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CompletedNCT00404430Updated Jun 6, 2022

Protocol Chronic Obstructive Pulmonary Disease

An observational study in Chronic Obstructive Pulmonary Disease and Acute Respiratory Failure, sponsored by University Hospital, Grenoble. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-06.

Sponsored by University Hospital, Grenoble · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
121
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease
  • Acute Respiratory Failure

Keywords

  • Endothelial function
  • Peripheral Arterial Tone
  • Systemic Inflammation
  • Oxidative Stress
  • Respiratory and peripheral muscular function
  • Cardiovascular risk
  • COPD severity
03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 121 is below the median of 157 across 929 observational studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
121 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • Exacerbated COPD patients

    Patients with exacerbated COPD

  • Stable COPD patients

    Patients with stable COPD

06

What researchers measure

Primary outcomes

  1. peripheral arterial tone

    Time frame: once a year

Secondary outcomes

  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 outcomes

  1. pulse wave velocity measurement

    Time frame: once a year

07

Study locations

1 site
  • France : Laboratoire EFCR - Functional Cardio-Respiratory Exploration Laboratory
    Grenoble, Isere 38043, France
08

References and documents

Publications

  • Malo O, Sauleda J, Busquets X, Miralles C, Agusti AG, Noguera A. [Systemic inflammation during exacerbations of chronic obstructive pulmonary disease]. Arch Bronconeumol. 2002 Apr;38(4):172-6. Spanish. PubMed 11953269 ↗
  • Vassilakopoulos T, Katsaounou P, Karatza MH, Kollintza A, Zakynthinos S, Roussos C. Strenuous resistive breathing induces plasma cytokines: role of antioxidants and monocytes. Am J Respir Crit Care Med. 2002 Dec 15;166(12 Pt 1):1572-8. doi: 10.1164/rccm.200203-177OC. Epub 2002 Oct 3. PubMed 12406849 ↗
  • Yende S, Waterer GW, Tolley EA, Newman AB, Bauer DC, Taaffe DR, Jensen R, Crapo R, Rubin S, Nevitt M, Simonsick EM, Satterfield S, Harris T, Kritchevsky SB. Inflammatory markers are associated with ventilatory limitation and muscle dysfunction in obstructive lung disease in well functioning elderly subjects. Thorax. 2006 Jan;61(1):10-6. doi: 10.1136/thx.2004.034181. Epub 2005 Nov 11. PubMed 16284220 ↗
  • Barreiro E, de la Puente B, Minguella J, Corominas JM, Serrano S, Hussain SN, Gea J. Oxidative stress and respiratory muscle dysfunction in severe chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2005 May 15;171(10):1116-24. doi: 10.1164/rccm.200407-887OC. Epub 2005 Feb 25. PubMed 15735057 ↗
  • Lerman A, Zeiher AM. Endothelial function: cardiac events. Circulation. 2005 Jan 25;111(3):363-8. doi: 10.1161/01.CIR.0000153339.27064.14. No abstract available. PubMed 15668353 ↗
  • Mallia P, Johnston SL. Mechanisms and experimental models of chronic obstructive pulmonary disease exacerbations. Proc Am Thorac Soc. 2005;2(4):361-6; discussion 371-2. doi: 10.1513/pats.200504-025SR. PubMed 16267363 ↗
  • Minet C, Vivodtzev I, Tamisier R, Arbib F, Wuyam B, Timsit JF, Monneret D, Borel JC, Baguet JP, Levy P, Pepin JL. Reduced six-minute walking distance, high fat-free-mass index and hypercapnia are associated with endothelial dysfunction in COPD. Respir Physiol Neurobiol. 2012 Aug 15;183(2):128-34. doi: 10.1016/j.resp.2012.06.017. Epub 2012 Jun 18. PubMed 22721944 ↗
  • Vivodtzev I, Minet C, Wuyam B, Borel JC, Vottero G, Monneret D, Baguet JP, Levy P, Pepin JL. Significant improvement in arterial stiffness after endurance training in patients with COPD. Chest. 2010 Mar;137(3):585-92. doi: 10.1378/chest.09-1437. Epub 2009 Oct 31. PubMed 19880908 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00404430
Lead sponsor
University Hospital, Grenoble
Responsible party
Sponsor
First posted
Nov 28, 2006
Start date
Jan 11, 2007
Primary completion
Jan 21, 2021
Completion
Jan 21, 2021
Last update
Jun 6, 2022

Study contacts

Jean-Louis JP Pépin, ProfessorPhD
principal investigator · University Hospital, Grenoble

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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