Study of Nasonex in the Relief of Nasal Congestion in Patients With Seasonal Allergic Rhinitis (Study P05583)

• ClinicalTrials.gov Identifier: NCT00728416
• Recruitment Status: Completed
• First Posted: August 5, 2008
• Results First Posted: November 19, 2009
• Last Update Posted: February 9, 2022
• Sponsor: Organon and Co
• Information provided by (Responsible Party): Organon and Co

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Allergic Rhinitis	Drug: Mometasone furoate nasal spray (MFNS); Drug: Matching placebo nasal spray	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 333 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg QD in the Relief of Nasal Congestion Associated With Seasonal Allergic Rhinitis (SAR)
• Study Start Date: August 2008
• Actual Primary Completion Date: October 2008
• Actual Study Completion Date: October 2008

Arms and Interventions

Arm	Intervention/treatment
Experimental: Arm 1; Mometasone furoate nasal spray 200 mcg QD (once per day)	Drug: Mometasone furoate nasal spray (MFNS); MFNS 50 mcg/spray: two sprays in each nostril once daily (ie, 200 mcg QD) for 15 days; Other Name: MK-0887, Nasonex Nasal Spray
Placebo Comparator: Arm 2; Matching placebo nasal spray	Drug: Matching placebo nasal spray; Matching placebo nasal spray: 2 sprays in each nostril once daily for 15 days; Other Name: Placebo

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days [ Time Frame: 15 days of treatment ]
   Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. PRIOR (the subject's status over the previous 12 hours [reflective]). Baseline is the average score from the 3 days prior to the first dose of study drug.

Secondary Outcome Measures :

1. Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days [ Time Frame: 15 days of treatment ]
   Total nasal symptom score (TNSS) is a composite of 4 symptoms, each is scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total can range from 0 to 12. PRIOR (the subject's status over the previous 12 hours [reflective]). Baseline is the average score from the 3 days prior to the first dose of study drug.

Eligibility Criteria

• Ages Eligible for Study: 12 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Sponsors and Collaborators

Organon and Co

Investigators

• Study Director: Medical Director; Merck Sharp & Dohme LLC

More Information

Publications of Results:

Meltzer EO, Shekar T, Teper AA. Mometasone furoate nasal spray for moderate-to-severe nasal congestion in subjects with seasonal allergic rhinitis. Allergy Asthma Proc. 2011 Mar-Apr;32(2):159-67. doi: 10.2500/aap.2011.32.3424.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT00728416
• Other Study ID Numbers: P05583; MK-0887-160 ( Other Identifier: Merck )
• First Posted: August 5, 2008
• Results First Posted: November 19, 2009
• Last Update Posted: February 9, 2022
• Last Verified: February 2022

Additional relevant MeSH terms:

Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Mometasone Furoate; Anti-Inflammatory Agents; Dermatologic Agents; Anti-Allergic Agents