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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00455767
Recruitment Status : Completed
First Posted : April 4, 2007
Last Update Posted : June 24, 2008
Information provided by:
Debiopharm International SA

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.

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Study Type : Interventional  (Clinical Trial)
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 : July 2006
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

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

Placebo Comparator: 2
Drug: Placebo

Primary Outcome Measures :
  1. Static compliance relative change from pre-treatment to last on treatment

Secondary Outcome Measures :
  1. PCPIII and cytokines concentration, as well as neutrophil influx relative change in BAL fluid from pre-treatment to post-treatment

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00455767

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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-Yves Fagon
Paris Cedex 15, France, 75908
Jean-Daniel Chiche
Paris Cedex, France, 75679
Jean-Jacques Rouby
Paris, France, 75651
Jean-Christophe Richard
Rouen Cedex, France, 76031
Jean-Michel Arnal
Toulon, France, 83100
Massimo Antonelli
Roma, Italy, 00168
Jordi Mancebo D.
Barcelona, Spain, 08025
Fekri Abroug
Monastir, Tunisia
Sponsors and Collaborators
Debiopharm International SA
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Study Director: François Saudubray, MD Debiopharm SA
Additional Information:
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Responsible Party: François Saudubray, M.D., Debiopharm S.A. Identifier: NCT00455767    
Other Study ID Numbers: DEB-EPIV-201
2006-000756-41 (EUDRACT NR)
First Posted: April 4, 2007    Key Record Dates
Last Update Posted: June 24, 2008
Last Verified: June 2008
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:
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Lung Diseases
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Pulmonary Fibrosis
Acute Lung Injury
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury