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Phenylephrine Nasal

4-Way Fast Acting; Afrin Children's Pump Mist; Ah-chew D; Little Colds; Little Noses Gentle Formula

Clinical Trial: Study of Adults and Adolescents with Vasomotor/Idiopathic Rhinitis

This study is not yet open for patient recruitment.

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline

Purpose

The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with vasomotor rhinitis (VMR).

Condition	Intervention	Phase
Vasomotor Rhinitis	Drug: Intranasal GW685698X Aqueous Nasal Spray	Phase III

MedlinePlus related topics: Nose Disorders

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 4 Weeks in Adult and Adolescent Subjects (12 Years of Age and Older) with Vasomotor Rhinitis

Further Study Details:

Primary Outcomes: Mean change from baseline in daily, reflective total nasal symptom scores.
Secondary Outcomes: Mean change from baseline in AM, pre-dose, instantaneous total nasal symptom scores.; Overall evaluation of response to therapy.
Expected Total Enrollment: 350

Study start: July 2005

Eligibility

Ages Eligible for Study: 12 Years and above, Genders Eligible for Study: Both

Criteria

Inclusion criteria:

Must be outpatients.
Diagnosis of VMR.
Literate in English or native language.

Exclusion criteria:

Have a significant concomitant medical condition.
Use corticosteroids or other allergy medications during the study.
Have used tobacco products within the past year.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier NCT00117325

California
Stuart Epstein, Beverly Hills, California, 90212, United States

Stuart Epstein 310-274-6853
Stuart Epstein, Principal Investigator

Bruce Prenner, San Diego, California, 92120, United States

Bruce Prenner 619-229-2355
Bruce Prenner, Principal Investigator

Eli Meltzer, San Diego, California, 92123, United States

Eli Meltzer 858-268-2368
Eli Meltzer, Principal Investigator

Steven Weinstein, Huntington Beach, California, 92647, United States

Steven Weinstein 714-848-8585 Ext. 18
Steven Weinstein, Principal Investigator

Colorado
David Pearlman, Denver, Colorado, 80230, United States

David Pearlman 518-262-5897
David Pearlman, Principal Investigator

Janet Seeley, Loveland, Colorado, 80538, United States

Janet Seeley 970-667-6460
Janet Seeley, Principal Investigator

Robert Nathan, Colorado Springs, Colorado, 80907, United States

Robert Nathan 719-473-8330 Ext. 152
Robert Nathan, Principal Investigator

Georgia
Robert Berkowitz, Woodstock, Georgia, 30188, United States

Robert Berkowitz 770-592-4210
Robert Berkowitz, Principal Investigator

Illinois
Robert Naclerio, Chicago, Illinois, 60637, United States

Robert Naclerio 773-702-5889
Robert Naclerio, Principal Investigator

Indiana
John Beman, Evansville, Indiana, 47713, United States

John Beman 812-426-9731
John Beman, Principal Investigator

Louisiana
Richard Guillot, Covington, Louisiana, 70433, United States

Richard Guillot 985-893-5780
Richard Guillot, Principal Investigator

Maine
Jonathan Musmand, Portland, Maine, 04102, United States

Jonathan Musmand 207-774-9839 Ext. 204
Jonathan Musmand, Principal Investigator

Paul Shapero, Bangor, Maine, 04401, United States

Paul Shapero 207-947-8658
Paul Shapero, Principal Investigator

Maryland
Kathy Lampl, Rockville, Maryland, 20850, United States

Kathy Lampl 301-340-7412 Ext. 28
Kathy Lampl, Principal Investigator

Johnathan Matz, Baltimore, Maryland, 21236, United States

Johnathan Matz 410-931-0404 Ext. 111
Johnathan Matz, Principal Investigator

Michigan
Michael Rowe, Novi, Michigan, 48375, United States

Michael Rowe 248-473-6400
Michael Rowe, Principal Investigator

Minnesota
Harold Kaiser, Minneapolis, Minnesota, 55402, United States

Harold Kaiser 612-333-2200 Ext. 1360
Harold Kaiser, Principal Investigator

New Jersey
Marc Goldstein, Mt. Laurel, New Jersey, 08054, United States

Marc Goldstein 856-235-8282
Marc Goldstein, Principal Investigator

Richard Sterling, Orangeburg, New Jersey, 29118, United States

Richard Sterling 803-534-3324
Richard Sterling, Principal Investigator

New York
Juan Sotomayor, Liverpool, New York, 13088, United States

Juan Sotomayor 315-452-2966
Juan Sotomayor, Principal Investigator

John Condemi, Rochester, New York, 14618, United States

John Condemi 585-442-1980
John Condemi, Principal Investigator

Ohio
Mark Mehle, North Olmsted, Ohio, 44070, United States

Mark Mehle 440-779-1112
Mark Mehle, Principal Investigator

John Given, Canton, Ohio, 44718, United States

John Given 330-479-3333
John Given, Principal Investigator

Pennsylvania
Berrylin Ferguson, Pittsburgh, Pennsylvania, 15213, United States

Berrylin Ferguson 412-647-4654
Berrylin Ferguson, Principal Investigator

John Fornadley, Palmyra, Pennsylvania, 17078, United States

John Fornadley 717-832-0500
John Fornadley, Principal Investigator

Eric Schenkel, Easton, Pennsylvania, 18045, United States

Eric Schenkel 610-252-7388 Ext. 506
Eric Schenkel, Principal Investigator

South Carolina
Albert Finn, Charleston, South Carolina, 29406, United States

Albert Finn 843-820-1036
Albert Finn, Principal Investigator

Allen Kaplan, Charleston, South Carolina, 29407, United States

Allen Kaplan 843-852-4852
Allen Kaplan, Principal Investigator

Tennessee
David Gossage, Knoxville, Tennessee, 37922, United States

David Gossage 985-893-5780
David Gossage, Principal Investigator

Phillip Lieberman, Germantown, Tennessee, 38138, United States

Phillip Lieberman 901-757-6100 Ext. 239
Phillip Lieberman, Principal Investigator

Czech Republic
GSK Clinical Trials Call Center, Olomouc, 77520, Czech Republic