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

NCT00783224 | Completed Phase 3 Results

• 1 other identifier: P04512
• Study Type: interventional
• Target: 351
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Perennial Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Change in 4 Nasal Symptom Score (Sneezing Attack, Rhinorrhea, Nasal Congestion, and Nasal Itching) After 2 Weeks

  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.

  Baseline to 2 weeks of treatment

Study Arms (4)

Mometasone Furoate Placebo (PLAMF)

PLACEBO COMPARATOR

Placebo to mometasone furoate nasal spray, made to be indistinguishable from mometasone furoate nasal spray

Drug: Placebo for MF

Fluticasone Propionate Placebo (PLAFP)

PLACEBO COMPARATOR

Placebo to fluticasone propionate nasal spray, made to be indistinguishable from fluticasone propionate nasal spray

Drug: Placebo for FP

Mometasone Furoate (MF)

EXPERIMENTAL

Mometasone furoate nasal spray 200 μg/day(QD)

Drug: Mometasone

Fluticasone Propionate (FP)

ACTIVE COMPARATOR

Fluticasone Propionate nasal spray 200 μg/day, twice per day (BID)

Drug: Fluticasone

Interventions

Placebo for MF DRUG

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

Mometasone Furoate Placebo (PLAMF)

Placebo for FP DRUG

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

Fluticasone Propionate Placebo (PLAFP)

Mometasone DRUG

Mometasone furoate nasal spray. Patients in this arm take 2 sprays per nostril once a day for 2 weeks

Also known as: SCH 032088, Nasonex

Mometasone Furoate (MF)

Fluticasone DRUG

Fluticasone propionate nasal spray. Patients in this arm take 2 sprays per nostril twice a day for 2 weeks

Also known as: Flonase

Fluticasone Propionate (FP)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• N. Sou et. al; Allergology & Immunology 16(3) page 394-413, (2009.02) -Japanese language journal

  RESULT

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Interventions

Mometasone Furoate; Fluticasone

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Androstadienes; Androstenes; Androstanes

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck, Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2008
• First Posted: October 31, 2008
• Study Start: September 1, 2005
• Primary Completion: November 1, 2005
• Study Completion: December 1, 2005
• Last Updated: February 9, 2022
• Results First Posted: July 12, 2010

Record last verified: 2022-02