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Study of Daclizumab in Patients With Chronic, Persistent Asthma

Primary Purpose

Asthma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Daclizumab
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, Daclizumab, anti-Tac monoclonal antibody, anti-IL-2, Zenapax

Eligibility Criteria

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

Inclusion Criteria: History of asthma for 6 or more months History of chronic persistent asthma requiring daily high dose inhaled corticosteroid for 3 or more months prior to enrollment Exclusion Criteria: Patients with 10 or more pack years of smoking history or smoking within 12 months of study enrollment No significant disease other than asthma

Sites / Locations

  • Medical Research Associates
  • Southern California Research
  • Institute of Health Care Assessment, Inc.
  • Bensch Research Associates
  • National Jewish Medical and Research Center
  • Clinical Reserch Centers of Colorado
  • Florida Center for Allergy and Asthma Reserch
  • Rx Research
  • ICSL Clinical Studies
  • Asthma and Allergy Center of Chicago, S.C.
  • New England Clinical Studies
  • Clinical Research Institute
  • Princeton Center for Clinical Research
  • Allergy, Asthma, and Dermatology Research Center, LLC
  • Valley Clinical Research Center
  • Pharmaceutical Research and Consulting, Inc.
  • University of Wisconsin Medical School
  • Allergy and Respiratory Care Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 19, 2001
Last Updated
March 9, 2012
Sponsor
Facet Biotech
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1. Study Identification

Unique Protocol Identification Number
NCT00028288
Brief Title
Study of Daclizumab in Patients With Chronic, Persistent Asthma
Official Title
A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Daclizumab in Patients With Chronic, Persistent Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
December 2003 (Actual)
Study Completion Date
December 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 persistent asthma. The research is being conducted at up to 22 clinical research sites in the US and is open to both men and women ages 18 to 70 years old. Participants in the study will have a number of visits to a research site over a 10-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, Daclizumab, anti-Tac monoclonal antibody, anti-IL-2, Zenapax

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)
Daclizumab

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: History of asthma for 6 or more months History of chronic persistent asthma requiring daily high dose inhaled corticosteroid for 3 or more months prior to enrollment Exclusion Criteria: Patients with 10 or more pack years of smoking history or smoking within 12 months of study enrollment No significant disease other than asthma
Facility Information:
Facility Name
Medical Research Associates
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Southern California Research
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Institute of Health Care Assessment, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92120
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
Clinical Reserch Centers of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Florida Center for Allergy and Asthma Reserch
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Rx Research
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30188
Country
United States
Facility Name
ICSL Clinical Studies
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61704
Country
United States
Facility Name
Asthma and Allergy Center of Chicago, S.C.
City
River Forest
State/Province
Illinois
ZIP/Postal Code
60305
Country
United States
Facility Name
New England Clinical Studies
City
North 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
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
Pharmaceutical Research and Consulting, Inc.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
University of Wisconsin Medical School
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Allergy and Respiratory Care Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18787222
Citation
Busse WW, Israel E, Nelson HS, Baker JW, Charous BL, Young DY, Vexler V, Shames RS; Daclizumab Asthma Study Group. Daclizumab improves asthma control in patients with moderate to severe persistent asthma: a randomized, controlled trial. Am J Respir Crit Care Med. 2008 Nov 15;178(10):1002-8. doi: 10.1164/rccm.200708-1200OC. Epub 2008 Sep 11.
Results Reference
derived

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Study of Daclizumab in Patients With Chronic, Persistent Asthma

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