Pilot Study in Patients With Symptomatic Steroid-Naive Asthma - Tabular View

Tracking Information
First Received Date ^ICMJE	September 19, 2001
Last Updated Date	August 2, 2008
Start Date ^ICMJE	August 2001
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00024544 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Pilot Study in Patients With Symptomatic Steroid-Naive Asthma
Official Title ^ICMJE	A Phase I/II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Pilot Study of SB 240683 in Patients With Symptomatic Steroid-Naive Asthma
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.
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: anti-IL-4 monoclonal antibody (pascolizumab)
Study Arms / Comparison Groups
Publications *
* 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: 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
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	NCT00024544
Responsible Party
Study ID Numbers ^ICMJE	683-803
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