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Protocol Chronic Obstructive Pulmonary Disease

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: NCT00404430
Recruitment Status : Active, not recruiting
First Posted : November 28, 2006
Last Update Posted : January 18, 2020
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:

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 Chronic Obstructive Pulmonary Disease (COPD) patients, there is augmentation of hypoxia and the obstructive ventilatory disorders is more important. This is correlated with an increase in C-reactive Protein (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 or disease
Chronic Obstructive Pulmonary Disease Acute Respiratory Failure

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, muscle strength, respiratory function and systemic inflammation.

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

Then we would like to evaluate the relationship between the cardiovascular risk and the COPD severity.

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Study Type : Observational
Actual Enrollment : 121 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictive Factors of Endothelial Function in Chronic Obstructive Disease Patients at the End of a Acute Exacerbation.
Study Start Date : January 2007
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Exacerbated COPD patients
Patients with exacerbated COPD
Stable COPD patients
Patients with stable COPD

Primary Outcome Measures :
  1. peripheral arterial tone [ Time Frame: once a year ]

Secondary Outcome Measures :
  1. Muscle strength measurements [ Time Frame: once a year ]
  2. biological markers of inflammation and oxidative stress [ Time Frame: once a year ]
  3. respiratory function measurements [ Time Frame: once a year ]
  4. Determine the relationship between the RMI measurements and the cardiovascular risk [ Time Frame: once during the study ]
  5. Determine the relationship between the hospitalizations for decompensation and the initial value of endothelial function [ Time Frame: study time frame ]
  6. Determine the relationship between the RMI measurements and the COPD severity [ Time Frame: once during the study ]
  7. Determine the prevalence of nocturnal non-dipping blood pressure in COPD patients [ Time Frame: once a year ]

Other Outcome Measures:
  1. pulse wave velocity measurement [ Time Frame: once a year ]

Biospecimen Retention:   Samples With DNA
Serum samples for analysis of inflammatory and oxidative biological markers

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with exacerbated (50) or stable (195) COPD

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 neoplasia
  • 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
  • claustrophobia, patients allergic to contrast agents like Gadolinium, presence of material dissuading the realization of a MRI (pacemaker, implantable defibrillator, insulin pump, ferrometallic clips or foreign bodies in brain or eyes)

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): NCT00404430

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France : Laboratoire EFCR - Functional Cardio-Respiratory Exploration Laboratory
Grenoble, Isere, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
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Principal Investigator: Jean-Louis JP Pépin, ProfessorPhD University Hospital, Grenoble
Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University Hospital, Grenoble Identifier: NCT00404430    
Other Study ID Numbers: 0627
First Posted: November 28, 2006    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Keywords provided by University Hospital, Grenoble:
Endothelial function
Peripheral Arterial Tone
Systemic Inflammation
Oxidative Stress
Respiratory and peripheral muscular function
Cardiovascular risk
COPD severity
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Insufficiency
Respiratory Tract Diseases
Respiration Disorders