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

NCT00779545 | Completed Phase 2

• 2 other identifiers: P03748JPC-03-342-20
• Study Type: interventional
• Target: 455
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Rhinitis, Allergic, Perennial

Outcome Measures

Primary Outcomes (1)

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

  After 2 weeks of treatment

Secondary Outcomes (5)

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

  After 1 and 2 weeks of treatment

• Overall improvement

  After 1 and 2 weeks of treatment

• QOL score

  At initial day of treatment and after 2 weeks of treatment

• Adverse events

  From initial day of treatment until 7-10 days after treatment is stopped.

• Laboratory tests

  From initial day of treatment until treatment is stopped.

Study Arms (6)

Placebo

PLACEBO COMPARATOR

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

Mometasone furoate nasal spray 100 mcg QD

EXPERIMENTAL

Drug: Placebo; Drug: Mometasone furoate

Mometasone furoate nasal spray 200 mcg QD

EXPERIMENTAL

Drug: Placebo; Drug: Mometasone furoate

Mometasone furoate nasal spray 400 mcg QD

EXPERIMENTAL

Drug: Placebo; Drug: Mometasone furoate

Mometasone furoate nasal spray 100 mcg BID

EXPERIMENTAL

Drug: Mometasone furoate

Mometasone furoate nasal spray 200 mcg BID

EXPERIMENTAL

Drug: Mometasone furoate

Interventions

Placebo DRUG

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.

Mometasone furoate nasal spray 100 mcg QD; Mometasone furoate nasal spray 200 mcg QD; Mometasone furoate nasal spray 400 mcg QD; Placebo

Mometasone furoate DRUG

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.

Also known as: Nasonex, SCH 32088

Mometasone furoate nasal spray 100 mcg QD

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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Organon and Co: lead

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Interventions

Mometasone Furoate

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2008
• First Posted: October 24, 2008
• Study Start: April 8, 2004
• Primary Completion: August 6, 2004
• Study Completion: August 6, 2004
• Last Updated: August 15, 2024

Record last verified: 2022-02