Safety and Efficacy of Mometasone Furoate Nasal Spray With the Addition of Loratadine Versus Placebo in Participants With Seasonal Allergic Rhinitis (C94-145)
Condition: Rhinitis, Allergic
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Mometasone furoate nasal spray (MFNS); Loratadine; Placebo nasal spray; Placebo tablet
Intervention description: Daily dose of 200 µg of mometasone furoate administered as a nasal spray for 15 days.; Daily dose of 10 mg of loratadine administered as an oral tablet for 15 days.; Daily dose of placebo administered as a nasal spray for 15 days.; Daily dose of placebo administered as an oral tablet for 15 days.
Intervention MeSH terms: Mometasone Furoate; Loratadine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 704.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of mometasone furoate nasal
      spray (MFNS) with the addition of loratadine vs MFNS alone, loratadine alone, or placebo, in
      the treatment of patients with seasonal allergic rhinitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  2-year history of seasonal allergic rhinitis

          -  Positive skin test response to a local seasonal allergen (current, or performed in
             investigator's office within the past year)

          -  Good health and free of any unstable, clinically significant disease, other than
             allergic rhinitis, that would interfere with the study schedule or evaluation of
             seasonal allergic rhinitis

        Exclusion Criteria:

          -  Women who are pregnant or breastfeeding

          -  Women of childbearing potential who are not using an acceptable form of birth control

          -  Significant history of metabolic, cardiovascular, neurologic, hematologic, hepatic,
             gastrointestinal, cerebrovascular, respiratory, or renal disease, or any other
             disorder which, in the judgment of the investigator, could interfere with the study,
             or require treatment which might interfere with the study

          -  Use of any chronic medication which could affect the course of seasonal allergic
             rhinitis

          -  Asthma requiring chronic use of inhaled or systemic corticosteroids (inhaled
             bronchodilators are permitted for asthma treatment)

          -  Current or history of frequent, clinically significant sinusitis or chronic purulent
             postnasal drip

          -  Upper respiratory tract or sinus infection that requires antibiotic therapy within the
             previous 2 weeks, or a viral upper respiratory infection (URI) within the 7 days prior
             to Screening

          -  Dependence upon nasal, oral or ocular decongestants, or nasal topical antihistamines,
             in the opinion of the investigator

          -  Has rhinitis medicamentosa

          -  Evidence of clinically significant nasal candidiasis

          -  Investigational drug use within the previous 30 days

          -  Nasal structural abnormalities, including large nasal polyps and marked septal
             deviation, that significantly interfere with nasal air flow

          -  Immunotherapy (desensitization therapy), unless on a stable maintenance schedule for
             at least one month prior to the Screening visit

          -  History of multiple drug allergies, allergy to antihistamines or corticoids

          -  History of psychosis, antagonistic personality, poor motivation, hypochondriasis, or
             any other emotional or intellectual problems that are likely to limit the validity of
             consent to participate in the study