Safety and Efficacy Study of Depelestat in Acute Respiratory Distress Syndrome (ARDS) Patients

Sponsor

Debiopharm International SA (Industry)

Overall Status

Completed

CT.gov ID

NCT00455767

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study is aimed to assess safety of Depelestat treatment, as well as efficacy on prevention and treatment of alveolar inflammation in early pulmonary fibrosis in patients suffering from persistent Acute Respiratory Distress Syndrome.

Condition or Disease	Intervention/Treatment	Phase
Fibrosis Lung Disease Respiratory Disorders Respiratory Distress Syndrome, Adult Acute Respiratory Distress Syndrome Pulmonary Fibrosis Inflammation	Drug: EPI-hNE4 Drug: Placebo	Phase 2

Detailed Description

This is a multicenter, randomised, double-blind, parallel groups, placebo-controlled, 1 week treatment of Depelestat, in patients suffering from persistent ARDS.

Patients admitted in the intensive care unit presenting ARDS criteria persistent for 12 hours to 24 hours, will be randomly assigned to the treatment by Depelestat or placebo, after a pre-treatment period as short as possible with a maximum of 48 hours since ARDS criteria are met. During the pre-treatment period, the informed consent will be obtained from the legally authorized relative of the patient, and pre-treatment biological and functional examinations will be performed, particularly blood samples and BAL for biological parameters measurement, and ventilatory mechanics, for assessment of static compliance of the respiratory system.

After the pre-treatment period, the patient will receive treatment by Depelestat or placebo during 7 days, or until extubation of the patient if this occurs before 7 days of treatment. During this treatment period, the patient will be submitted to a daily measurement of static compliance of the respiratory system, as long as the patient adaptation to 24 hours after mechanical ventilation allows the procedure, and at 96 initiation of treatment, to a blood sampling and a bronchoalveolar lavage for several biological parameters assessment.

On the first and last day of administration, blood will be also collected for pharmacokinetic evaluation.

During the post-treatment period, the patient will be submitted, at 48 h ± 24 h after the end of treatment, to a blood sampling and a BAL (this BAL is not performed when contraindication criteria are present, if the patient is already extubated, and in case of planed extubation during the subsequent 24 hours) for several biological parameters assessment, and a daily measurement of static compliance as long as the patient adaptation to mechanical ventilation allows the procedure. Patients already extubated will not be submitted to BAL nor to static compliance measurements.

After the end of the treatment, patients will be followed daily for 28 days after the diagnostic of ARDS, or until death whichever occurred first.

The duration of the study for each survivor patient will be 28 days. Survivors to day 28 will be contacted monthly to assess survival and fill in a QOL questionnaire on days 60 and 90.

Study Design

Study Type:

Interventional

Actual Enrollment :

84 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Phase IIA Multicenter 1 Week Treatment, Randomised, Double-Blind, Placebo Controlled Study of Depelestat in Patients Suffering From Acute Respiratory Distress Syndrome

Study Start Date :

Jul 1, 2006

Actual Primary Completion Date :

Sep 1, 2007

Actual Study Completion Date :

Sep 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Depelestat	Drug: EPI-hNE4 I.V. injection of 1mg/kg Depelestat (EPI-hNE4) 3 times daily for 7 days
Placebo Comparator: 2 Placebo	Drug: Placebo Placebo

Arm

Intervention/Treatment

Active Comparator: 1

Depelestat

Drug: EPI-hNE4

I.V. injection of 1mg/kg Depelestat (EPI-hNE4) 3 times daily for 7 days

Placebo Comparator: 2

Placebo

Drug: Placebo

Placebo

Outcome Measures

Primary Outcome Measures

Static compliance relative change from pre-treatment to last on treatment []

Secondary Outcome Measures

PCPIII and cytokines concentration, as well as neutrophil influx relative change in BAL fluid from pre-treatment to post-treatment []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients suffering from persistent ARDS as defined by the American and European Consensus Conference on ARDS, 1994

Exclusion Criteria:

ARDS secondary to traumatism
Pulmonary emphysema on pulmonary fibrosis
Lung pneumocystosis
Bronchopleural fistula
Systemic corticosteroid treatment for more than 2 weeks before inclusion
Severe organ disease excepted renal

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Alain Mercat	Angers	France	49933
2	Yves Castaing	Bordeaux	France	33076
3	Laurent Brochard	Créteil Cedex	France	94010
4	Jean-François Timsit	Grenoble Cedex 09	France	38043
5	Claude Guerin	Lyon	France	69004
6	Samir Jaber	Montpellier Cedex 05	France	34295
7	Jean-Yves Fagon	Paris Cedex 15	France	75908
8	Jean-Daniel Chiche	Paris Cedex	France	75679
9	Jean-Jacques Rouby	Paris	France	75651
10	Jean-Christophe Richard	Rouen Cedex	France	76031
11	Jean-Michel Arnal	Toulon	France	83100
12	Massimo Antonelli	Roma	Italy	00168
13	Jordi Mancebo D.	Barcelona	Spain	08025
14	Fekri Abroug	Monastir	Tunisia