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

Last updated: January 14, 2021
Sponsor: Sandoz
Overall Status: Completed

Phase

3

Condition

Allergy

Common Cold

Nasal Obstruction

Treatment

N/A

Clinical Study ID

NCT01038427
70947201
  • Ages > 12
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 inseason at the time the study is being conducted.
  • Signed informed consent form. For patients under the age of majority the parent orlegal guardian should sign the consent form and the child will be required to sign apatient "assent" form.
  • Documented positive allergic skin test to local pollen, performed within the past 12months.
  • A score of at least 6 on the reflective Total Nasal Symptom Score (rTNSS) with aminimum score of at least 2 for "nasal congestion" and a minimum score of at least 2for one of the remaining 3 symptoms.

Exclusion

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 theexception of occasional acute or mild exercise induced asthma).
  • Patients with some nasal conditions, or with clinically significant nasal deformity orany recent nasal surgery or trauma that has not completely healed.
  • Upper respiratory tract infection or any untreated infections within the previous 30days.
  • Patient has started immunotherapy/changed the dose within 30 days of starting thestudy or has desensitization therapy to the seasonal allergen that is causing theallergic 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 thediagnosis of seasonal allergic rhinitis within 14 days of enrollment.
  • The patient has had recent exposure (30 days) or was at risk of being exposed tochicken pox or measles.
  • Any known hypersensitivity to mometasone, other steroids or any of the components ofthe study nasal spray.
  • Planned travel outside of the local area for more than 2 consecutive days or 3 days intotal.
  • The patient has a history of alcohol or drug abuse.

Study Design

Total Participants: 795
Study Start date:
December 02, 2009
Estimated Completion Date:
February 16, 2010

Study Description

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.

Connect with a study center

  • Austin, Texas 78759
    United States

    Site Not Available

  • Kerrville, Texas 78028
    United States

    Site Not Available

  • Live Oak, Texas 78233
    United States

    Site Not Available

  • New Braunfels, Texas 78310
    United States

    Site Not Available

  • Sylvana Research

    San Antonio, Texas 78229
    United States

    Site Not Available

  • San Antonio, Texas 78229
    United States

    Site Not Available

  • Waco, Texas 76708
    United States

    Site Not Available

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