Efficacy and Safety of 24 Weeks of Oral Treatment With BIIL 284 BS in Adult and Pediatric Patients
NCT ID: NCT00060801
Last Updated: 2013-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
420 participants
INTERVENTIONAL
2003-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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BIIL 283 BS (Amelubent)
Eligibility Criteria
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Inclusion Criteria
* Body weight \>= 20 kg (determined at Visit 1)
* Confirmed diagnosis of CF
* Able to perform acceptable spirometric maneuvers, according to American Thoracic Society standards .
* FEV1 25-85% predicted
* Clinically stable
* The patient or the patient's legally acceptable representative must be able to give informed consent.
* The patient must be able to swallow the BIIL 284 BS tablets whole.
* Patients taking a chronic medication must be willing to continue this therapy for the entire duration of the study.
Exclusion Criteria
* Patients who have participated in another study with an Investigational drug within one month or 6 half-lives (whichever is greater) preceding the screening visit.
* Patients with known relevant substance abuse, including alcohol or drug abuse.
* Female patients who are pregnant or lactating, including females who have a positive serum pregnancy test at screening (pregnancy tests will be performed for all females of child bearing potential).
* Female patients of child bearing potential who are not using a medically approved form of contraception.
* Patients who are unable to comply with food requirements prior to dosing.
* Patients with documented persistent colonization with Burkholderia cepacia.
* Patients chronically using oral corticosteroids or high-dose ibuprofen.
* Patients with hemoglobin \< 9.0 g/dL; platelets \< 100x10 to the 9th power/L; SGOT (ALT) or SGPT (AST) \> 2.5 times the upper limit of normal; creatinine \> 1.5 times upper limit normal.
* Clinically significant disease or medical condition other than Cystic Fibrosis or Cystic Fibrosis-related conditions that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data.
6 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Locations
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University of Arizona
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Children's Hospital of Los Angeles
Los Angeles, California, United States
Stanford University Medical Center
Palo Alto, California, United States
Children's Hospital & Health Center
San Diego, California, United States
University of California at San Francisco
San Francisco, California, United States
University of Colorado
Denver, Colorado, United States
The Nemours Children's Clinic
Orlando, Florida, United States
Pediatric Pulmonary Associates, PA
St. Petersburg, Florida, United States
Children's Memorial Hospital
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Riley Hospital
Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Kentucky
Lexington, Kentucky, United States
Tulane University
New Orleans, Louisiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Children's Hospital
Boston, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Washington University-St. Louis Children's Hospital
St Louis, Missouri, United States
University of Nebraska
Omaha, Nebraska, United States
Albany Medical College
Albany, New York, United States
University of Rochester
Rochester, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Children's Hospital Medical Center of Akron
Akron, Ohio, United States
Children's Hospital Medical Center
Cincinnati, Ohio, United States
Rainbow Babies & Children's Hospital
Cleveland, Ohio, United States
Columbus Children's Hospital
Columbus, Ohio, United States
MCP Hospital
Philadelphia, Pennsylvania, United States
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Vanderbilt Children's Hospital
Nashville, Tennessee, United States
Children's Memorial Center of Dallas
Dallas, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
University of Wisconsin Hospitals & Clinics
Madison, Wisconsin, United States
Countries
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Other Identifiers
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BI 543.45
Identifier Type: -
Identifier Source: org_study_id