Status:
COMPLETED
Assessment of Intranasal Steroids in Allergic Rhinitis When Used Alone or in Combination With an Oral Antihistamine (Study P03270)
Lead Sponsor:
Organon and Co
Conditions:
Rhinitis, Allergic
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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, whe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2004
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00834119
Start Date
September 1 2003
End Date
April 1 2004
Last Update
August 15 2024
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