Study of Daclizumab in Patients With Chronic, Persistent Asthma - Tabular View

Tracking Information
First Received Date ^ICMJE	December 19, 2001
Last Updated Date	August 2, 2008
Start Date ^ICMJE	September 2001
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00028288 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Study of Daclizumab in Patients With Chronic, Persistent Asthma
Official Title ^ICMJE	A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Daclizumab in Patients With Chronic, Persistent Asthma
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.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Asthma
Intervention ^ICMJE	Drug: Daclizumab
Study Arms / Comparison Groups
Publications *	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. Epub 2008 Sep 11.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	120
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00028288
Responsible Party
Study ID Numbers ^ICMJE	DAC-1003
Study Sponsor ^ICMJE	PDL BioPharma, Inc.
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Facet Biotech
Verification Date	August 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP