Rhinitis, Allergic, Perennial
Conditions
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.
Interventions
DRUGmometasone furoate
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.
Sponsors
Organon and Co
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 15 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events and Adverse Drug Reactions | Baseline to Week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Total Nasal Symptom Score | Baseline and Weeks 2, 4, 8, 12, and 24 (or discontinuation) | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MFNS Mometasone furoate nasal spray (MFNS) 50 mcg device.
Participants aged 3 to 11 years received one spray per nostril once daily (100 mcg/day) in the morning for up to 24 weeks.
Participants aged 12 to 15 years received 2 sprays per nostril once daily (200 mcg/day) in the morning for up to 24 weeks. | 80 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Clinical adverse experiences | 1 |
| Overall Study | Did not meet entry criteria | 1 |
| Overall Study | Laboratory adverse experiences | 1 |
| Overall Study | Participant moved (relocated) | 1 |
Baseline characteristics
| Characteristic | MFNS |
|---|---|
| Age, Continuous | 9.2 years STANDARD_DEVIATION 3.4 |
| Region of Enrollment Japan | 80 Participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 72 / 80 |
| serious Total, serious adverse events | 1 / 80 |
Outcome results
Primary
Number of Participants With Adverse Events and Adverse Drug Reactions
Time frame: Baseline to Week 24
Population: All treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MFNS | Number of Participants With Adverse Events and Adverse Drug Reactions | Number with Adverse Events | 76 participants |
| MFNS | Number of Participants With Adverse Events and Adverse Drug Reactions | Number with Adverse Drug Reactions | 18 participants |
Secondary
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.
Time frame: Baseline and Weeks 2, 4, 8, 12, and 24 (or discontinuation)
Population: All treated participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MFNS | Change From Baseline in the Total Nasal Symptom Score | Change at Week 8 | -4.4 units on a scale | Standard Error 0.3 |
| MFNS | Change From Baseline in the Total Nasal Symptom Score | Change at Week 12 | -4.5 units on a scale | Standard Error 0.3 |
| MFNS | Change From Baseline in the Total Nasal Symptom Score | Change at Week 24 | -4.8 units on a scale | Standard Error 0.3 |
| MFNS | Change From Baseline in the Total Nasal Symptom Score | Change at Week 2 | -3.1 units on a scale | Standard Error 0.3 |
| MFNS | Change From Baseline in the Total Nasal Symptom Score | Change at Week 4 | -3.9 units on a scale | Standard Error 0.3 |