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

This study has been completed.

Sponsored by:	Inspire Pharmaceuticals
Information provided by:	Inspire Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00407927

Purpose

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.

Condition	Intervention	Phase
Seasonal Allergic Rhinitis	Drug: Epinastine Nasal Spray	Phase II

MedlinePlus related topics: Hay Fever

Drug Information available for: Epinastine Epinastine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:	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

Further study details as provided by Inspire Pharmaceuticals:

Primary Outcome Measures:

Change in nasal symptom scores

Secondary Outcome Measures:

Change in non-nasal symptom scores and quality of life scores
Standard safety assessments

Estimated Enrollment:	580
Study Start Date:	December 2006

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00407927

Locations

United States, Texas
Allergy & Asthma Associates
Austin, Texas, United States, 78731
Lovelace Scientific Resources, Inc.
Austin, Texas, United States, 78759
Biogenics Research Institute
San Antonio, Texas, United States, 78229
Sylvana Research Associates
San Antonio, Texas, United States, 78229
Allergy Asthma Research Institute
Waco, Texas, United States, 76712
Central Texas Health Research
New Braunfels, Texas, United States, 78130
Kerrville Research Associates
Kerrville, Texas, United States, 78028

Sponsors and Collaborators

Inspire Pharmaceuticals

More Information

Study ID Numbers:	033-101
Study First Received:	December 4, 2006
Last Updated:	May 29, 2007
ClinicalTrials.gov Identifier:	NCT00407927
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Hypersensitivity
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Rhinitis, Allergic, Seasonal
Hypersensitivity, Immediate

Histamine phosphate
Rhinitis
Histamine
Epinastine
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Histamine Antagonists
Immune System Diseases
Physiological Effects of Drugs

Histamine Agents
Histamine H1 Antagonists
Pharmacologic Actions
Nose Diseases

ClinicalTrials.gov processed this record on January 16, 2009