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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00783224
First received: October 30, 2008
Last updated: May 1, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Perennial Allergic Rhinitis
Drug: Placebo for MF
Drug: Placebo for FP
Drug: Mometasone
Drug: Fluticasone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Comparative Study of Mometasone Furoate Nasal Spray and Fluticasone Propionate Nasal Spray in Patients With Perennial Allergic Rhinitis

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome 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 ] [ Designated as safety issue: No ]
    The nasal symptoms (sneezing attacks, rhinorrhea, nasal congestion and itching) were rated in 4 grades (+++: 3 points, ++: 2 points, +: 1 point, -: 0 point) based on the evaluation criteria for nasal symptoms. Total possible best score is 0 points, total possible worst score is 12 points.


Enrollment: 351
Study Start Date: September 2005
Study Completion Date: December 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Mometasone Furoate Placebo (PLAMF)
Placebo to mometasone furoate nasal spray, made to be indistinguishable from mometasone furoate nasal spray
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
Placebo Comparator: Fluticasone Propionate Placebo (PLAFP)
Placebo to fluticasone propionate nasal spray, made to be indistinguishable from fluticasone propionate nasal spray
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
Experimental: Mometasone Furoate (MF)
Mometasone furoate nasal spray 200 μg/day(QD)
Drug: Mometasone
Mometasone furoate nasal spray. Patients in this arm take 2 sprays per nostril once a day for 2 weeks
Other Names:
  • SCH 032088
  • Nasonex
Active Comparator: Fluticasone Propionate (FP)
Fluticasone Propionate nasal spray 200 μg/day, twice per day (BID)
Drug: Fluticasone
Fluticasone propionate nasal spray. Patients in this arm take 2 sprays per nostril twice a day for 2 weeks
Other Name: Flonase

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00783224     History of Changes
Other Study ID Numbers: P04512
Study First Received: October 30, 2008
Results First Received: April 15, 2010
Last Updated: May 1, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Mometasone furoate
Fluticasone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Allergic Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on August 01, 2014