Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg Once Daily (QD) in the Treatment of Seasonal Allergic Rhinitis (Study P05067)(COMPLETED)

NCT ID: NCT00453063

Last Updated: 2022-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 426 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2007-06-30

Brief Summary

This study is designed to assess the effectiveness of mometasone furoate nasal spay (MFNS) once daily (QD) compared with placebo in subjects with seasonal allergic rhinitis (SAR) in reducing the total nasal symptom score and the total ocular symptom score.

Conditions

Seasonal Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

MFNS 200 mcg QD

Group Type: EXPERIMENTAL

mometasone furoate

Intervention Type: DRUG

50 mcg/spray, two sprays in each nostril once daily (ie, 200 mcg QD) in the morning

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Two sprays in each nostril once daily in the morning

Interventions

mometasone furoate

50 mcg/spray, two sprays in each nostril once daily (ie, 200 mcg QD) in the morning

Intervention Type: DRUG

Placebo

Two sprays in each nostril once daily in the morning

Intervention Type: DRUG

Other Intervention Names

Nasonex; SCH 32088

Eligibility Criteria

Inclusion Criteria

• Must be 12 years of age or older, of either sex and of any race.
• Must have at least a 2-year documented history of SAR which exacerbates during the study season.
• Must have a positive skin-prick test response to an appropriate seasonal allergen at Screening (Visit 1). Immunoglobulin E (IgE)-mediated hypersensitivity to an appropriate seasonal allergen (ie, prevailing trees and/or grasses) must be documented by a positive response to the skin prick test with wheal diameter at least 3 mm larger than diluent control after 20 minutes.
• Must be clinically symptomatic at the Screening Visit.
• Must be clinically symptomatic at the Baseline Visit.
• Must be in general good health as confirmed by routine clinical and laboratory testing and electrocardiogram (ECG) results. Clinical laboratory test (complete blood count [CBC], blood chemistries, and urinalysis) must be within normal limits or clinically acceptable to the investigator and the sponsor.
• Must be free of any clinically significant disease, other than SAR, that would interfere with the study evaluations.

Exclusion Criteria

• A history of anaphylaxis and/or other severe local reaction(s) to skin testing.
• A subject with asthma who requires chronic use of inhaled or systemic corticosteroids.
• Current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip.
• A subject with rhinitis medicamentosa.
• A history of allergies to more than two classes of medications or who are allergic to or cannot tolerate nasal sprays.
• A subject who has had an upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or who has had a viral upper respiratory infection within 7 days before the Screening Visit.
• A subject who has nasal structural abnormalities, including large nasal polyps and marked septal deviations, which significantly interfere with nasal air flow.
• A subject who, in the opinion of the investigator, is dependent on nasal, oral, or ocular decongestants, nasal topical antihistamines, or nasal steroids.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Bielory L, Chun Y, Bielory BP, Canonica GW. Impact of mometasone furoate nasal spray on individual ocular symptoms of allergic rhinitis: a meta-analysis. Allergy. 2011 May;66(5):686-93. doi: 10.1111/j.1398-9995.2010.02543.x. Epub 2011 Jan 25.

Reference Type: RESULT

PMID: 21261661 (View on PubMed)

Other Identifiers

P05067

Identifier Type: -

Identifier Source: org_study_id