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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rhinitis, Allergic, Perennial

Intervention: Placebo (Drug); Mometasone furoate (Drug); Mometasone furoate (Drug); Mometasone furoate (Drug); Mometasone furoate (Drug); Mometasone furoate (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change in 4 nasal symptom score (sneezing attack, rhinorrhea, nasal congestion, and nasal itching) from baseline at Week 2

Secondary outcome:

Change in each nasal symptom (sneezing attack, rhinorrhea, nasal congestion, and nasal itching)

Overall improvement

QOL score

Adverse events

Laboratory tests

Eligibility

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Additional Information

Starting date: April 2004
Last updated: April 8, 2015

Page last updated: August 23, 2015

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