Perennial Allergic Rhinitis
Conditions
Keywords
TAU-284, Bepotastine besilate, Histamine H1 receptor antagonists
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 the dose response, safety, and plasma concentrations of TAU-284.
Detailed description
This is a randomized, double-blind, placebo-controlled, 3-arm parallel-group comparative study to confirm the superiority of TAU-284 over placebo after two weeks of administration of TAU-284 (10 mg/day or 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 the dose response, safety, and plasma concentrations of TAU-284.
Interventions
DRUGTAU-284
TAU-284 Low
DRUGPlacebo
Placebo
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 with a weight of at least 20 kg * Patients who have received a diagnosis of perennial allergic rhinitis according to the diagnostic criteria * Patients with a mean rhinorrhea score of at least 2 and a mean total score for the three major nasal symptoms \[sneezing, rhinorrhea, and nasal congestion\] of at least 4 on the basis of symptoms recorded in the nasal allergy diary during the observation period
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 * Patients with current or previous history of drug allergy * Patients who concurrently have renal function abnormalities that may cause safety problems
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] (at Final Evaluation) | Baseline and Week 2 | Total score for the three major nasal symptoms (sneezing, rhinorrhea, and nasal congestion) were rated on 4-point scale ranging from 0 (no symptoms) to 3 (severe) . |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline in Individual Nasal Symptom Scores (Sneezing, Rhinorrhea, Nasal Congestion, and Impairment in Daily Activities) | Week 2 |
| Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings) | Week 2 |
| Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] | Week 2 |
| Adverse Events and Adverse Drug Reactions | Week 2 |
| Plasma Concentrations of Unchanged TAU-284 (Bepotastine Besilate) (at a Total of 3 Time Points, i.e., Before and 2 (±1) Hours After Study-drug Administration at Week 1 and Before Study-drug Administration at Week 2) | Week 2 |
| Change From Baseline in Severity Score | Week 2 |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TAU-284 Low TAU-284 5mg twice daily for 2 weeks | 161 |
| TAU-284 High TAU-284 10mg twice daily for 2 weeks | 166 |
| Placebo TAU-284 placebo twice daily for 2 weeks | 163 |
| Total | 490 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 1 |
| Overall Study | Physician Decision | 1 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | TAU-284 Low | TAU-284 High | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 11.2 years STANDARD_DEVIATION 2.5 | 11.4 years STANDARD_DEVIATION 2.3 | 11.2 years STANDARD_DEVIATION 2.5 | 11.2 years STANDARD_DEVIATION 2.4 |
| Sex: Female, Male Female | 62 Participants | 64 Participants | 72 Participants | 198 Participants |
| Sex: Female, Male Male | 99 Participants | 102 Participants | 91 Participants | 292 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 17 / 161 | 8 / 166 | 15 / 163 |
| serious Total, serious adverse events | 0 / 161 | 0 / 166 | 0 / 163 |
Outcome results
Primary
Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] (at Final Evaluation)
Total score for the three major nasal symptoms (sneezing, rhinorrhea, and nasal congestion) were rated on 4-point scale ranging from 0 (no symptoms) to 3 (severe) .
Time frame: Baseline and Week 2
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| TAU-284 Low | Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] (at Final Evaluation) | -0.84 units on a scale | Standard Error 0.12 |
| TAU-284 High | Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] (at Final Evaluation) | -0.92 units on a scale | Standard Error 0.12 |
| Placebo | Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion] (at Final Evaluation) | -0.70 units on a scale | Standard Error 0.12 |
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: Week 2
Secondary
Change From Baseline in Individual Scores for Local Nasal Findings (Rhinoscopic Findings)
Time frame: Week 2
Secondary
Change From Baseline in Severity Score
Time frame: Week 2
Secondary
Change From Baseline in Total Score for the Three Major Nasal Symptoms [Sneezing, Rhinorrhea, and Nasal Congestion]
Time frame: Week 2
Secondary
Plasma Concentrations of Unchanged TAU-284 (Bepotastine Besilate) (at a Total of 3 Time Points, i.e., Before and 2 (±1) Hours After Study-drug Administration at Week 1 and Before Study-drug Administration at Week 2)
Time frame: Week 2