Efficacy and Safety of 24 Weeks of Oral Treatment With BIIL 284 BS in Adult and Pediatric Patients
- Conditions
- Cystic Fibrosis
- Registration Number
- NCT00060801
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The purpose of this study is to determine the effect of 24 weeks of treatment with BIIL 284 BS compared with placebo on pulmonary function and incidence of pulmonary exacerbation in adult and pediatric cystic fibrosis patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 420
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in post-bronchodilator forced expiratory volume in one second (FEV1) (percent predicted) 28 weeks Proportion of patients with at least one pulmonary exacerbation during the treatment period as per definition of Fuchs et al 28 weeks
- Secondary Outcome Measures
Name Time Method Time to first pulmonary exacerbation 28 weeks Proportion of patients with at least one pulmonary exacerbation during the treatment period as described in Rosenfeld et al. 28 weeks Change from baseline in post-bronchodilator forced vital capacity (FVC) percent predicted 28 weeks Change from baseline in post-bronchodilator mean forced expiratory flow during the middle half of the FVC (FEF25-75% ) percent predicted 28 weeks Change from baseline in post-bronchodilator inspiratory capacity (IC) 28 weeks Change from baseline in pre-bronchodilator FEV1% predicted week 12, 24 and 28 Change from baseline in pre-bronchodilator FVC % predicted week 12, 24 and 28 Change from baseline in pre-bronchodilator FEF25-75% % predicted week 12, 24 and 28 Change from baseline in pre-bronchodilator MEF50% % predicted week 12, 24 and 28 Change from baseline in pre-bronchodilator MEF25%% predicted week 12, 24 and 28 Number of pulmonary exacerbations during the treatment period 28 weeks Proportion of patients with at least 1 hospitalisation for a pulmonary exacerbation during the treatment period 28 weeks Time to first hospitalisation for a pulmonary exacerbation 28 weeks Number of hospitalisations for a pulmonary exacerbation 28 weeks Number of days in hospital for a pulmonary exacerbation 28 weeks Proportion of patients with at least one pulmonary exacerbation requiring i.v. antibiotics during the treatment period 28 weeks Time to first course of i.v. antibiotics for a pulmonary exacerbation 28 weeks Number of pulmonary exacerbations requiring i.v. antibiotics during the treatment period 28 weeks Number of days of i.v. antibiotic use for pulmonary exacerbations during the treatment period 28 weeks Change from baseline in weight 28 weeks Change from baseline in height (in pediatrics) 28 weeks Change from baseline in weight for age percentiles 28 weeks Change from baseline in weight for age percentiles (in pediatrics) 28 weeks Change from baseline in weight expressed as % ideal body weight (IBW) 28 weeks Change from baseline in body mass index 28 weeks Change from baseline in BMI for age percentiles 28 weeks Change from baseline in blood levels of cytokines, chemokines and other inflammatory mediators 28 weeks Change in patient's health status as reported by patient 28 weeks Change in patient's health status as reported by physician 28 weeks Change from baseline in post-bronchodilator maximal expiratory flow when 50% of FVC remains in lung (MEF50% )percent predicted 28 weeks Change from baseline in post-bronchodilator maximal expiratory flow when 25% of FVC remains in lung (MEF25%) percent predicted 28 weeks Change from baseline in post-bronchodilator slow vital capacity (SVC) 28 weeks
Trial Locations
- Locations (35)
St. Christopher's Hospital for Children
🇺🇸Philadelphia, Pennsylvania, United States
Washington University-St. Louis Children's Hospital
🇺🇸St. Louis, Missouri, United States
Children's Hospital Medical Center of Akron
🇺🇸Akron, Ohio, United States
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
University of Arizona
🇺🇸Tucson, Arizona, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Tulane University
🇺🇸New Orleans, Louisiana, United States
Children's Memorial Hospital
🇺🇸Chicago, Illinois, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Children's Hospital of Los Angeles
🇺🇸Los Angeles, California, United States
Stanford University Medical Center
🇺🇸Palo Alto, California, United States
The Nemours Children's Clinic
🇺🇸Orlando, Florida, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
University of Rochester
🇺🇸Rochester, New York, United States
Pediatric Pulmonary Associates, PA
🇺🇸St. Petersburg, Florida, United States
Albany Medical College
🇺🇸Albany, New York, United States
Children's Memorial Center of Dallas
🇺🇸Dallas, Texas, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
MCP Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Columbus Children's Hospital
🇺🇸Columbus, Ohio, United States
University of Wisconsin Hospitals & Clinics
🇺🇸Madison, Wisconsin, United States
Children's Hospital & Health Center
🇺🇸San Diego, California, United States
Riley Hospital
🇺🇸Indianapolis, Indiana, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Children's Hospital
🇺🇸Boston, Massachusetts, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Texas Children's Hospital
🇺🇸Houston, Texas, United States
Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
University of California at San Francisco
🇺🇸San Francisco, California, United States
University of Nebraska
🇺🇸Omaha, Nebraska, United States
University of Colorado
🇺🇸Denver, Colorado, United States
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
Vanderbilt Children's Hospital
🇺🇸Nashville, Tennessee, United States
Rainbow Babies & Children's Hospital
🇺🇸Cleveland, Ohio, United States