Pilot Study in Patients With Symptomatic Steroid-Naive Asthma - Full Text View

Purpose

The purpose of the study is to evaluate an investigational medication to treat chronic asthma. The research is being conducted at 20 clinical research sites in the US and is open to both men and women ages 18 to 70 years. Participants in the study will have a number of visits to a research site over an 8-month period. All study-related care and medication is provided to qualified participants at no cost. This includes all visits, examinations and laboratory work.

Condition	Intervention	Phase
Asthma	Drug: anti-IL-4 monoclonal antibody (pascolizumab)	Phase II

MedlinePlus related topics:

Asthma

Drug Information available for:

Pascolizumab

U.S. FDA Resources

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

Official Title:	A Phase I/II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Pilot Study of SB 240683 in Patients With Symptomatic Steroid-Naive Asthma

Further study details as provided by PDL BioPharma, Inc.:

Estimated Enrollment:	120
Study Start Date:	August 2001

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

At least a 6-month history of asthma
No use of inhaled, oral or injectable steroids for at least 1 month prior to enrollment

Exclusion Criteria:

Patients with > 10 pack years of smoking history or smoking within 12 months of study enrollment
No significant disease other than asthma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00024544

Locations


United States, California
	Bensch Research Associates
	Stockton, California, United States, 95207
	Southern California Research
	Mission Viejo, California, United States, 92691
	Allergy Research Foundation
	Los Angeles, California, United States, 90025
	Clinical Trials of Orange Cnty., Inc.
	Orange, California, United States, 92868
	Allergy and Asthma Associates Santa Clara Valley Research Center
	San Jose, California, United States, 95117
	Allergy Associates Medical Group, Inc.
	San Diego, California, United States, 92120

United States, Colorado
	National Jewish Medical and Research Center
	Denver, Colorado, United States, 80206

United States, Illinois
	ICSL Clinical Studies
	Normal, Illinois, United States, 61761

United States, Massachusetts
	New England Clinical Studies
	N. Dartmouth, Massachusetts, United States, 02747
	Respiratory Therapy and Pulmonary Clinical Research Brigham & Women's Hospital
	Boston, Massachusetts, United States, 02115

United States, Minnesota
	Clinical Research Institute
	Minneapolis, Minnesota, United States, 55402

United States, Missouri
	The Clinical Research Center, LLC
	St. Louis, Missouri, United States, 63141

United States, Nebraska
	Center for Allergy, Asthma and Immunology, Creighton University
	Omaha, Nebraska, United States, 68131

United States, New Jersey
	Princeton Center for Clinical Research
	Princeton, New Jersey, United States, 08540

United States, Oregon
	Allergy, Asthma, and Dermatology Research Center, LLC
	Lake Oswego, Oregon, United States, 97035

United States, Pennsylvania
	Valley Clinical Research Center
	Easton, Pennsylvania, United States, 18045

United States, Texas
	Clinical Trials North Houston
	Houston, Texas, United States, 77090

United States, Wisconsin
	University of Wisconsin Medical School
	Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

PDL BioPharma, Inc.

More Information

Study ID Numbers:	683-803
First Received:	September 19, 2001
Last Updated:	August 2, 2008
ClinicalTrials.gov Identifier:	NCT00024544
Health Authority:	United States: Food and Drug Administration

Keywords provided by PDL BioPharma, Inc.:

asthma

anti-IL-4 monoclonal antibody

pascolizumab

Study placed in the following topic categories:

Antibodies, Monoclonal

Antibodies

Hypersensitivity

Lung Diseases, Obstructive

Respiratory Tract Diseases

Lung Diseases

Hypersensitivity, Immediate

Asthma

Respiratory Hypersensitivity

Additional relevant MeSH terms:

Immunologic Factors

Immune System Diseases

Bronchial Diseases

Physiological Effects of Drugs

Pharmacologic Actions

ClinicalTrials.gov processed this record on December 03, 2008

Sponsored by:	PDL BioPharma, Inc.
Information provided by:	PDL BioPharma, Inc.
ClinicalTrials.gov Identifier:	NCT00024544