Mometasone Furoate Aqueous (MK-0887/SCH 032088) Nasal Spray vs Placebo and FLONASE® in Seasonal Allergic Rhinitis Patients (I94-001)
Condition: Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Mometasone furoate; Fluticasone propionate; Mometasone furoate placebo; Fluticasone propionate placebo
Intervention description: Mometasone furoate nasal spray, 200 mg once daily; Fluticasone propionate nasal spray, 200 mg once daily; Mometasone furoate placebo matching nasal spray, once daily; Fluticasone propionate placebo matching nasal spray, once daily
Intervention MeSH terms: Fluticasone; Xhance; Mometasone Furoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Both participant and investigator were blinded to treatment identity. Because the mometasone furoate and fluticasone propionate bottles were not identical in appearance, a double-dummy study design was used and each bottle had a matching placebo. Thus, although participants received bottles of different appearance, they did not know whether bottles contained active substance or placebo.
Enrollment: 313.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy and safety of mometasone furoate (SCH
      32088) aqueous nasal spray 200 mcg once daily compared to placebo once daily in the treatment
      of participants with seasonal allergic rhinitis. Flonase (fluticasone propionate) nasal spray
      200 mcg once daily has been chosen as the active control for this study.
    

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

          -  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