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

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

Completed

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Key information

Conditions

Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mometasone Furoate Nasal Spray (MFNS)

Drug

MFNS 50 mcg/spray: two sprays in each nostril once daily (ie, 200 mcg QD) for 15 days

Other names: Nasonex Nasal Spray

Matching placebo nasal spray

Drug

Matching placebo nasal spray: 2 sprays in each nostril once daily for 15 days

Other names: Placebo

Primary outcomes

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2008
Study completion: 2008
First posted: Aug 12, 2008
Registry last updated: May 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed