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

Last updated: February 7, 2022
Sponsor: Organon and Co
Overall Status: Completed

Phase

3

Condition

Allergy

Common Cold

Rhinitis, Allergic, Perennial

Treatment

N/A

Clinical Study ID

NCT00783224
P04512
  • Ages > 16
  • All Genders

Study 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

Inclusion Criteria: Patients with perennial allergic rhinitis meeting all of the followings.

  • Patients with symptoms of perennial allergic rhinitis, the severity of which ismoderate or severer according to the severity grading provided in the "Guidelines forthe Management of Allergic Rhinitis in Japan" (partly modified) with the 4-nasalsymptom score of 4 or over at informed consent and during the pre-treatmentobservation period
  • Patients with positive reaction to the eosinophil count in nasal discharge or nasalchallenge 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

Exclusion Criteria:

  • Patients with a complication of tuberculous diseases or lower respiratory tractinfections, and those with a complication of otorhinolaryngeal infections(acute upperrespiratory tract inflammation, acute laryngopharyngitis, acute tonsillitis, etc.)requiring treatments judged by the investigator (subinvestigator) at the time ofenrollment to randomization
  • Patients with a complication of infection or systemic mycosis for which no effectiveantibiotics 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 thestudy drugs
  • Pregnant, lactating or possibly pregnant patients or the patients who themselves orwhose partners wish to become pregnant during the study
  • Patients with severe hepatic or renal disorder, heart or blood disease, diabetesmellitus, hypertension, or other serious complication, suffering from problems withsystemic condition
  • Patients who have pollens as multiple allergens and the period from 7 days beforeenrollment to randomization to completion of the treatment period coincides with theperiod 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, hypertrophicrhinitis, acute or chronic rhinitis, nasal polyps, or septal deviation) which mayinterfere 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 symptomswithin 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-treatmentobservation 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 atpresent
  • Patients in whom prior medication expected to be effective for allergic rhinitis wasnot drawn long enough before initiation of treatment with the investigational productor the preceding medication cannot be withdrawn
  • Patients who are being treated with specific desensitization therapy or nonspecificallassotherapy or in whom such the therapy was withdrawn within 90 days (3 months)before obtaining informed consent (except for patients receiving the maintenancetherapy at present in whom the therapy began more than 180 days (6 months) beforeobtaining the informed consent)
  • Other patients whom the investigator or the subinvestigator judged to be inappropriatefor participation in the present study

Study Design

Total Participants: 351
Study Start date:
September 01, 2005
Estimated Completion Date:
December 31, 2005