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.
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
