Rhinitis, Allergic, Perennial
Conditions
Brief 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 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.
Interventions
DRUGMometasone furoate
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
DRUGPlacebo
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
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Subjects for whom any of the main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Total Nasal Symptom Score at 2 Weeks | Baseline and 2 weeks (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, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Total Nasal Symptom Score at 1 Week | Baseline and 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MFNS Mometasone furoate nasal spray (MFNS) 50 mcg nasal spray device. The dose was as follows:
* 5 to 11 years: one spray per nostril once daily (100 mcg/day as MF) in the morning for 2 weeks.
* 12 to 15 years: 2 sprays per nostril once daily (200 mcg/day as MF) in the morning for 2 weeks. | 220 |
| Placebo Placebo MFNS. Administration was 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. | 113 |
| Total | 333 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Did not meet protocol eligibility | 1 | 0 |
Baseline characteristics
| Characteristic | MFNS | Placebo | Total |
|---|---|---|---|
| Age, Customized Between 12 and 15 years | 74 Participants | 39 Participants | 113 Participants |
| Age, Customized Between 5 and 11 years | 146 Participants | 74 Participants | 220 Participants |
| Sex: Female, Male Female | 90 Participants | 38 Participants | 128 Participants |
| Sex: Female, Male Male | 130 Participants | 75 Participants | 205 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 24 / 220 | 19 / 113 |
| serious Total, serious adverse events | 0 / 220 | 0 / 113 |
Outcome results
Primary
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.
Time frame: Baseline and 2 weeks (or discontinuation)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| MFNS | Change From Baseline in the Total Nasal Symptom Score at 2 Weeks | -3.9850 score on a scale | Standard Error 0.1633 |
| Placebo | Change From Baseline in the Total Nasal Symptom Score at 2 Weeks | -1.9081 score on a scale | Standard Error 0.2233 |
p-value: <0.0001ANCOVA
Secondary
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.
Time frame: Baseline and 1 week
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| MFNS | Change From Baseline in the Total Nasal Symptom Score at 1 Week | -2.4686 score on a scale | Standard Error 0.1441 |
| Placebo | Change From Baseline in the Total Nasal Symptom Score at 1 Week | -1.1651 score on a scale | Standard Error 0.1967 |
p-value: <0.0001ANCOVA