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

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

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

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis
• Intervention / Treatment: Drug: Mometasone furoate nasal spray (MFNS); Drug: Matching placebo nasal spray

• Study Type: Interventional
• Enrollment (Actual): 351
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm 1; Mometasone furoate nasal spray 200 mcg QD (once per day)	Drug: Mometasone furoate nasal spray (MFNS); MFNS 50 mcg/spray: two sprays in each nostril once daily (ie, 200 mcg QD) for 15 days; Other Names: Nasonex Nasal Spray
PLACEBO_COMPARATOR: Arm 2; Matching placebo nasal spray	Drug: Matching placebo nasal spray; Matching placebo nasal spray: 2 sprays in each nostril once daily for 15 days; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days	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. PRIOR (the subject's status over the previous 12 hours [reflective])	15 days of treatment

Collaborators and Investigators

• Sponsor: Organon and Co

Publications and helpful links

General Publications

• Meltzer EO, Shekar T, Teper AA. Mometasone furoate nasal spray for moderate-to-severe nasal congestion in subjects with seasonal allergic rhinitis. Allergy Asthma Proc. 2011 Mar-Apr;32(2):159-67. doi: 10.2500/aap.2011.32.3424.

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (ACTUAL): November 1, 2008
• Study Completion (ACTUAL): November 1, 2008

Study Registration Dates

• First Submitted: August 8, 2008
• First Submitted That Met QC Criteria: August 8, 2008
• First Posted (ESTIMATE): August 12, 2008

Study Record Updates

• Last Update Posted (ACTUAL): February 16, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Anti-Inflammatory Agents; Dermatologic Agents; Anti-Allergic Agents; Mometasone Furoate
• Other Study ID Numbers: P05529

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php