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

NCT00733005 | Completed Phase 3 Results

• 1 other identifier: P05528
• Study Type: interventional
• Target: 324
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• The Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days.

  Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. PRIOR (the subject's status over the previous 12 hours \[reflective\])

  15 days of treatment

Secondary Outcomes (1)

• The Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days

  15 days of treatment

Study Arms (2)

Arm 1

EXPERIMENTAL

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

Drug: Mometasone furoate nasal spray (MFNS)

Arm 2

PLACEBO COMPARATOR

Matching placebo nasal spray

Drug: Matching placebo nasal spray

Interventions

Mometasone furoate nasal spray (MFNS) DRUG

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

Also known as: Nasonex Nasal Spray

Arm 1

Matching placebo nasal spray DRUG

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

Also known as: Placebo

Arm 2

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

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

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck, Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2008
• First Posted: August 12, 2008
• Study Start: July 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: May 21, 2024
• Results First Posted: November 19, 2009

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share