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

Phase 4

Completed

• Conditions: Rhinitis, Allergic
• Interventions: Drug: Mometasone furoate

• Registration Number: NCT00834119
• Lead Sponsor: Organon and Co

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09-01
• Primary Completion: 2004-04-01
• Study Completion: 2004-04-01
• Study First Submitted: 2008-10-30
• Study First Submitted QC: 2009-02-02
• Study First Posted: 2009-02-03
• Status Verified: 2022-02
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mometasone furoate	Mometasone furoate	-
Mometasone furoate plus an oral antihistamine	Mometasone furoate	-

Primary Outcome Measures

Name	Time	Method
To assess the mean change in total nasal symptom score from Baseline to the Final Visit of regular intranasal steroid use (mometasone furoate) in allergic rhinitis patients when used alone or in combination with an oral antihistamine.	Day 28 and Day 56

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction with intranasal steroid monotherapy.	Day 28
Potential benefit of an oral antihistamine in combination with an intranasal steroid	Day 56