A Study Comparing the Clinical Equivalence of Two Mometasone Nasal Sprays in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis
Condition: Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Mometasone furoate 50 mcg/actuation nasal spray (Lek Pharmaceuticals); Mometasone furoate (Nasonex®) 50 mcg/actuation nasal spray; Placebo
Intervention description: Mometasone nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days.; Mometasone nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days.; Placebo nasal spray administered once daily (4 actuations) for 14 days.
Intervention MeSH terms: Mometasone Furoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 795.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Rhinitis; Seasonal Allergic Rhinitis; Mometasone Furoate; Equivalence; Hay fever

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 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.