Equivalency Study of Two Formulations of Mometasone Furoate Nasal Spray (Study P04419)

Exclusion Criteria

• •Patients with coexisting tuberculous disease or lower respiratory tract infection, or patients who, at the time of registration, have acute upper respiratory tract infection, acute pharyngitis, acute amygdalitis etc.
• •Patients with coexisting infections or systemic mycosis for which there are no effective antibiotics.
• •Patients with unhealed nasal septum ulcers, nasal surgery scar, or nasal trauma.
• •Patients with a history of hypersensitivity to steroids or mometasone furoate.
• •Patients who are pregnant or nursing or who may be pregnant and patients or patients' partners who desire to become pregnant during the study period.
• •Patients with severe hepatic, renal, cardiac, hematological disease, diabetes mellitus, hypertension or other serious coexisting diseases and whose general condition is poor.
• •Patients also allergic to pollen and the pollen release season occurs during the study period.
• •Patients with vasomotor rhinitis or eosinophilic rhinitis.
• •Patients with a nasal condition which may interfere with efficacy evaluation of the investigational product.
• •Patients who develop disease affecting nasal symptoms during the pretreatment observation period, i.e., during the 7 days before actual registration.
• •Patients who are participating or have participated in a clinical trial of another investigational drug within 120 days (4 months) before the day of the informed consent for this study.
• •Patients for whom the period of discontinuation of previous treatment effective for allergic rhinitis before the start of the investigational product administration is not sufficient or who cannot avoid its use.
• •Patients receiving specific desensitization therapy or nonspecific modulation therapy or who had just discontinued such therapies within 90 days (3 months) before providing consent to this study (unless such therapies are ongoing as maintenance therapy and had been started 180 days \[6 months\] or more before consent to this study).
• •Other patients judged inappropriate for study by the investigator or subinvestigator.