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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Enrollment
420
Change from baseline in post-bronchodilator forced expiratory volume in one second (FEV1) (percent predicted)
Time frame: 28 weeks
Proportion of patients with at least one pulmonary exacerbation during the treatment period as per definition of Fuchs et al
Time frame: 28 weeks
Change from baseline in post-bronchodilator forced vital capacity (FVC) percent predicted
Time frame: 28 weeks
Change from baseline in post-bronchodilator mean forced expiratory flow during the middle half of the FVC (FEF25-75% ) percent predicted
Time frame: 28 weeks
Change from baseline in post-bronchodilator maximal expiratory flow when 50% of FVC remains in lung (MEF50% )percent predicted
Time frame: 28 weeks
Change from baseline in post-bronchodilator maximal expiratory flow when 25% of FVC remains in lung (MEF25%) percent predicted
Time frame: 28 weeks
Change from baseline in post-bronchodilator inspiratory capacity (IC)
Time frame: 28 weeks
Change from baseline in post-bronchodilator slow vital capacity (SVC)
Time frame: 28 weeks
Change from baseline in pre-bronchodilator FEV1% predicted
Time frame: week 12, 24 and 28
Change from baseline in pre-bronchodilator FVC % predicted
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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
...and 25 more locations
Time frame: week 12, 24 and 28
Change from baseline in pre-bronchodilator FEF25-75% % predicted
Time frame: week 12, 24 and 28
Change from baseline in pre-bronchodilator MEF50% % predicted
Time frame: week 12, 24 and 28
Change from baseline in pre-bronchodilator MEF25%% predicted
Time frame: week 12, 24 and 28
Proportion of patients with at least one pulmonary exacerbation during the treatment period as described in Rosenfeld et al.
Time frame: 28 weeks
Time to first pulmonary exacerbation
Time frame: 28 weeks
Number of pulmonary exacerbations during the treatment period
Time frame: 28 weeks
Proportion of patients with at least 1 hospitalisation for a pulmonary exacerbation during the treatment period
Time frame: 28 weeks
Time to first hospitalisation for a pulmonary exacerbation
Time frame: 28 weeks
Number of hospitalisations for a pulmonary exacerbation
Time frame: 28 weeks
Number of days in hospital for a pulmonary exacerbation
Time frame: 28 weeks
Proportion of patients with at least one pulmonary exacerbation requiring i.v. antibiotics during the treatment period
Time frame: 28 weeks
Time to first course of i.v. antibiotics for a pulmonary exacerbation
Time frame: 28 weeks
Number of pulmonary exacerbations requiring i.v. antibiotics during the treatment period
Time frame: 28 weeks
Number of days of i.v. antibiotic use for pulmonary exacerbations during the treatment period
Time frame: 28 weeks
Change from baseline in weight
Time frame: 28 weeks
Change from baseline in height (in pediatrics)
Time frame: 28 weeks
Change from baseline in weight for age percentiles
Time frame: 28 weeks
Change from baseline in weight for age percentiles (in pediatrics)
Time frame: 28 weeks
Change from baseline in weight expressed as % ideal body weight (IBW)
Time frame: 28 weeks
Change from baseline in body mass index
Time frame: 28 weeks
Change from baseline in BMI for age percentiles
Time frame: 28 weeks
Change from baseline in blood levels of cytokines, chemokines and other inflammatory mediators
Time frame: 28 weeks
Change in patient's health status as reported by patient
Time frame: 28 weeks
Change in patient's health status as reported by physician
Time frame: 28 weeks