A Study of Epinastine Nasal Spray in Subjects With Seasonal Allergic Rhinitis

A Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Safety, Efficacy, and Tolerability Study of Two Doses of Epinastine Nasal Spray (0.05% and 0.1%) vs. Placebo in Subjects With Seasonal Allergic Rhinitis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00407927

Enrollment

571

Registered

2006-12-05

Start date

2006-12-31

Completion date

2007-03-31

Last updated

2015-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seasonal Allergic Rhinitis

Brief summary

The purpose of this trial is to determine the safety, efficacy and tolerability of two doses of the study drug compared to placebo for the treatment of subjects with seasonal allergic rhinitis.

Interventions

DRUGEpinastine Nasal Spray

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Inclusion criteria

* A documented history of seasonal allergic rhinitis to mountain cedar pollen

Exclusion criteria

* Significant medical condition * Cardiovascular abnormality * Have a significant physical obstruction in the nose * Started or had a change in immunotherapy within the 30 days prior to screening * Have nasal ulceration(s) or any active nasal bleeding * Require use of allergy medications during the study * Require use of asthma medications other than as needed albuterol

Design outcomes

Primary

Measure	Time frame
Change in nasal symptom scores	—

Secondary

Measure	Time frame
Change in non-nasal symptom scores and quality of life scores	—
Standard safety assessments	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026