Dettagli per singolo studio

DEC-NET Serial number ES526

Published online	09/12/2005 10.41.00
Last updated	02/05/2006 12.30.16

Other protocol ID number	DEB-EPI-206
Current trial status	Closed to recruitment of participants: follow-up continuing
Major Disease (ICD9 class)	Cystic fibrosis
Experimental drug
depelestat Treatment regimen (dosage and duration) 5.65 mg/3 ml Depelestat twice daily or 11.3 mg/3 ml Depelestat twice daily, administered by nebulisation during 10 minutes, for 8 weeks
Gender	Both
Age (range)	above 6 years of age
Eligibility criteria
Inclusion criteria
Suffering from CF with a sweat chloride concentration above 60 mmol/L and/or proved by genotyping, with pulmonary disease of moderate severity, in stable stage
Exclusion criteria
Suffering from a severe pulmonary disease; 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 a 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 (unless stopped at least 6 weeks before start of treatment); taking a treatment with mucolytic drugs containing N-acetyl cystein (unless stopped at least 6 weeks before start of treatment)
Trial design/methodology
Phase	2
Kind of study	Safety
Design	Controlled Randomised Blinded Double blind
Purpose of study
To assess the safety of Depelestat administered twice daily for 8 weeks by inhalation after nebulisation in CF patients at 2 different doses.
Primary outcomes
Percentage of relative change of FEV1 on day 57, in relation to the basal one.
Secondary outcomes
Adverse events Vital signs Respiratory function parameters Biochemical and hematology changes Pharmacodynamic effects Pharmacokinetic effects