Efficacy and Safety of Concurrent Administration of Mometasone Furoate Nasal Spray (MFNS) and Oxymetazoline Nasal Spray Administered Once Daily (QD) vs. Oxymetazoline Twice Daily (BID), Mometasone Furoate QD, and Placebo in the Treatment of Subjects with Seasonal Allergic Rhinitis

Schering-Plough Research Institute, a Division of Schering Corporation0 sites875 target enrollmentFebruary 24, 2015

DrugsNasonex Afrin

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Schering-Plough Research Institute, a Division of Schering Corporation
Enrollment: 875
Status: Active, not recruiting
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 24, 2015

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Schering-Plough Research Institute, a Division of Schering Corporation

Eligibility Criteria

Inclusion Criteria

•1\. A subject must be 12 years of age or older, of either sex, and of any race.
•2\. A subject must have at least a 2\-year documented history of SAR which exacerbates during the time period over which the subject will be participating.
•3\. At screening (Visit 1\), a subject must have a documented positive skin\-prick test response to an appropriate seasonal allergen appropriate to the geographical vicinity in which the study is being carried out and over the period of time the subject is participating. Immunoglobulin E (IgE)\-mediated
•hypersensitivity to a seasonal allergen (eg, prevailing trees and/or grasses) must be by a positive response to the skin prick test with wheal diameter at least 3 mm larger than diluent control after 20 minutes.
•4\. A subject must be clinically symptomatic at the Screening Visit based upon NOW (instantaneous) allergy signs/symptom scores: nasal rhinorrhea must be \=2, nasal congestion must be \=2, and TNSS must be \=6 (see Section 7\.6 for details).
•5\. A subject must be clinically symptomatic at the Baseline Visit based upon NOW (instantaneous) allergy signs/symptom scores. For the 3 calendar days immediately before the Baseline Visit, the 7 twice\-daily (AM plus PM, plus AM of the Baseline Visit) run\-in diary NOW rhinorrhea score must be \=14, nasal
•congestion score must be \=14, and TNSS must total \=42\.
•6\. A subject must be in general good health as confirmed by routine clinical and laboratory testing and ECG results. Clinical laboratory tests (complete blood count \[CBC], blood chemistries, and urinalysis) must be within normal limits or clinically acceptable to the investigator and the sponsor.
•7\. A subject must be free of any clinically significant disease, other than SAR, which would interfere with the study evaluations.
•8\. 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 study requirements.

Exclusion Criteria

•1\. A subject with a history of anaphylaxis and/or other severe local reaction(s) to skin testing.
•2\. A subject with asthma who require chronic use of inhaled or systemic corticosteroids.
•3\. A subject with current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip.
•4\. A subject with rhinitis medicamentosa.
•5\. A subject with glaucoma and/or increased intraocular pressure.
•6\. A subject who received a monoamine oxidase (MAO) inhibitor, ß\-blocker or tricyclic antidepressants with 14 days of the Screening Visit.
•7\. A subject with a history of allergies to more than 2 classes of medications or who are allergic to or cannot tolerate nasal sprays.
•8\. 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 before the Screening Visit.
•9\. A subject who has nasal structural abnormalities, including large nasal polyps and marked septal deviations, which significantly interfere with nasal air flow.
•10\. A subject who, in the opinion of the investigator, is dependent on nasal, oral, or ocular decongestants, nasal topical antihistamines, or nasal steroids.