Perennial Allergic Rhinitis
Conditions
Keywords
TAU-284, Bepotastine besilate, Histamine H1 receptor antagonists, children
Brief summary
The objectives of this study are: to confirm the superiority of TAU-284 over placebo after two weeks of administration to pediatric patients with perennial allergic rhinitis and to investigate safety of TAU-284.
Detailed description
This is a randomized, double-blind, placebo-controlled, 2-arm parallel-group comparative study to confirm the superiority of TAU-284 over placebo after two weeks of administration of TAU-284 (20 mg/day) or placebo to pediatric patients with perennial allergic rhinitis, with the change from baseline in total nasal symptom score (total score for the three major nasal symptoms \[sneezing, rhinorrhea, and nasal congestion\]) as the primary endpoint; and to investigate safety of TAU-284.
Interventions
Two TAU-284 5mg tablets will be taken orally twice a day
DRUGPlacebo
Two Placebo tablets will be taken orally twice a day
Sponsors
Tanabe Pharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
7 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged between 7 and 15 years * Patients who have received a diagnosis of perennial allergic rhinitis according to the diagnostic criteria * Patients with a mean rhinorrhea score and a mean sneezing score of at least 2 on the basis of symptoms recorded in the nasal allergy diary during the observation period etc.
Exclusion criteria
* Patients with vasomotor rhinitis or eosinophilic rhinitis * Patients who have concurrent nasal disease that may affect the efficacy of TAU-284 * Patients with a history of any of the nasal surgical procedures * Patients who have a positive result for pollen antigens which are dispersed during the study period * Patients who have a positive result for dog dander or cat dander antigen and have a chance to touch dogs or cats. * Patients with current or previous history of drug allergy * Patients who concurrently have renal function abnormalities that may cause safety problems etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] | Baseline and Week 2 | Total score for the three major nasal symptoms (sneezing, rhinorrhea, and nasal congestion) were rated on 5-point scale ranging from 0 (no symptoms) to 4 (very severe). |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] | baseline, Week1 and Week 2 |
| Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities) | baseline, Week1 and Week 2 |
| Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings) | baseline, Week1 and Week 2 |
| Change From Baseline in Severity Score for Symptoms of Allergic Rhinitis | Randomization, Week1 and Week 2 |
| Adverse Events and Adverse Drug Reactions | Week 2 |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TAU-284 TAU-284 10mg twice daily for 2 weeks | 240 |
| Placebo TAU-284 placebo twice daily for 2 weeks | 232 |
| Total | 472 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | TAU-284 | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 10.3 years STANDARD_DEVIATION 2.4 | 10.4 years STANDARD_DEVIATION 2.4 | 10.4 years STANDARD_DEVIATION 2.4 |
| Sex: Female, Male Female | 108 Participants | 92 Participants | 200 Participants |
| Sex: Female, Male Male | 132 Participants | 140 Participants | 272 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 17 / 240 | 15 / 232 |
| serious Total, serious adverse events | 0 / 240 | 0 / 232 |
Outcome results
Primary
Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion]
Total score for the three major nasal symptoms (sneezing, rhinorrhea, and nasal congestion) were rated on 5-point scale ranging from 0 (no symptoms) to 4 (very severe).
Time frame: Baseline and Week 2
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| TAU-284 | Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] | -1.579 units on a scale | Standard Error 0.09 |
| Placebo | Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] | -1.110 units on a scale | Standard Error 0.092 |
Secondary
Adverse Events and Adverse Drug Reactions
Time frame: Week 2
Secondary
Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities)
Time frame: baseline, Week1 and Week 2
Secondary
Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)
Time frame: baseline, Week1 and Week 2
Secondary
Change From Baseline in Severity Score for Symptoms of Allergic Rhinitis
Time frame: Randomization, Week1 and Week 2
Secondary
Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion]
Time frame: baseline, Week1 and Week 2