A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of 24 Weeks of Oral Treatment With BIIL 284 BS in Adult (75 mg, 150 mg) and Pediatric (75 mg) Cystic Fibrosis Patients

简要总结

主要结局

次要结局

• Change from baseline in pre-bronchodilator FEF25-75% % predicted(week 12, 24 and 28)
• 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 MEF50% % predicted(week 12, 24 and 28)
• Change from baseline in pre-bronchodilator MEF25%% predicted(week 12, 24 and 28)
• Proportion of patients with at least one pulmonary exacerbation during the treatment period as described in Rosenfeld et al.(28 weeks)
• Time to first pulmonary exacerbation(28 weeks)
• 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)