Submitted QC: 2009-10-13
• Results First Posted: 2009-11-19
• Status Verified: 2022-02
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 324

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Mometasone furoate nasal spray (MFNS)	Mometasone furoate nasal spray 200 mcg QD (once per day)
Arm 2	Matching placebo nasal spray	Matching placebo nasal spray

Primary Outcome Measures

Name	Time	Method
The Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days.	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 Outcome Measures

Name	Time	Method
The Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days	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.