Rhinitis, Allergic, PerennialPhase 3NCT01165424
A Study of Long-term Administration of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Study P06333AM1)
A Phase 3 study testing mometasone furoate in people with Rhinitis, Allergic, Perennial, run by Organon and Co.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 15 years
- Conditions the study is for
- Rhinitis, Allergic, Perennial
- What is being tested?
- mometasone furoate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to Dec 2010
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
About this study
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)
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.
- Conditions
- Rhinitis, Allergic, Perennial
- Being tested
- mometasone furoate
- Medical subject headings
- Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mometasone furoateDrug
Also called Nasonex
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.
| Study group | Role | What they receive |
|---|---|---|
| MFNS 50 μg device | Experimental | 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. Receives: Drug: mometasone furoate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events and Adverse Drug Reactions
Measured: Baseline to Week 24
Secondary outcomes (1)
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.
Measured: Baseline and Weeks 2, 4, 8, 12, and 24 (or discontinuation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rhinitis, Allergic, PerennialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01165424
- Sponsor's protocol ID
- P06333
- Status last verified
- Feb 2022
- First submitted
- 28 May 2010
- Last updated
- 24 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No