Pilot Study in Patients With Symptomatic Steroid-Naive Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Facet Biotech
ClinicalTrials.gov Identifier:
NCT00024544
First received: September 19, 2001
Last updated: March 6, 2012
Last verified: March 2012
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Facet Biotech:

Estimated Enrollment: 120
Study Start Date: August 2001
Study Completion Date: February 2003
Primary Completion Date: February 2003 (Final data collection date for primary outcome measure)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Allergy Research Foundation
Los Angeles, California, United States, 90025
Southern California Research
Mission Viejo, California, United States, 92691
Clinical Trials of Orange Cnty., Inc.
Orange, California, United States, 92868
Allergy Associates Medical Group, Inc.
San Diego, California, United States, 92120
Allergy and Asthma Associates Santa Clara Valley Research Center
San Jose, California, United States, 95117
Bensch Research Associates
Stockton, California, United States, 95207
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
Respiratory Therapy and Pulmonary Clinical Research Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
New England Clinical Studies
N. Dartmouth, Massachusetts, United States, 02747
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
Facet Biotech
  More Information

No publications provided

Responsible Party: Facet Biotech
ClinicalTrials.gov Identifier: NCT00024544     History of Changes
Other Study ID Numbers: 683-803
Study First Received: September 19, 2001
Last Updated: March 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Facet Biotech:
asthma
anti-IL-4 monoclonal antibody
pascolizumab

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014