ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Safety and Efficacy Study of Depelestat in Acute Respiratory Distress Syndrome (ARDS) Patients

This study has been completed.

Sponsored by: Debiopharm S.A.
Information provided by: Debiopharm S.A.
ClinicalTrials.gov Identifier: NCT00455767
  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 II

MedlinePlus related topics:   Pulmonary Fibrosis   

Drug Information available for:   Depelestat   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:   Phase IIA Multicenter 1 Week Treatment, Randomised, Double-Blind, Placebo Controlled Study of Depelestat in Patients Suffering From Acute Respiratory Distress Syndrome

Further study details as provided by Debiopharm S.A.:

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

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

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

Sponsors and Collaborators
Debiopharm S.A.

Investigators
Study Director:     François Saudubray, MD     Debiopharm SA    
  More Information


Related Info  This link exits the ClinicalTrials.gov site
 

Publications:

Responsible Party:   Debiopharm S.A. ( François Saudubray, M.D. )
Study ID Numbers:   DEB-EPIV-201, 2006-000756-41 (EUDRACT NR)
First Received:   March 14, 2007
Last Updated:   June 23, 2008
ClinicalTrials.gov Identifier:   NCT00455767
Health Authority:   France: Afssaps - French Health Products Safety Agency;   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 S.A.:
persistent ARDS  
alveolar inflammation  
early pulmonary fibrosis  
mechanichal ventilation  
P/V curve
Static compliance
elastase activity
inhibitor of Human Neutrophil Elastase

Study placed in the following topic categories:
Lung Diseases, Interstitial
Respiratory Tract Diseases
Fibrosis
Lung Diseases
Respiration Disorders
Respiratory Distress Syndrome, Adult
Acute respiratory distress syndrome
Pulmonary Fibrosis
Inflammation

Additional relevant MeSH terms:
Disease
Pathologic Processes
Syndrome

ClinicalTrials.gov processed this record on October 22, 2008




Links to all studies - primarily for crawlers