Can this antihistamine tablet ease Kids' constant stuffy noses?
NCT ID NCT01861522
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether the drug TAU-284 (bepotastine besilate) can reduce sneezing, runny nose, and congestion in children aged 7 to 15 with perennial allergic rhinitis (year-round nasal allergies). In a double-blind, placebo-controlled design, 473 children took either the drug or a placebo twice daily for two weeks. The goal was to confirm the drug's superiority over placebo and check its safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- bepotastine besilate (antihistamine tablet)
- What this could lead to
- If it works, this could provide a proven option to ease sneezing, runny nose, and congestion in children with year-round allergies.
- What could go wrong
- This is a completed Phase 3 trial, but results may not show a big enough benefit over placebo. Also, the drug is already approved in some forms, so this is confirmatory, not a breakthrough.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
473 people
The number who actually took part.
- Start date
-
Apr 2013
- Finished
-
Dec 2013
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
7 to 15 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Reserch site
Fukuoka, Japan
-
Reserch site
Toyama, Japan
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Other studies related to the condition(s) this trial covers.
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