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

NCT00834119 | Completed Phase 4

• 1 other identifier: P03270
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

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, 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.

Conditions

Rhinitis, Allergic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Patient satisfaction with intranasal steroid monotherapy.

  Day 28

• Potential benefit of an oral antihistamine in combination with an intranasal steroid

  Day 56

Study Arms (2)

Mometasone furoate

EXPERIMENTAL

Drug: Mometasone furoate

Mometasone furoate plus an oral antihistamine

EXPERIMENTAL

Drug: Mometasone furoate

Interventions

Mometasone furoate DRUG

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

Also known as: Nasonex, SCH 32088

Mometasone furoate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Organon and Co: lead

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Mometasone Furoate

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2008
• First Posted: February 3, 2009
• Study Start: September 1, 2003
• Primary Completion: April 1, 2004
• Study Completion: April 1, 2004
• Last Updated: August 15, 2024

Record last verified: 2022-02