Safety and Efficacy Study of Epinastine Nasal Spray in Subjects With Seasonal Allergic Rhinitis - Full Text View

Sponsored by:	Inspire Pharmaceuticals
Information provided by:	Inspire Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00564421

Purpose

The purpose of this study is to determine the safety and efficacy of epinastine nasal spray compared to placebo for the treatment of subjects with seasonal allergic rhinitis

Condition	Intervention	Phase
Seasonal Allergic Rhinitis	Drug: epinastine nasal spray, low concentration, low dose volume Drug: placebo nasal spray Drug: epinastine nasal spray, low concentration, high dose volume Drug: epinastine nasal spray, high concentration, low dose volume Drug: epinastine nasal spray, high concentration, high dose volume	Phase III

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 (Subject, Investigator), Placebo Control, Parallel Assignment
Official Title:	A Phase 3 Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple Dose Safety and Efficacy Study of Epinastine Nasal Spray vs. Placebo in Subjects With Seasonal Allergic Rhinitis

Further study details as provided by Inspire Pharmaceuticals:

Primary Outcome Measures:

Change in nasal symptom scores [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in ocular symptom scores and quality of life scores [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Standard safety assessments [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Enrollment:	798
Study Start Date:	November 2007
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: epinastine nasal spray, low concentration, low dose volume 2 sprays in each nostril, dosed twice a day
2: Experimental	Drug: epinastine nasal spray, low concentration, high dose volume 2 sprays in each nostril, dosed twice a day
3: Experimental	Drug: epinastine nasal spray, high concentration, low dose volume 2 sprays in each nostril, dosed twice a day
4: Experimental	Drug: epinastine nasal spray, high concentration, high dose volume 2 sprays in each nostril, dosed twice a day
5: Placebo Comparator	Drug: placebo nasal spray 2 sprays in each nostril, dosed twice a day

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

A documented history of seasonal allergic rhinitis to mountain cedar or other spring pollen

Exclusion Criteria:

Significant medical condition
Significant nasal abnormality
Significant cardiac condition
Recent infection
Use of other allergy medication during the study
Use of asthma medication other than as-needed albuterol

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00564421

Locations

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

Sponsors and Collaborators

Inspire Pharmaceuticals

Investigators

Study Director:

Donald Kellerman, PharmD

Inspire Pharmaceuticals

More Information

Responsible Party:	Inspire Pharmaceuticals ( Amy Schaberg, BSN, Vice President Respiratory Clinical Research )
Study ID Numbers:	033-103
Study First Received:	November 27, 2007
Last Updated:	May 1, 2008
ClinicalTrials.gov Identifier:	NCT00564421
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 15, 2009