Back to resultsStudy of Nasonex in the Relief of Nasal Congestion in Patients With Seasonal Allergic Rhinitis (Study P05583)
Primary Purpose
Allergic Rhinitis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Mometasone furoate nasal spray (MFNS)
Matching placebo nasal spray
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Rhinitis
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Arm 1
Arm 2
Arm Description
Mometasone furoate nasal spray 200 mcg QD (once per day)
Matching placebo nasal spray
Outcomes
Primary Outcome Measures
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, 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
Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00728416
Brief Title
Study of Nasonex in the Relief of Nasal Congestion in Patients With Seasonal Allergic Rhinitis (Study P05583)
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 Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
333 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Mometasone furoate nasal spray 200 mcg QD (once per day)
Arm Title
Arm 2
Arm Type
Placebo Comparator
Arm Description
Matching placebo nasal spray
Intervention Type
Drug
Intervention Name(s)
Mometasone furoate nasal spray (MFNS)
Other Intervention Name(s)
MK-0887, Nasonex Nasal Spray
Intervention Description
MFNS 50 mcg/spray: two sprays in each nostril once daily (ie, 200 mcg QD) for 15 days
Intervention Type
Drug
Intervention Name(s)
Matching placebo nasal spray
Other Intervention Name(s)
Placebo
Intervention Description
Matching placebo nasal spray: 2 sprays in each nostril once daily for 15 days
Primary Outcome Measure Information:
Title
Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days
Description
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.
Time Frame
15 days of treatment
Secondary Outcome Measure Information:
Title
Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days
Description
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.
Time Frame
15 days of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
21439168
Citation
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.
Results Reference
result
Learn more about this trial
Study of Nasonex in the Relief of Nasal Congestion in Patients With Seasonal Allergic Rhinitis (Study P05583)
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