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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

795 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-02

Study Completion Date

2010-02-16

Brief Summary

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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.

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Detailed Description

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The study was designed as a double-blind, randomized, placebo-controlled, parallel group, multi-site to compare the clinical equivalence of the test formulation of mometasone furoate monohydrate, 50 mcg/actuation nasal spray (Lek Pharmaceuticals d.d.) with the reference formulation Nasonex® nasal spray (Schering) in the relief of the signs and symptoms of seasonal allergic rhinitis. Participants who met the inclusion/exclusion criteria entered a 7-day placebo lead-in period. Following this placebo lead-in period, on Day 1 participants who continued to meet eligibility criteria were randomly assigned in a 2:2:1 ratio to one of three treatment groups (Test Product:Reference Product:Placebo) for 14 days of treatment. In all treatment groups, participants were instructed to administer the study drug once daily at approximately the same time each day. A single dose of 200 mcg was 4 actuations, each containing 50 mcg per actuation. Patients were instructed to administer the 4 actuations alternating between right and left nostril, such that 2 actuations were not administered back to back to the same nostril.

Conditions

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Rhinitis, Allergic, Seasonal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Test

Mometasone furoate 50 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 200 mcg (4 actuations) for 14 days.

Group Type EXPERIMENTAL

Mometasone furoate 50 mcg/actuation nasal spray (Lek Pharmaceuticals)

Intervention Type DRUG

Mometasone nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days.

Reference

Mometasone furoate (Nasonex®) 50 mcg/actuation nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days.

Group Type ACTIVE_COMPARATOR

Mometasone furoate (Nasonex®) 50 mcg/actuation nasal spray

Intervention Type DRUG

Mometasone nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days.

Placebo

Placebo nasal spray administered once daily for 14 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo nasal spray administered once daily (4 actuations) for 14 days.

Interventions

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Mometasone furoate (Nasonex®) 50 mcg/actuation nasal spray

Mometasone nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days.

Intervention Type DRUG

Placebo

Placebo nasal spray administered once daily (4 actuations) for 14 days.

Intervention Type DRUG

Mometasone furoate 50 mcg/actuation nasal spray (Lek Pharmaceuticals)

Mometasone nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No