Assessment of Intranasal Steroids in Allergic Rhinitis When Used Alone or in Combination With an Oral Antihistamine (Study P03270)

NCT ID: NCT00834119

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-09-01
• Study Completion Date: 2004-04-01

Brief Summary

This is a Phase 4, non-comparative, open-label, multi-center study. It is designed to determine the effectiveness of regular intranasal steroid use in alleviating allergic rhinitis nasal symptoms, when used alone or in combination with an oral antihistamine. Subjects will receive 200 mcg (2 puffs in each nostril) of mometasone furoate once a day. An oral antihistamine at the discretion of the physician may be added at Day 28 (Visit 2), if patients fail to improve nasal symptoms.

Conditions

Rhinitis, Allergic

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mometasone furoate

Group Type: EXPERIMENTAL

Mometasone furoate

Intervention Type: DRUG

Mometasone furoate 200 mcg (2 puffs in each nostril) once a day for 28 days

Mometasone furoate plus an oral antihistamine

Group Type: EXPERIMENTAL

Mometasone furoate

Intervention Type: DRUG

Mometasone furoate 200 mcg (2 puffs in each nostril) once a day plus an oral antihistamine added at Day 28 (Visit 2) at the discretion of the physician

Interventions

Mometasone furoate

Mometasone furoate 200 mcg (2 puffs in each nostril) once a day for 28 days

Intervention Type: DRUG

Mometasone furoate

Mometasone furoate 200 mcg (2 puffs in each nostril) once a day plus an oral antihistamine added at Day 28 (Visit 2) at the discretion of the physician

Intervention Type: DRUG

Other Intervention Names

Nasonex; SCH 32088; Nasonex; SCH 32088

Eligibility Criteria

Inclusion Criteria

• Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent form
• Subjects must be between 18-65 years of age, of either sex and any race
• Subjects must be diagnosed by the physician to have moderate to severe allergic rhinitis according to ARIA guidelines.
• Subjects must be mometasone furoate naïve.

Exclusion Criteria

• Significant comorbid medical condition.
• Respiratory tract infection.
• Any contraindications according to mometasone furoate product monograph.
• Patients who have received antihistamine treatment within the last 5 days.
• Patients who have received corticosteroid treatment within the last 30 days.
• Patients who are likely to require the administration of systemic steroids during the course of this program.
• Any condition which in the doctor's opinion could interfere with the patient completion of this program.
• Pregnant or lactating patients.
• Patients with local infections involving the nasal mucosa.
• Patients with structural abnormalities or who have undergone nasal surgery or trauma in the past 6 months.
• Patients with hypersensitivity to mometasone furoate or are allergic to corticosteroids.
• Patients who are prone to nose bleeding.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

P03270

Identifier Type: -

Identifier Source: org_study_id