A Study of Mometasone Furoate Nasal Spray in Perennial Allergic Rhinitis (Study P03748)(COMPLETED)

February 7, 2022 updated by: Organon and Co

Dose Finding and Dose Regimen Study of Mometasone Furoate Nasal Spray in Perennial Allergic Rhinitis

This is a multicenter, randomized, double-blind within the dose level, parallel group comparison of mometasone furoate nasal spray in subjects with perennial allergic rhinitis to examine the minimal effective dose, the recommended dose, and the dosing regimen.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

455

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients of mongoloid race residing in Japan who satisfy all of the following criteria:

    • Patients having symptoms of allergic rhinitis of moderate or severe degree, according to the classification of severity in the guidelines for the treatment of nasal allergy (partial revision) as well as a score of at least 4 in the score of 4 nasal symptoms, at the time of obtaining the informed consent during the pretreatment observation period.
    • Patients in whom the skin or specific IgE test is positive and the cytological examination for eosinophils in nasal discharge or nasal challenge test is positive.
    • Out-patients aged 16 years or over at the time of obtaining the informed consent.
    • Male or female.
    • Patients from whom the informed consent can be obtained in writing (or the informed consent can be obtained from the patient's legally acceptable representative, if under 20 years).
    • Patients who can daily complete the nasal allergy diary.

Exclusion Criteria:

  • Patients who meet any of the following exclusion criteria are not included in the present study:

    • Patients with a complication of tuberculous disease or lower respiratory tract infection, or patients with a complication of acute upper respiratory tract inflammation or acute laryngopharyngitis which the (sub) investigator considers necessary to treat at the time of enrollment in the treatment.
    • Patients with a complication of infection or systemic mycosis for which no effective antibiotics are available.
    • Patients with unhealed nasal septum ulcer, nasal surgery, or nasal trauma.
    • Patients with hypersensitivity to steroids and mometasone furoate.
    • Patients who are pregnant, nursing, or possibly pregnant, or who desire to become pregnant during the study period.
    • Patients with severe hepatic, renal, or cardiac disorder, blood disease, diabetes, hypertension, or other serious complication, suffering from problems with systemic condition.
    • Patients in whom pollen is an overlapping allergen and the study is planned to be implemented in the pollen release season.
    • Patients with a complication of vasomotor rhinitis or eosinophilic rhinitis.
    • Patients with a complication of nose disease which may interfere with efficacy evaluation of the investigational product.
    • Patients who were complicated by acute upper respiratory tract inflammation during the 7-day observation period prior to enrollment which may affect the nasal symptoms.
    • Patients who have previously received mometasone furoate nasal spray.
    • Patients who have participated in clinical trial of other investigational product(s) within 4 months before obtaining the informed consent or are participating at present.
    • Patients in whom prior medication effective against allergic rhinitis was withdrawn not 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 3 months before obtaining the informed consent (except for patients receiving the maintenance therapy at present in whom the therapy began more than 6 months before obtaining the informed consent).
    • Other patients whom the (sub) investigator judged to be inappropriate for participation in the present study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
The placebo group was divided into 3 groups receiving 1, 2 or 4 sprays/nostril. The regimen of each placebo group was BID
Drug: Placebo
One, two, or four sprays of placebo are administered to the left and right nostrils twice a day (in the morning and at night) for 2 weeks.
Experimental: Mometasone furoate nasal spray 100 mcg QD
Drug: Placebo
One, two, or four sprays of placebo are administered to the left and right nostrils twice a day (in the morning and at night) for 2 weeks.
Drug: Mometasone furoate
One spray of mometasone furoate 50 mcg is administered to the left and right nostrils in the morning, and one spray of placebo to the left and right nostrils at night for 2 weeks. The daily dose of mometasone furoate is 100 mcg.
Other Names:
  • SCH 32088
  • Nasonex
Drug: Mometasone furoate
Two sprays of mometasone furoate 50 mcg are administered to the left and right nostrils in the morning, and two sprays of placebo to the left and right at night for 2 weeks. The daily dose of mometasone furoate is 200 mcg.
Other Names:
  • SCH 32088
  • Nasonex
Drug: Mometasone furoate
Four sprays of mometasone furoate 50 mcg are administered to the left and right nostrils in the morning, and four sprays of placebo to the left and right nostrils at night for 2 weeks. The daily dose of mometasone furoate is 400 mcg.
Other Names:
  • SCH 32088
  • Nasonex
Drug: Mometasone furoate
One spray of mometasone furoate 50 mcg is administered to the left and right nostrils twice a day (in the morning and at night) for 2 weeks. The daily dose of mometasone furoate is 200 mcg.
Other Names:
  • SCH 32088
  • Nasonex
Drug: Mometasone furoate
Two sprays of mometasone furoate 50 mcg are administered to the left and right nostrils twice a day (in the morning and at night) for 2 weeks. The daily dose of mometasone furoate is 400 mcg.
Other Names:
  • SCH 32088
  • Nasonex
Experimental: Mometasone furoate nasal spray 200 mcg QD
Drug: Placebo
One, two, or four sprays of placebo are administered to the left and right nostrils twice a day (in the morning and at night) for 2 weeks.
Drug: Mometasone furoate
One spray of mometasone furoate 50 mcg is administered to the left and right nostrils in the morning, and one spray of placebo to the left and right nostrils at night for 2 weeks. The daily dose of mometasone furoate is 100 mcg.
Other Names:
  • SCH 32088
  • Nasonex
Drug: Mometasone furoate
Two sprays of mometasone furoate 50 mcg are administered to the left and right nostrils in the morning, and two sprays of placebo to the left and right at night for 2 weeks. The daily dose of mometasone furoate is 200 mcg.
Other Names:
  • SCH 32088
  • Nasonex
Drug: Mometasone furoate
Four sprays of mometasone furoate 50 mcg are administered to the left and right nostrils in the morning, and four sprays of placebo to the left and right nostrils at night for 2 weeks. The daily dose of mometasone furoate is 400 mcg.
Other Names:
  • SCH 32088
  • Nasonex
Drug: Mometasone furoate
One spray of mometasone furoate 50 mcg is administered to the left and right nostrils twice a day (in the morning and at night) for 2 weeks. The daily dose of mometasone furoate is 200 mcg.
Other Names:
  • SCH 32088
  • Nasonex
Drug: Mometasone furoate
Two sprays of mometasone furoate 50 mcg are administered to the left and right nostrils twice a day (in the morning and at night) for 2 weeks. The daily dose of mometasone furoate is 400 mcg.
Other Names:
  • SCH 32088
  • Nasonex
Experimental: Mometasone furoate nasal spray 400 mcg QD
Drug: Placebo
One, two, or four sprays of placebo are administered to the left and right nostrils twice a day (in the morning and at night) for 2 weeks.
Drug: Mometasone furoate
One spray of mometasone furoate 50 mcg is administered to the left and right nostrils in the morning, and one spray of placebo to the left and right nostrils at night for 2 weeks. The daily dose of mometasone furoate is 100 mcg.
Other Names:
  • SCH 32088
  • Nasonex
Drug: Mometasone furoate
Two sprays of mometasone furoate 50 mcg are administered to the left and right nostrils in the morning, and two sprays of placebo to the left and right at night for 2 weeks. The daily dose of mometasone furoate is 200 mcg.
Other Names:
  • SCH 32088
  • Nasonex
Drug: Mometasone furoate
Four sprays of mometasone furoate 50 mcg are administered to the left and right nostrils in the morning, and four sprays of placebo to the left and right nostrils at night for 2 weeks. The daily dose of mometasone furoate is 400 mcg.
Other Names:
  • SCH 32088
  • Nasonex
Drug: Mometasone furoate
One spray of mometasone furoate 50 mcg is administered to the left and right nostrils twice a day (in the morning and at night) for 2 weeks. The daily dose of mometasone furoate is 200 mcg.
Other Names:
  • SCH 32088
  • Nasonex
Drug: Mometasone furoate
Two sprays of mometasone furoate 50 mcg are administered to the left and right nostrils twice a day (in the morning and at night) for 2 weeks. The daily dose of mometasone furoate is 400 mcg.
Other Names:
  • SCH 32088
  • Nasonex
Experimental: Mometasone furoate nasal spray 100 mcg BID
Drug: Mometasone furoate
One spray of mometasone furoate 50 mcg is administered to the left and right nostrils in the morning, and one spray of placebo to the left and right nostrils at night for 2 weeks. The daily dose of mometasone furoate is 100 mcg.
Other Names:
  • SCH 32088
  • Nasonex
Drug: Mometasone furoate
Two sprays of mometasone furoate 50 mcg are administered to the left and right nostrils in the morning, and two sprays of placebo to the left and right at night for 2 weeks. The daily dose of mometasone furoate is 200 mcg.
Other Names:
  • SCH 32088
  • Nasonex
Drug: Mometasone furoate
Four sprays of mometasone furoate 50 mcg are administered to the left and right nostrils in the morning, and four sprays of placebo to the left and right nostrils at night for 2 weeks. The daily dose of mometasone furoate is 400 mcg.
Other Names:
  • SCH 32088
  • Nasonex
Drug: Mometasone furoate
One spray of mometasone furoate 50 mcg is administered to the left and right nostrils twice a day (in the morning and at night) for 2 weeks. The daily dose of mometasone furoate is 200 mcg.
Other Names:
  • SCH 32088
  • Nasonex
Drug: Mometasone furoate
Two sprays of mometasone furoate 50 mcg are administered to the left and right nostrils twice a day (in the morning and at night) for 2 weeks. The daily dose of mometasone furoate is 400 mcg.
Other Names:
  • SCH 32088
  • Nasonex
Experimental: Mometasone furoate nasal spray 200 mcg BID
Drug: Mometasone furoate
One spray of mometasone furoate 50 mcg is administered to the left and right nostrils in the morning, and one spray of placebo to the left and right nostrils at night for 2 weeks. The daily dose of mometasone furoate is 100 mcg.
Other Names:
  • SCH 32088
  • Nasonex
Drug: Mometasone furoate
Two sprays of mometasone furoate 50 mcg are administered to the left and right nostrils in the morning, and two sprays of placebo to the left and right at night for 2 weeks. The daily dose of mometasone furoate is 200 mcg.
Other Names:
  • SCH 32088
  • Nasonex
Drug: Mometasone furoate
Four sprays of mometasone furoate 50 mcg are administered to the left and right nostrils in the morning, and four sprays of placebo to the left and right nostrils at night for 2 weeks. The daily dose of mometasone furoate is 400 mcg.
Other Names:
  • SCH 32088
  • Nasonex
Drug: Mometasone furoate
One spray of mometasone furoate 50 mcg is administered to the left and right nostrils twice a day (in the morning and at night) for 2 weeks. The daily dose of mometasone furoate is 200 mcg.
Other Names:
  • SCH 32088
  • Nasonex
Drug: Mometasone furoate
Two sprays of mometasone furoate 50 mcg are administered to the left and right nostrils twice a day (in the morning and at night) for 2 weeks. The daily dose of mometasone furoate is 400 mcg.
Other Names:
  • SCH 32088
  • Nasonex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in 4 nasal symptom score (sneezing attack, rhinorrhea, nasal congestion, and nasal itching) from baseline at Week 2
Time Frame: After 2 weeks of treatment
After 2 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in each nasal symptom (sneezing attack, rhinorrhea, nasal congestion, and nasal itching)
Time Frame: After 1 and 2 weeks of treatment
After 1 and 2 weeks of treatment
Overall improvement
Time Frame: After 1 and 2 weeks of treatment
After 1 and 2 weeks of treatment
QOL score
Time Frame: At initial day of treatment and after 2 weeks of treatment
At initial day of treatment and after 2 weeks of treatment
Adverse events
Time Frame: From initial day of treatment until 7-10 days after treatment is stopped.
From initial day of treatment until 7-10 days after treatment is stopped.
Laboratory tests
Time Frame: From initial day of treatment until treatment is stopped.
From initial day of treatment until treatment is stopped.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2004

Primary Completion (Actual)

August 6, 2004

Study Completion (Actual)

August 6, 2004

Study Registration Dates

First Submitted

October 23, 2008

First Submitted That Met QC Criteria

October 23, 2008

First Posted (Estimate)

October 24, 2008

Study Record Updates

Last Update Posted (Actual)

February 16, 2022

Last Update Submitted That Met QC Criteria

February 7, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P03748
  • JPC-03-342-20

Plan for Individual participant data (IPD)

Study Data/Documents

  1. CSR Synopsis

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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