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

Organon

Status and phase

Completed

Phase 4

Conditions

Rhinitis, Allergic

Treatments

Drug: Mometasone furoate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00834119

P03270

Details and patient eligibility

About

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.

Enrollment

72 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.