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

Merck Sharp & Dohme LLC571 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

571

Conditions

Seasonal Allergic Rhinitis

Interventions

Epinastine Nasal SprayDRUG

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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

Locations (7)

Allergy & Asthma Associates

Austin, Texas, United States

Lovelace Scientific Resources, Inc.

Austin, Texas, United States

Kerrville Research Associates

Kerrville, Texas, United States

Central Texas Health Research

New Braunfels, Texas, United States

Outcomes

Primary Outcomes

Change in nasal symptom scores

Secondary Outcomes

Change in non-nasal symptom scores and quality of life scores

Standard safety assessments

Data from ClinicalTrials.gov

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