Multicenter, 8-week, Randomised, Double-Blind, Placebo Controlled Study of Two Doses of Depelestat in Cystic Fibrosis Patients

Debiopharm SA0 个研究点目标入组 90 人开始时间: 2005年8月25日最近更新: 2012年3月19日

适应症

试验速览

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•Male or female patient above 6 years of age
•Suffering from CF with a sweat chloride concentration above 60 mmol/L and/or proved by genotyping
•With a negative pregnancy test if female of childbearing potential, and taking adequate contraception precautions during the duration of the study
•With pulmonary disease of moderate severity defined as: less than 80% but at least 30% FEV1 predicted values at each baseline measurement (V-2, V-1 and V1 before treatment)
•With pulmonary disease in stable stage defined as:
•-maximal FEV1 variation by 10 %, between the 3 baseline values obtained during the pre-treatment period and on Day 1 before the first drug administration
•-no acute pulmonary exacerbation (APE) during the 6 previous weeks before treatment start (at least 4 weeks before V-2)
•Able to perform PFT (spirometry) with reproducible values
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Suffering from a severe pulmonary disease : FEV <30% and /or FVC <40% of predicted values for any baseline measurement at V-2, -1 and V1 before nebulisation
•Having suffered from an acute exacerbation of pulmonary disease according to the definition of Fuchs with IV antibiotics treatment, within 6 weeks before start of treatment
•Having been admitted to hospital for treatment of their disease during the 6 weeks before start of treatment
•Suffering from allergic bronchopulmonary aspergillosis (ABPA) with related clinical signs as bronchospams or asthmatic manifestations
•Presenting an identified bronchial hyperresponsiveness with an history of asthma with episodes of wheezing
•Having an history of significant haemoptysis (except hemoptoïc expectoration)
•Presenting a bronchopulmonary colonisation by Bukholderia Cepacia, according to the last sputum bacterial examination
•Having changed their chronic therapy, including chest physiotherapy and drugs, less than 6 weeks (2 cycles for inhaled Tobramycin) before start of treatment
•Routine IV antibiotic treatment : patients receiving IV antibiotics at planned regular interval of time.
•Chronic use of oral corticosteroids (to be stopped at least 6 weeks before start of treatment)
•Taking a treatment with mucolytic drugs containing N-acetyl cystein (to be stopped at least 6 weeks before start of treatment

发起方

Debiopharm SA