A Study Comparing the Clinical Equivalence of Two Mometasone Nasal Sprays in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis

• Status: Completed
• Trial end date: 2010-02-16
• Target enrollment: 0
• Participant gender: All

Summary

This study compared the efficacy and safety of a generic mometasone nasal spray to the reference listed drug in the treatment of seasonal allergic rhinitis. Additionally both the test and the reference formulations were tested for superiority against a placebo nasal spray.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sandoz
• Treatments: Mometasone Furoate

Criteria

Inclusion Criteria:

• Male or non-pregnant, non-lactating female 12 years of age or older with a minimum of 2 years of previous history of seasonal allergic rhinitis to the pollen/allergen in season at the time the study is being conducted.

• Signed informed consent form. For patients under the age of majority the parent or legal guardian should sign the consent form and the child will be required to sign a patient "assent" form.

• Documented positive allergic skin test to local pollen, performed within the past 12 months.

• A score of at least 6 on the reflective Total Nasal Symptom Score (rTNSS) with a minimum score of at least 2 for "nasal congestion" and a minimum score of at least 2 for one of the remaining 3 symptoms.

Exclusion Criteria:

• Females who are pregnant, lactating or likely to become pregnant during the study.

• History of asthma over the previous two years that required chronic therapy (with the exception of occasional acute or mild exercise induced asthma).

• Patients with some nasal conditions, or with clinically significant nasal deformity or any recent nasal surgery or trauma that has not completely healed.

• Upper respiratory tract infection or any untreated infections within the previous 30 days.

• Patient has started immunotherapy/changed the dose within 30 days of starting the study or has desensitization therapy to the seasonal allergen that is causing the allergic rhinitis within the previous 6 months.

• Patients with a history of tuberculosis, or with the presence of glaucoma, cataracts, ocular herpes simplex, conjunctivitis or other eye infection not related to the diagnosis of seasonal allergic rhinitis within 14 days of enrollment.

• The patient has had recent exposure (30 days) or was at risk of being exposed to chicken pox or measles.

• Any known hypersensitivity to mometasone, other steroids or any of the components of the study nasal spray.

• Planned travel outside of the local area for more than 2 consecutive days or 3 days in total.

• The patient has a history of alcohol or drug abuse.