Pilot Study in Patients With Symptomatic Steroid-Naive Asthma
A Phase I/II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Pilot Study of SB 240683 in Patients With Symptomatic Steroid-Naive 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 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.
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 Aug 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
August 1, 2001
CompletedFirst Submitted
Initial submission to the registry
September 19, 2001
CompletedFirst Posted
Study publicly available on registry
September 20, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2003
CompletedMarch 7, 2012
March 1, 2012
1.5 years
September 19, 2001
March 6, 2012
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- At least a 6-month history of asthma
- No use of inhaled, oral or injectable steroids for at least 1 month prior to enrollment
You may not qualify if:
- Patients with \> 10 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)
Allergy Research Foundation
Los Angeles, California, 90025, United States
Southern California Research
Mission Viejo, California, 92691, United States
Clinical Trials of Orange Cnty., Inc.
Orange, California, 92868, United States
Allergy Associates Medical Group, Inc.
San Diego, California, 92120, United States
Allergy and Asthma Associates Santa Clara Valley Research Center
San Jose, California, 95117, United States
Bensch Research Associates
Stockton, California, 95207, United States
National Jewish Medical and Research Center
Denver, Colorado, 80206, United States
ICSL Clinical Studies
Normal, Illinois, 61761, United States
Respiratory Therapy and Pulmonary Clinical Research Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
New England Clinical Studies
North Dartmouth, Massachusetts, 02747, United States
Clinical Research Institute
Minneapolis, Minnesota, 55402, United States
The Clinical Research Center, LLC
St Louis, Missouri, 63141, United States
Center for Allergy, Asthma and Immunology, Creighton University
Omaha, Nebraska, 68131, 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
Clinical Trials North Houston
Houston, Texas, 77090, United States
University of Wisconsin Medical School
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Condition 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
September 19, 2001
First Posted
September 20, 2001
Study Start
August 1, 2001
Primary Completion
February 1, 2003
Study Completion
February 1, 2003
Last Updated
March 7, 2012
Record last verified: 2012-03