Study of Daclizumab in Patients With Chronic, Persistent Asthma
A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Daclizumab in Patients With Chronic, Persistent Asthma
1 other identifier
interventional
120
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 asthma
Started Sep 2001
Typical duration for phase_2 asthma
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2001
CompletedFirst Submitted
Initial submission to the registry
December 19, 2001
CompletedFirst Posted
Study publicly available on registry
December 20, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2003
CompletedMarch 13, 2012
March 1, 2012
2.2 years
December 19, 2001
March 9, 2012
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients with 10 or more pack years of smoking history or smoking within 12 months of study enrollment
- No significant disease other than asthma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Facet Biotechlead
Study Sites (18)
Medical Research Associates
Long Beach, California, 90806, United States
Southern California Research
Mission Viejo, California, 92691, United States
Institute of Health Care Assessment, Inc.
San Diego, California, 92120, United States
Bensch Research Associates
Stockton, California, 95207, United States
National Jewish Medical and Research Center
Denver, Colorado, 80206, United States
Clinical Reserch Centers of Colorado
Denver, Colorado, 80230, United States
Florida Center for Allergy and Asthma Reserch
Miami, Florida, 33176, United States
Rx Research
Woodstock, Georgia, 30188, United States
ICSL Clinical Studies
Bloomington, Illinois, 61704, United States
Asthma and Allergy Center of Chicago, S.C.
River Forest, Illinois, 60305, United States
New England Clinical Studies
North Dartmouth, Massachusetts, 02747, United States
Clinical Research Institute
Minneapolis, Minnesota, 55402, United States
Princeton Center for Clinical Research
Princeton, New Jersey, 08540, United States
Allergy, Asthma, and Dermatology Research Center, LLC
Lake Oswego, Oregon, 97035, United States
Valley Clinical Research Center
Easton, Pennsylvania, 18045, United States
Pharmaceutical Research and Consulting, Inc.
Dallas, Texas, 75231, United States
University of Wisconsin Medical School
Madison, Wisconsin, 53792, United States
Allergy and Respiratory Care Center
Milwaukee, Wisconsin, 53209, United States
Related Publications (1)
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.
PMID: 18787222DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2001
First Posted
December 20, 2001
Study Start
September 1, 2001
Primary Completion
December 1, 2003
Study Completion
December 1, 2003
Last Updated
March 13, 2012
Record last verified: 2012-03