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Pilot Study in Patients With Symptomatic Steroid-Naive Asthma

Primary Purpose

Asthma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
anti-IL-4 monoclonal antibody (pascolizumab)
Sponsored by
Facet Biotech
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring asthma, anti-IL-4 monoclonal antibody, pascolizumab

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Allergy Research Foundation
  • Southern California Research
  • Clinical Trials of Orange Cnty., Inc.
  • Allergy Associates Medical Group, Inc.
  • Allergy and Asthma Associates Santa Clara Valley Research Center
  • Bensch Research Associates
  • National Jewish Medical and Research Center
  • ICSL Clinical Studies
  • Respiratory Therapy and Pulmonary Clinical Research Brigham & Women's Hospital
  • New England Clinical Studies
  • Clinical Research Institute
  • The Clinical Research Center, LLC
  • Center for Allergy, Asthma and Immunology, Creighton University
  • Princeton Center for Clinical Research
  • Allergy, Asthma, and Dermatology Research Center, LLC
  • Valley Clinical Research Center
  • Clinical Trials North Houston
  • University of Wisconsin Medical School

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 19, 2001
Last Updated
March 6, 2012
Sponsor
Facet Biotech
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1. Study Identification

Unique Protocol Identification Number
NCT00024544
Brief Title
Pilot Study in Patients With Symptomatic Steroid-Naive Asthma
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
February 2003 (Actual)
Study Completion Date
February 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Facet Biotech

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma, anti-IL-4 monoclonal antibody, pascolizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
120 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
anti-IL-4 monoclonal antibody (pascolizumab)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Allergy Research Foundation
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Southern California Research
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Clinical Trials of Orange Cnty., Inc.
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Allergy Associates Medical Group, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Allergy and Asthma Associates Santa Clara Valley Research Center
City
San Jose
State/Province
California
ZIP/Postal Code
95117
Country
United States
Facility Name
Bensch Research Associates
City
Stockton
State/Province
California
ZIP/Postal Code
95207
Country
United States
Facility Name
National Jewish Medical and Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
ICSL Clinical Studies
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Respiratory Therapy and Pulmonary Clinical Research Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
New England Clinical Studies
City
N. Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Clinical Research Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
The Clinical Research Center, LLC
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Center for Allergy, Asthma and Immunology, Creighton University
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Princeton Center for Clinical Research
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Name
Allergy, Asthma, and Dermatology Research Center, LLC
City
Lake Oswego
State/Province
Oregon
ZIP/Postal Code
97035
Country
United States
Facility Name
Valley Clinical Research Center
City
Easton
State/Province
Pennsylvania
ZIP/Postal Code
18045
Country
United States
Facility Name
Clinical Trials North Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
University of Wisconsin Medical School
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

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Pilot Study in Patients With Symptomatic Steroid-Naive Asthma

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