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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mometasone furoate

Drug

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

Other names: Nasonex, SCH 32088

Primary outcomes

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.

Time frame: Day 28 and Day 56

Secondary outcomes

Patient satisfaction with intranasal steroid monotherapy.

Time frame: Day 28
Potential benefit of an oral antihistamine in combination with an intranasal steroid

Time frame: Day 56

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study 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

Important dates

Study start: 2003
Primary completion: 2004
Study completion: 2004
First posted: Feb 3, 2009
Registry last updated: Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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