Clinical trial NCT00028288: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Asthma
Daclizumab
anti-Tac monoclonal antibody
anti-IL-2
Zenapax
Lead sponsor: Facet Biotech
Sponsor class: INDUSTRY
First posted: 2001-12-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Medical Research Associates
state: California
city: Mission Viejo
country: United States
facility: Southern California Research
state: California
city: San Diego
country: United States
facility: Institute of Health Care Assessment, Inc.
state: California
city: Stockton
country: United States
facility: Bensch Research Associates
state: California
city: Denver
country: United States
facility: National Jewish Medical and Research Center
state: Colorado
city: Denver
country: United States
facility: Clinical Reserch Centers of Colorado
state: Colorado
city: Miami
country: United States
facility: Florida Center for Allergy and Asthma Reserch
state: Florida
city: Woodstock
country: United States
facility: Rx Research
state: Georgia
city: Bloomington
country: United States
facility: ICSL Clinical Studies
state: Illinois
city: River Forest
country: United States
facility: Asthma and Allergy Center of Chicago, S.C.
state: Illinois
city: North Dartmouth
country: United States
facility: New England Clinical Studies
state: Massachusetts
city: Minneapolis
country: United States
facility: Clinical Research Institute
state: Minnesota
city: Princeton
country: United States
facility: Princeton Center for Clinical Research
state: New Jersey
city: Lake Oswego
country: United States
facility: Allergy, Asthma, and Dermatology Research Center, LLC
state: Oregon
city: Easton
country: United States
facility: Valley Clinical Research Center
state: Pennsylvania
city: Dallas
country: United States
facility: Pharmaceutical Research and Consulting, Inc.
state: Texas
city: Madison
country: United States
facility: University of Wisconsin Medical School
state: Wisconsin
city: Milwaukee
country: United States
facility: Allergy and Respiratory Care Center
state: Wisconsin
Study officials:
References:
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.