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

• Register: EUCTR
• Last refreshed on: 23 January 2017
• Main ID: EUCTR2004-002341-12-GB
• Date of registration: 10/02/2005
• Prospective Registration: Yes
• Primary sponsor: Debiopharm SA
• Public title: Multicenter, 8-week, Randomised, Double-Blind, Placebo Controlled Study of Two Doses of Depelestat in Cystic Fibrosis Patients
• Scientific title: Multicenter, 8-week, Randomised, Double-Blind, Placebo Controlled Study of Two Doses of Depelestat in Cystic Fibrosis Patients
• Date of first enrolment: 15/04/2005
• Target sample size: 90
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-002341-12
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, Germany, Italy, United Kingdom

Key inclusion & exclusion 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:
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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Cystic fibrosis
MedDRA version: 7.0 Level: PT Classification code 10011762

Intervention(s)

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: Engineered Protein Inhibitor of human Neutrophil Elastase
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5.65-
INN or Proposed INN: Depelestat
Current Sponsor code: EPI-hNE4 DX-890
Other descriptive name: Engineerd Protein Inhibitor of human Neutrophil Elastase
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 11.3-
Pharmaceutical form of the placebo: Powder for nebuliser solution
Route of administration of the placebo: Inhalation use

Primary Outcome(s)

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.

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.

Primary end point(s): FEV1 % predicted relative change from baseline to week 8

Secondary ID(s)

DEB-EPI-206

2004-002341-12-DE