Cystic fibrosis MedDRA version: 7.0 Level: PT Classification code 10011762
Conditions
Interventions
Product Name: Depelestat
Product Code: EPI-hNE4 DX-890
Pharmaceutical Form: Powder for nebuliser solution
INN or Proposed INN: Depelestat
Current Sponsor code: EPIhNE4 DX-890
Other descriptive name: E
Sponsors
Debiopharm SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety of Depelestat in CF patients with moderate pulmonary disease, particularly regarding the PFT evolution on treatment, compared to placebo.;Secondary Objective: To compare two doses of Depelestat in terms of pharmacodynamic effect, by measuring change in hNE activity in sputum during the treatment period and the post-treatment period by comparison with the pre-treatment period.;Primary end point(s): FEV1 % predicted relative change from baseline to week 8 | — |
Countries
Belgium, Germany, Italy, United Kingdom
Outcome results
None listed