A Comparative Study of Mometasone Furoate Nasal Spray and Fluticasone Propionate Nasal Spray in Patients With Perennial Allergic Rhinitis (Study P04512)
Condition: Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: Placebo for MF; Placebo for FP; Mometasone; Fluticasone
Intervention description: Placebo to mometasone furoate nasal spray, indistinguishable from mometasone furoate nasal spray. Patients in this arm take 2 sprays per nostril once a day for 2 weeks; Placebo to fluticasone nasal spray, indistinguishable from fluticasone propionate nasal spray. Patients in this arm take 2 sprays per nostril twice a day for 2 weeks; Mometasone furoate nasal spray. Patients in this arm take 2 sprays per nostril once a day for 2 weeks; Fluticasone propionate nasal spray. Patients in this arm take 2 sprays per nostril twice a day for 2 weeks
Intervention MeSH terms: Fluticasone; Mometasone Furoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 351.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No

Summary:

      This study was conducted to see if mometasone nasal spray is efficaceous for the treatment of
      perennial allergic rhinitis. Patients will be randomized to active mometasone, placebo
      mometasone, active fluticasone, or placebo fluticasone.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients with perennial allergic rhinitis meeting all of the followings.

          -  Patients with symptoms of perennial allergic rhinitis, the severity of which is
             moderate or severer according to the severity grading provided in the "Guidelines for
             the Management of Allergic Rhinitis in Japan" (partly modified) with the 4-nasal
             symptom score of 4 or over at informed consent and during the pre-treatment
             observation period

          -  Patients with positive reaction to the eosinophil count in nasal discharge or nasal
             challenge test in addition to the skin test or specific IgE antibody test

          -  Outpatients aged 16 years or over at informed consent

          -  Patients in either sex

          -  Patients (or their legal representatives in case of patients aged under 20 years)
             capable of giving written informed consent

          -  Patients capable of recording nasal allergy diary every day

        Exclusion Criteria:

          -  Patients with a complication of tuberculous diseases or lower respiratory tract
             infections, and those with a complication of otorhinolaryngeal infections(acute upper
             respiratory tract inflammation, acute laryngopharyngitis, acute tonsillitis, etc.)
             requiring treatments judged by the investigator (subinvestigator) at the time of
             enrollment to randomization

          -  Patients with a complication of infection or systemic mycosis for which no effective
             antibiotics are available

          -  Patients with a complication of recurrent epistaxis

          -  Patients with uncured nasal septal ulcer, operated nose or nasal trauma.

          -  Patients with a history of hypersensitivity to steroids and any ingredients of the
             study drugs

          -  Pregnant, lactating or possibly pregnant patients or the patients who themselves or
             whose partners wish to become pregnant during the study

          -  Patients with severe hepatic or renal disorder, heart or blood disease, diabetes
             mellitus, hypertension, or other serious complication, suffering from problems with
             systemic condition

          -  Patients who have pollens as multiple allergens and the period from 7 days before
             enrollment to randomization to completion of the treatment period coincides with the
             period of scattering of relevant pollens

          -  Patients with a complication of vasomotor rhinitis or eosinophilic rhinitis

          -  Patients with a complication of a nasal disease (infectious sinusitis, hypertrophic
             rhinitis, acute or chronic rhinitis, nasal polyps, or septal deviation) which may
             interfere with efficacy evaluation of the study drugs

          -  Patients with a complication of a disease (acute upper respiratory tract inflammation,
             acute laryngitis or acute tonsillitis, etc.) of severity affecting nasal symptoms
             within 7 days before enrollment

          -  Patients who have previously received MF nasal spray

          -  Patients who used FP nasal spray within 28 days before initiation of the pre-treatment
             observation period (7 days before enrollment to randomization)

          -  Patients who have participated in clinical trials of other investigational product(s)
             within 120 days (4 months) before obtaining informed consent or participating at
             present

          -  Patients in whom prior medication expected to be effective for allergic rhinitis was
             not drawn long enough before initiation of treatment with the investigational product
             or the preceding medication cannot be withdrawn

          -  Patients who are being treated with specific desensitization therapy or nonspecific
             allassotherapy or in whom such the therapy was withdrawn within 90 days (3 months)
             before obtaining informed consent (except for patients receiving the maintenance
             therapy at present in whom the therapy began more than 180 days (6 months) before
             obtaining the informed consent)

          -  Other patients whom the investigator or the subinvestigator judged to be inappropriate
             for participation in the present study