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

Assessment of the Effectiveness of Regular Use of Intranasal Steroids in Alleviating Nasal Symptoms in Allergic Rhinitis When Used Alone or in Combination With Oral Antihistamine

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.

Study Overview

• Status: Completed
• Conditions: Rhinitis, Allergic
• Intervention / Treatment: Drug: Mometasone furoate; Drug: Mometasone furoate

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mometasone furoate	Drug: Mometasone furoate; Mometasone furoate 200 mcg (2 puffs in each nostril) once a day for 28 days; Other Names: SCH 32088; Nasonex; 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; Other Names: SCH 32088; Nasonex
Experimental: Mometasone furoate plus an oral antihistamine	Drug: Mometasone furoate; Mometasone furoate 200 mcg (2 puffs in each nostril) once a day for 28 days; Other Names: SCH 32088; Nasonex; 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; Other Names: SCH 32088; Nasonex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Patient satisfaction with intranasal steroid monotherapy.	Day 28
Potential benefit of an oral antihistamine in combination with an intranasal steroid	Day 56

Collaborators and Investigators

• Sponsor: Organon and Co

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2003
• Primary Completion (Actual): April 1, 2004
• Study Completion (Actual): April 1, 2004

Study Registration Dates

• First Submitted: October 30, 2008
• First Submitted That Met QC Criteria: February 2, 2009
• First Posted (Estimate): February 3, 2009

Study Record Updates

• Last Update Posted (Actual): February 17, 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: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Anti-Inflammatory Agents; Dermatologic Agents; Anti-Allergic Agents; Mometasone Furoate
• Other Study ID Numbers: P03270

Plan for Individual participant data (IPD)

Study Data/Documents

1. CSR Synopsis