Study of Nasonex in the Relief of Nasal Congestion in Patients With Seasonal Allergic Rhinitis (Study P05528)(COMPLETED)

NCT ID: NCT00733005

Last Updated: 2024-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 324 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2008-10-31

Brief Summary

This study seeks to prospectively demonstrate that Nasonex is better than placebo in relieving nasal congestion in patients with seasonal allergic rhinitis.

Conditions

Allergic Rhinitis

Study Design

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

Study Groups

Arm 1

Mometasone furoate nasal spray 200 mcg QD (once per day)

Group Type: EXPERIMENTAL

Mometasone furoate nasal spray (MFNS)

Intervention Type: DRUG

MFNS 50 mcg/spray: two sprays in each nostril once daily (ie, 200 mcg QD) for 15 days

Arm 2

Matching placebo nasal spray

Group Type: PLACEBO_COMPARATOR

Matching placebo nasal spray

Intervention Type: DRUG

Matching placebo nasal spray: 2 sprays in each nostril once daily for 15 days

Interventions

Mometasone furoate nasal spray (MFNS)

MFNS 50 mcg/spray: two sprays in each nostril once daily (ie, 200 mcg QD) for 15 days

Intervention Type: DRUG

Matching placebo nasal spray

Matching placebo nasal spray: 2 sprays in each nostril once daily for 15 days

Intervention Type: DRUG

Other Intervention Names

Nasonex Nasal Spray; Placebo

Eligibility Criteria

Inclusion Criteria

• A subject must be 12 years of age or older, of either sex, and of any race.
• A subject must have at least a 2-year history of SAR which exacerbates during the study season.
• A subject must have a positive skin prick test response to an appropriate seasonal allergen at Visit 1.
• A subject must be clinically symptomatic at the Screening and Baseline Visits.

Exclusion Criteria

• A subject with a history of severe local reaction(s) or anaphylaxis to skin testing.
• 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 prior to the Screening Visit.
• A subject who has used any drug in an investigational protocol in the 30 days prior to the Screening Visit.
• A subject who is participating in any other clinical study.
• A subject who is part of the staff personnel directly involved with this study.
• A subject who is a family member (parent, spouse, or sibling) of the investigational study staff.
• A female subject who is breast-feeding, pregnant, or intends to become pregnant.
• A subject previously randomized into this study.
• A subject who has a family member (parent, spouse, or sibling) currently enrolled in this study.

• 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

Other Identifiers

P05528

Identifier Type: -

Identifier Source: org_study_id