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
Conditions:Allergy
Therapuetic Areas:Otolaryngology
Healthy:No
Age Range:12 - Any
Updated:3/29/2017
Start Date:December 2009
End Date:February 2010

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A Double-Blind, Randomized, Placebo Controlled, Parallel Group, Multi-Site Study to Compare the Clinical Equivalence of Mometasone Nasal Spray (Lek Pharmaceuticals) With NASONEX® Nasal Spray (Schering Corporation) in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis

This study will compare the safety and efficacy 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 will be tested for superiority against a placebo nasal
spray.


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.
We found this trial at
7
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New Braunfels, TX
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San Antonio, Texas
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San Antonio, TX
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Waco, TX
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