Back to resultsA Study of Long-term Administration of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Study P06333AM1)
Primary Purpose
Rhinitis, Allergic, Perennial
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
mometasone furoate
Sponsored by
About this trial
This is an interventional treatment trial for Rhinitis, Allergic, Perennial
Eligibility Criteria
Inclusion Criteria:
- Subjects having symptoms of perennial allergic rhinitis of moderate to severe degree.
- Subjects confirmed to be allergic to non-seasonal environmental antigens (e.g., house dust mite antigen).
- Male or female outpatients aged 3 to 15 years at the time of providing informed consent.
Exclusion Criteria:
- Subjects with coexisting tuberculosis or lower respiratory tract infection, or who have an acute upper respiratory tract infection or acute pharyngolaryngitis, etc. judged by the investigator to require treatment at the time of registration
- Subjects with coexisting infections or systemic mycosis for which there are no effective antibiotics
- Subjects with repeated epistaxis
- Subjects with coexisting fungal infection in nasal/sinus cavity
- Subjects with a history of hypersensitivity to steroids or ingredients of mometasone furoate nasal spray
- Subjects with severe hepatic, renal, cardiac, hematological disease, diabetes mellitus, hypertension, or other serious coexisting diseases and whose general condition is poor.
- Subjects allergic to pollen (cedar, Japanese cypress, birch, grasses, mugwort, common ragweed, etc.) for whom the pollen season coincides with the observation period
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MFNS 50 μg device
Arm Description
MFNS 50 μg spray device. The dose will be as follows: 3 to 11 years: one spray per nostril once daily (100 μg/day) in the morning. 12 to 15 years: 2 sprays per nostril once daily (200 μg/day) in the morning.
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events and Adverse Drug Reactions
Secondary Outcome Measures
Change From Baseline in the Total Nasal Symptom Score
Total nasal symptom score was a composite of 4 symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching). Each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe for a total score ranging from 0 to 12. A higher score indicates more severe symptoms.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01165424
Brief Title
A Study of Long-term Administration of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Study P06333AM1)
Official Title
A Study of Long-term (12-24 Weeks) Administration of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Protocol No. P06333)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (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
Mometasone furoate nasal spray (MFNS) is a once-a-day product. This is a multi-center, open-label study of MFNS in children with perennial allergic rhinitis. MFNS will be administered to pediatric subjects (3-15 years old) with perennial allergic rhinitis at a dose of 100 to 200 μg/day (once daily) for 12 weeks. Subjects (subject's legal representatives) provided consent to continue treatment beyond 12 weeks will receive treatment for up to 24 weeks. At each clinic visit, observation of adverse events, nasal symptom scores, and nasal findings will be evaluated. The presence/absence of serious adverse events and trial procedure-related AEs will be reviewed 30 days after the end of the follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis, Allergic, Perennial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MFNS 50 μg device
Arm Type
Experimental
Arm Description
MFNS 50 μg spray device. The dose will be as follows:
3 to 11 years: one spray per nostril once daily (100 μg/day) in the morning.
12 to 15 years: 2 sprays per nostril once daily (200 μg/day) in the morning.
Intervention Type
Drug
Intervention Name(s)
mometasone furoate
Other Intervention Name(s)
Nasonex
Intervention Description
MFNS 50 μg spray device
3 to 11 years: one spray per nostril once daily (100 μg/day) in the morning.
12 to 15 years: 2 sprays per nostril once daily (200 μg/day) in the morning.
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events and Adverse Drug Reactions
Time Frame
Baseline to Week 24
Secondary Outcome Measure Information:
Title
Change From Baseline in the Total Nasal Symptom Score
Description
Total nasal symptom score was a composite of 4 symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching). Each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe for a total score ranging from 0 to 12. A higher score indicates more severe symptoms.
Time Frame
Baseline and Weeks 2, 4, 8, 12, and 24 (or discontinuation)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects having symptoms of perennial allergic rhinitis of moderate to severe degree.
Subjects confirmed to be allergic to non-seasonal environmental antigens (e.g., house dust mite antigen).
Male or female outpatients aged 3 to 15 years at the time of providing informed consent.
Exclusion Criteria:
Subjects with coexisting tuberculosis or lower respiratory tract infection, or who have an acute upper respiratory tract infection or acute pharyngolaryngitis, etc. judged by the investigator to require treatment at the time of registration
Subjects with coexisting infections or systemic mycosis for which there are no effective antibiotics
Subjects with repeated epistaxis
Subjects with coexisting fungal infection in nasal/sinus cavity
Subjects with a history of hypersensitivity to steroids or ingredients of mometasone furoate nasal spray
Subjects with severe hepatic, renal, cardiac, hematological disease, diabetes mellitus, hypertension, or other serious coexisting diseases and whose general condition is poor.
Subjects allergic to pollen (cedar, Japanese cypress, birch, grasses, mugwort, common ragweed, etc.) for whom the pollen season coincides with the observation period
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
Learn more about this trial
A Study of Long-term Administration of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Study P06333AM1)
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