Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg QD in the Treatment of Seasonal Allergic Rhinitis

Organon and Co0 sites429 target enrollmentMarch 2007

ConditionsSeasonal Allergic Rhinitis

InterventionsMometasone furoate nasal spray Placebo

DrugsPlacebo Mometasone furoate nasal spray

Overview

Phase: Phase 3
Intervention: Mometasone furoate nasal spray
Conditions: Seasonal Allergic Rhinitis
Sponsor: Organon and Co
Enrollment: 429
Primary Endpoint: Change From Baseline in Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This study is designed to assess the effectiveness of mometasone furoate nasal spray (MFNS) once daily compared with placebo in subjects with seasonal allergic rhinitis (SAR) in reducing the total symptom score.

Registry

clinicaltrials.gov

Start Date

March 2007

End Date

July 2007

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Organon and Co

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Must be 12 years of age or older, of either sex and of any race.
•Must have at least a 2-year documented history of SAR which exacerbates during the study season.
•Must have a positive skin-prick test response to an appropriate seasonal allergen at Screening (Visit 1). IgE-mediated hypersensitivity to an appropriate seasonal allergen (ie, prevailing trees and/or grasses) must be documented by a positive response to the skin prick test with wheal diameter at least 3 mm larger than diluent control after 20 minutes.
•Must be clinically symptomatic at the Screening Visit.
•Must be clinically symptomatic at the Baseline Visit.
•Must be in general good health as confirmed by routine clinical and laboratory testing and ECG results. Clinical laboratory test (CBC, blood chemistries, and urinalysis) must be within normal limits or clinically acceptable to the investigator and the sponsor.
•Must be free of any clinically significant disease, other than SAR, that would interfere with the study evaluations.
•A subject and/or a parent/guardian must be willing to give written informed consent and must be able to adhere to dosing and visit schedules and meet study requirements.
•A female subject of childbearing potential must have a negative serum pregnancy test (HCG) at Screening. Nonsterile and premenopausal female subjects must be using a medically acceptable method of birth control, ie, double barrier method, oral contraceptive, hormonal implant, or depot injectable prior to Screening and during the study.

Exclusion Criteria

•A history of anaphylaxis and/or other severe local reaction(s) to skin testing.
•A subject with asthma who require chronic use of inhaled or systemic corticosteroids.
•Current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip.
•A subject with rhinitis medicamentosa.
•A history of allergies to more than two classes of medications or who are allergic to or cannot tolerate nasal sprays.
•A subject who have 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 have had a viral upper respiratory infection within 7 days before the Screening Visit.
•A subject who has nasal structural abnormalities, including large nasal polyps and marked septal deviations, which significantly interfere with nasal air flow.
•A subject who, in the opinion of the investigator, is dependent on nasal, oral, or ocular decongestants, nasal topical antihistamines, or nasal steroids.
•Use of any drug in an investigational protocol in the 30 days before the Screening Visit.
•A subject on immunotherapy (desensitization therapy), unless the subject is on a regular maintenance schedule prior to the Screening Visit and will stay on this schedule for the remainder of the study. A subject may not receive desensitization treatment within 24 hours before any visit.

Arms & Interventions

Mometasone Furoate Nasal Spray (MFNS)

200 mcg daily

Intervention: Mometasone furoate nasal spray

Placebo

Two sprays in each nostril in the morning

Intervention: Placebo

Outcomes

Primary Outcomes

Change From Baseline in Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15

Time Frame: Screening through 15 days daily

TNSS was defined as the sum of the following four nasal symptoms: rhinorrhea, nasal congestion/stuffiness, nasal itching, and sneezing; each symptom scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 12.

Change From Baseline in Average AM Instantaneous (NOW) Total Ocular Symptom Score (TOSS) Averaged Over Days 2 to 15

Time Frame: Screening through 15 days daily

TOSS was defined as the sum of the following three ocular symptoms: redness of eyes, itching/burning eyes, and tearing/watering eyes; each symptom scored on a scale of 0=none, 1=mild, 2=moderate, and 3=severe. The best possible score on this scale is 0 and the worst possible score on the scale is 9.

Secondary Outcomes

Change From Baseline in AM Peak Nasal Inspiratory Flow (PNIF) Averaged Over Days 2 to 15(Screening through 15 days daily)
Change From Baseline in AM NOW Nasal Congestion Score Averaged Over Days 2 to 15(Screening through 15 days daily)
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score at Endpoint (Last Post Baseline Evaluation Carried Forward)(Baseline and 15 days)