Pilot Study in Patients With Symptomatic Steroid-Naive Asthma

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Facet Biotech

ClinicalTrials.gov Identifier:

NCT00024544

First received: September 19, 2001

Last updated: March 6, 2012

Last verified: March 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	September 19, 2001
Last Updated Date	March 6, 2012
Start Date ^ICMJE	August 2001
Primary Completion Date	February 2003 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00024544 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

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	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Asthma
Intervention ^ICMJE	Drug: anti-IL-4 monoclonal antibody (pascolizumab)
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	120
Completion Date	February 2003
Primary Completion Date	February 2003 (final data collection date for primary outcome measure)
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 Number ^ICMJE	NCT00024544
Other Study ID Numbers ^ICMJE	683-803
Has Data Monitoring Committee	Not Provided
Responsible Party	Facet Biotech
Study Sponsor ^ICMJE	Facet Biotech
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Facet Biotech
Verification Date	March 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top