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Protocol Chronic Obstructive Pulmonary Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2006 by University Hospital, Grenoble.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00404430
First received: November 27, 2006
Last updated: August 24, 2007
Last verified: November 2006
History of Changes
  Purpose

The main objective of the study is to evaluate the predictive factors of the endothelial function to the waning of an acute exacerbation in COPD. It will act to do a multivariate analysis to determine the respective weight of the parameters of the systemic inflammation, of the oxidative stress of the functional respiratory parameters and then functional respiratory parameters.

In exacerbated COPD patients, there is augmentation of hypoxia and the obstructive ventilatory disorders is more important. This is correlated with an increase in CRP and of inflammatory cytokines and oxidative stress. It has been demonstrated that there is an endothelial dysfunction in answer to hypoxia. Since the exacerbated COPD patients are hypoxic in most cases , we suppose they have an endothelial dysfunction during exacerbation. So we think we will find an augmentation of vascular resistances ,shown by a peripheral arterial tone too high. And this , certainly, play a part in physiopathology of the COPD exacerbation.


Condition
Chronic Obstructive Pulmonary Disease
Acute Respiratory Failure

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Predictive Factors of Endothelial Function in Chronic Obstructive Disease Patients at the End of a Acute Exacerbation.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Grenoble:

Estimated Enrollment: 100
Study Start Date: January 2007
Estimated Study Completion Date: December 2008
Detailed Description:

We want to judge the improvement of the endothelial function remotely to the acute exacerbation ( 6 weeks). And then we would like to correlate this improvement with the variations of oxidative stress, the muscular strenght, the respiratory function and the systemic inflammation.

We also would like to find a relation between the new hospitalizations for respiratory exacerbation and the initial value of endothelial function.

  Eligibility

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

Inclusion Criteria:

  • COPD patients with the waning of exacerbation:

    • Male or Female more than 18 years old
    • VEF1/FCV < 70% or COPD already knew

    • At the moment of the respiratory failure, the day of the enter in hospital:

      • Respiratory frequency >25
      • PaCO2 >45 mmHg
      • pH < 7.35

    • The day of the inclusion in our study:

      • PH > 7.33 at the end of the respiratory failure, or 2 days of continuation, 3 to 7 days post acute exacerbation of continuation
      • Fever < 38.5
    • Patients who have signed the inform consent form

  • Stable COPD patients:

    • Men or women more than 18 years old
    • VEF1/FCV < 70% or COPD already knew
    • Patients who have signed the inform consent form

Exclusion Criteria:

  • Evolutive obvious infection or CRP >100 at inclusion Cardiac failure considered like the major cause of the exacerbation or cardiac insufficiency with FeVG < 45 %
  • Smoker > 10 cigarettes a day Antioxidant catch: N-acetyl-cystein, selenium, ascorbic acid, alpha tocopherol acetate…
  • Evolutive neoplasy
  • Antioxidant catch: N-acetyl-cystein, selenium, ascorbic acid, alpha tocopherol acetate…
  • pregnant women
  • patient under supervision or trusteeship
  • patient taking part in another clinical trial.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00404430

Contacts
Contact: Jean-Louis JP PEPIN, ProfessorPhD 0033476765516 JPepin@chu-grenoble.fr

Locations
France
France : Laboratoire EFCR - Functional Cardio-Respiratory Exploration Laboratory Recruiting
Grenoble, Isere, France, 38043
Contact: Jean-Louis JP PEPIN, ProfessorPHD     0033476765516     JPepin@chu-grenoble.fr    
Sub-Investigator: Jean-Philippe JB BAGUET, ProfessorPHD            
Sub-Investigator: Patrick PL LEVY, ProfessorPHD            
Sub-Investigator: Jean-François JT TIMSIT, ProfessorPHD            
Sub-Investigator: Patrice PF FAURE, PhD            
Sub-Investigator: Christophe CP PISON, ProfessorPHD            
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Jean-Louis JP Pépin, ProfessorPhD University Hospital, Grenoble
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00404430     History of Changes
Other Study ID Numbers: 0627
Study First Received: November 27, 2006
Last Updated: August 24, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Grenoble:
Endothelial function
Peripheral Arterial Tone
Systemic Inflammation
Oxidative Stress
Respiratory and peripheral muscular function

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Respiratory Distress Syndrome, Adult
 Respiratory Insufficiency
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013