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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Rhinitis, Allergic

Intervention / Treatment
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* Drug: Mometasone furoate
* Drug: Mometasone furoate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mometasone furoate<br> | Drug: Mometasone furoate<br>* Mometasone furoate 200 mcg (2 puffs in each nostril) once a day for 28 days<br>* Other names: SCH 32088;|
| Experimental: Mometasone furoate plus an oral antihistamine<br> | Drug: Mometasone furoate<br>* 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<br>* Other names: SCH 32088;|

What is the study measuring?
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Primary Outcome Measures

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