A Comparative Study of Mometasone Furoate Nasal Spray and Fluticasone Propionate Nasal Spray in Patients With Perennial Allergic Rhinitis (Study P04512)

Official Title: “Comparative Study of Mometasone Furoate Nasal Spray and Fluticasone Propionate Nasal Spray in Patients With Perennial Allergic Rhinitis”

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.

Intervention(s) in this Clinical Trial

• Drug: Placebo for MF
  • 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
• Drug: Placebo for FP
  • 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
• Drug: Mometasone
  • Mometasone furoate nasal spray. Patients in this arm take 2 sprays per nostril once a day for 2 weeks
• Drug: Fluticasone
  • Fluticasone propionate nasal spray. Patients in this arm take 2 sprays per nostril twice a day for 2 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: Mometasone Furoate Placebo (PLAMF)
  • Placebo to mometasone furoate nasal spray, made to be indistinguishable from mometasone furoate nasal spray
• Placebo Comparator: Fluticasone Propionate Placebo (PLAFP)
  • Placebo to fluticasone propionate nasal spray, made to be indistinguishable from fluticasone propionate nasal spray
• Experimental: Mometasone Furoate (MF)
  • Mometasone furoate nasal spray 200 μg/day(QD)
• Active Comparator: Fluticasone Propionate (FP)
  • Fluticasone Propionate nasal spray 200 μg/day, twice per day (BID)

Primary Measures

• Change in 4 Nasal Symptom Score (Sneezing Attack, Rhinorrhea, Nasal Congestion, and Nasal Itching) After 2 Weeks
  • Time Frame: Baseline to 2 weeks of treatment
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 16 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Schering-Plough Industry

Information obtained from ClinicalTrials.gov on February 08, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00783224

Study ID Number: P04512

ClinicalTrials.gov Identifier: NCT00783224

Health Authority: Japan: Pharmaceuticals and Medical Devices Agency