Perennial Allergic Rhinitis
Conditions
Keywords
TAU-284, Bepotastine besilate, Histamine H1 receptor antagonists, children
Brief summary
The objective of this study is to evaluate the long-term safety and efficacy of TAU-284 (Bepotastine besilate) in pediatric patients with perennial allergic rhinitis for 12 weeks administration.
Detailed description
This is a multicenter,open-label, single-arm, uncontrolled study to evaluate the safety and efficacy of TAU-284 (20 mg/day) in pediatric patients with perennial allergic rhinitis for 12 weeks administration.
Interventions
Two TAU-284 5mg tablets will be taken orally twice a day
Sponsors
Tanabe Pharma Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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 total score for the three major nasal symptoms \[sneezing, rhinorrhea, and nasal congestion\] of at least 3 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 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 |
|---|---|
| Number of Patients With Adverse Events and Adverse Drug Reactions | Up to Week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities) | baseline, Week2, Week4, Week6, Week8, Week10 and Week 12 | — |
| Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings) | Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12 | — |
| Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] at Week2, Week4, Week6, Week8, Week10, Week 12 and Final Evaluation Point. | Baseline, Week2, Week4, Week6, Week8, Week10, Week 12 and Final Evaluation Point （up to Week 12） | Total score for the three major nasal symptoms (sneezing, rhinorrhea, and nasal congestion) were rated on 5-point scale ranging from 0 (no symptom) to 4 (very severe). |
| Influence of Activities in Daily Life(Study, Outing, Sleeping) | Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12 | — |
| Patient Impression of Nasal Symptoms(Sneezing, Rhinorrhea, Nasal Congestion, Nasal Pruritus, Eye Pruritus and Eye Tearing) | Week 12 or suspension | — |
| Change From Baseline in Severity Score for Symptoms of Allergic Rhinitis | baseline, Week2, Week4, Week6, Week8, Week10 and Week 12 | — |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TAU-284 TAU-284 10mg twice daily for 12 weeks | 58 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | TAU-284 |
|---|---|
| Age, Continuous | 11.2 years STANDARD_DEVIATION 2.3 |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 31 / 58 |
| serious Total, serious adverse events | 0 / 58 |
Outcome results
Primary
Number of Patients With Adverse Events and Adverse Drug Reactions
Time frame: Up to Week 12
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAU-284 | Number of Patients With Adverse Events and Adverse Drug Reactions | Adverse events | 37 participants |
| TAU-284 | Number of Patients With Adverse Events and Adverse Drug Reactions | Adverse drug reactions | 2 participants |
Secondary
Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities)
Time frame: baseline, Week2, Week4, Week6, Week8, Week10 and Week 12
Secondary
Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)
Time frame: Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12
Secondary
Change From Baseline in Severity Score for Symptoms of Allergic Rhinitis
Time frame: baseline, Week2, Week4, Week6, Week8, Week10 and Week 12
Secondary
Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] at Week2, Week4, Week6, Week8, Week10, Week 12 and Final Evaluation Point.
Total score for the three major nasal symptoms (sneezing, rhinorrhea, and nasal congestion) were rated on 5-point scale ranging from 0 (no symptom) to 4 (very severe).
Time frame: Baseline, Week2, Week4, Week6, Week8, Week10, Week 12 and Final Evaluation Point （up to Week 12）
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| TAU-284 | Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] at Week2, Week4, Week6, Week8, Week10, Week 12 and Final Evaluation Point. | Week 2 | -0.943 units on a scale | Standard Deviation 1.549 |
| TAU-284 | Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] at Week2, Week4, Week6, Week8, Week10, Week 12 and Final Evaluation Point. | Week 4 | -1.388 units on a scale | Standard Deviation 1.465 |
| TAU-284 | Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] at Week2, Week4, Week6, Week8, Week10, Week 12 and Final Evaluation Point. | Week 6 | -1.321 units on a scale | Standard Deviation 1.844 |
| TAU-284 | Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] at Week2, Week4, Week6, Week8, Week10, Week 12 and Final Evaluation Point. | Week 8 | -1.433 units on a scale | Standard Deviation 1.88 |
| TAU-284 | Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] at Week2, Week4, Week6, Week8, Week10, Week 12 and Final Evaluation Point. | Week 10 | -1.460 units on a scale | Standard Deviation 1.777 |
| TAU-284 | Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] at Week2, Week4, Week6, Week8, Week10, Week 12 and Final Evaluation Point. | Week 12 | -1.451 units on a scale | Standard Deviation 1.707 |
| TAU-284 | Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] at Week2, Week4, Week6, Week8, Week10, Week 12 and Final Evaluation Point. | final evaluation point | -1.440 units on a scale | Standard Deviation 1.678 |
Secondary
Influence of Activities in Daily Life(Study, Outing, Sleeping)
Time frame: Second enrollment, Week2, Week4, Week6, Week8, Week10 and Week 12
Secondary
Patient Impression of Nasal Symptoms(Sneezing, Rhinorrhea, Nasal Congestion, Nasal Pruritus, Eye Pruritus and Eye Tearing)
Time frame: Week 12 or suspension