Rhinitis, Allergic, PerennialPhase 3NCT01135134
Multicenter, Double-blind, Randomized, Placebo-controlled Study of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Study P06332)
A Phase 3 study testing Mometasone furoate in people with Rhinitis, Allergic, Perennial, run by Organon and Co.
Trial summary
This is a multicenter, randomized, parallel design, double-blind study of mometasone furoate (MF) in pediatric subjects with perennial allergic rhinitis. The subjects 5 to 15 years of age with perennial allergic rhinitis will enter a no-treatment observation period of 7 days at minimum and eligibility for inclusion in… Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Rhinitis, Allergic, Perennial
- What is being tested?
- Mometasone furoate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 333 participants
- Where
- No sites listed yet
- Study dates
- Jun 2010to Oct 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 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric subjects with perennial allergic rhinitis who satisfy all of the following main criteria:
- Subjects having symptoms of perennial allergic rhinitis of moderate to severe degree, after the pretreatment observation period.
- Subjects confirmed to be allergic to non-seasonal environmental antigens (e.g., house dust-mite antigen).
- Male or female outpatients aged 5 to 15 years at the time of providing informed consent.
Who cannot join
- Subjects for whom any of the main exclusion criteria below is applicable will not be registered in this study.
- Subjects with coexisting tuberculous disease or lower respiratory tract infection and subjects who have a nasopharyngolaryngeal infection (acute upper respiratory tract infection, acute pharyngolaryngitis, or acute tonsillitis, etc.) requiring 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 who have nasal septum ulcers, nasal surgery, or nasal trauma, which have not healed
- Subjects with severe hepatic, renal, cardiac, hematological disease, diabetes mellitus, hypertension, or other serious coexisting diseases and whose general condition is poor
- Subjects with complication of vasomotor rhinitis or eosinophilic rhinitis.
- Subjects with nasal conditions (infectious sinusitis, hypertrophic rhinitis, acute or chronic rhinitis, nasal polyps, septal deviation, etc.) which may interfere with the evaluation of the efficacy of the study drug.
About this study
Official title: Multicenter, Double-blind, Randomized, Placebo-controlled Study of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Protocol No.P06332)
This is a multicenter, randomized, parallel design, double-blind study of mometasone furoate (MF) in pediatric subjects with perennial allergic rhinitis. The subjects 5 to 15 years of age with perennial allergic rhinitis will enter a no-treatment observation period of 7 days at minimum and eligibility for inclusion in this study will be assessed. Following the observation period, eligible subjects will be randomized to MF or MF placebo for a 2-week double-blind treatment. At each clinic visit (at the start of treatment and after 1 and 2 weeks of treatment or at discontinuation), nasal symptom scores, nasal findings, and adverse events (AEs), will be evaluated. A 30-day follow-up visit will take place after the completion (or discontinuation) of the 2-week treatment period, to confirm presence or absence of serious adverse events (SAEs) and trial procedure-related AEs.
- Conditions
- Rhinitis, Allergic, Perennial
- Being tested
- Mometasone furoate, Placebo
- 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
The study drug is MFNS (50 μg spray device) and the dose will be:
- 5 to 11 years: one spray per nostril once daily (100 μg/day as MF) in the morning for 2 weeks
- 12 to 15 years: 2 sprays per nostril once daily (200 μg/day as MF) in the morning for 2 weeks
PlaceboDrug
MF Placebo nasal spray and administration will be as follows:
- 5 to 11 years: one spray per nostril once daily in the morning for 2 weeks
- 12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Mometasone furoate nasal spray (MFNS) (50 μg spray device) | Experimental | The dose will be as follows:
* 5 to 11 years: one spray per nostril once daily (100 μg/day as MF) in the morning for 2 weeks
* 12 to 15 years: 2 sprays per nostril once daily (200 μg/day as MF) in the morning for 2 weeks Receives: Drug: Mometasone furoate |
| MF placebo nasal spray | Placebo comparator | Administration will be as follows:
* 5 to 11 years: one spray per nostril once daily in the morning for 2 weeks
* 12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Total Nasal Symptom Score at 2 Weeks
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, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were.
Measured: Baseline and 2 weeks (or discontinuation)
Secondary outcomes (1)
Change From Baseline in the Total Nasal Symptom Score at 1 Week
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, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were.
Measured: Baseline and 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionOct 2010
- Study completionOct 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 333 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
- NCT01135134
- Sponsor's protocol ID
- P06332
- Status last verified
- Feb 2022
- First submitted
- 28 May 2010
- Last updated
- 28 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Okamoto Y, Suzuki I . Multicenter, double-blind, randomized, placebo-controlled study of mometasone furoate nasal spray in Japanese pediatric subjects with perennial allergic rhinitis . Oto-rhino Laryngol Tokyo. 2013;106(11):1045-1057.