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

This study has been completed.
Sponsor:
Information provided by:
Debiopharm International SA
ClinicalTrials.gov Identifier:
NCT00455767
First received: March 14, 2007
Last updated: June 23, 2008
Last verified: June 2008
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Debiopharm International SA:

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

Enrollment: 84
Study Start Date: July 2006
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00455767

Locations
France
Alain Mercat
Angers, France, 49933
Yves Castaing
Bordeaux, France, 33076
Laurent Brochard
Créteil Cedex, France, 94010
Jean-François Timsit
Grenoble Cedex 09, France, 38043
Claude Guerin
Lyon, France, 69004
Samir Jaber
Montpellier Cedex 05, France, 34295
Jean-Jacques Rouby
Paris, France, 75651
Jean-Daniel Chiche
Paris Cedex, France, 75679
Jean-Yves Fagon
Paris Cedex 15, France, 75908
Jean-Christophe Richard
Rouen Cedex, France, 76031
Jean-Michel Arnal
Toulon, France, 83100
Italy
Massimo Antonelli
Roma, Italy, 00168
Spain
Jordi Mancebo D.
Barcelona, Spain, 08025
Tunisia
Fekri Abroug
Monastir, Tunisia
Sponsors and Collaborators
Debiopharm International SA
Investigators
Study Director: François Saudubray, MD Debiopharm SA
  More Information

Additional Information:
Publications:
Responsible Party: François Saudubray, M.D., Debiopharm S.A.
ClinicalTrials.gov Identifier: NCT00455767     History of Changes
Other Study ID Numbers: DEB-EPIV-201, 2006-000756-41 (EUDRACT NR)
Study First Received: March 14, 2007
Last Updated: June 23, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Tunisia: Office of Pharmacies and Medicines
Italy: Ethics Committee
Spain: Spanish Agency of Medicines

Keywords provided by Debiopharm International SA:
persistent ARDS
alveolar inflammation
early pulmonary fibrosis
mechanichal ventilation
P/V curve
Static compliance
elastase activity
inhibitor of Human Neutrophil Elastase

Additional relevant MeSH terms:
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Fibrosis
Inflammation
Lung Diseases
Pulmonary Fibrosis
Respiration Disorders
Respiratory Distress Syndrome, Newborn
Respiratory Tract Diseases
Syndrome
Disease
Infant, Newborn, Diseases
Infant, Premature, Diseases
Lung Injury
Pathologic Processes

ClinicalTrials.gov processed this record on October 22, 2014