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

Rhinitis, Allergic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00834119
• Other study ID #: P03270
• Status: Completed
• Phase: Phase 4
• Start date: September 1, 2003
• Est. completion date: April 1, 2004

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: April 1, 2004
• Est. primary completion date: April 1, 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• Mometasone furoate
Mometasone furoate 200 mcg (2 puffs in each nostril) once a day for 28 days
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient satisfaction with intranasal steroid monotherapy.		Day 28
Secondary	Potential benefit of an oral antihistamine in combination with an intranasal steroid		Day 56