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Chronic Obstructive Pulmonary DiseaseNCT00404430

Protocol Chronic Obstructive Pulmonary Disease

An observational study of Chronic Obstructive Pulmonary Disease and Acute Respiratory Failure, run by University Hospital, Grenoble at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
How many people
121 participants
Where
1 siteFrance
Study dates
11 Jan 2007to 21 Jan 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with exacerbated (50) or stable (195) COPD

Who may be able to join

  • 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
Show all 15Show fewer
  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

France1 site

  • France : Laboratoire EFCR - Functional Cardio-Respiratory Exploration Laboratory

    Grenoble, Isere, 38043

Other trials in France

About this study

Official title: Predictive Factors of Endothelial Function in Chronic Obstructive Disease Patients at the End of a Acute Exacerbation.

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.

Keywords
Endothelial function, Peripheral Arterial Tone, Systemic Inflammation, Oxidative Stress, Respiratory and peripheral muscular function, Cardiovascular risk, COPD severity
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00404430
Study groupRoleWhat they receive
Exacerbated COPD patientsPatients with exacerbated COPD
Stable COPD patientsPatients with stable COPD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. peripheral arterial tone

    Measured: once a year

Secondary outcomes (7)

  1. Muscle strength measurements

    Measured: once a year

  2. biological markers of inflammation and oxidative stress

    Measured: once a year

  3. respiratory function measurements

    Measured: once a year

  4. Determine the relationship between the RMI measurements and the cardiovascular risk

    Measured: once during the study

  5. Determine the relationship between the hospitalizations for decompensation and the initial value of endothelial function

    Measured: study time frame

  6. Determine the relationship between the RMI measurements and the COPD severity

    Measured: once during the study

  7. Determine the prevalence of nocturnal non-dipping blood pressure in COPD patients

    Measured: once a year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2006 (estimated)
  2. Study start11 Jan 2007
  3. Primary completion21 Jan 2021
  4. Study completion21 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00404430
Sponsor's protocol ID
0627
Status last verified
Jun 2022
First submitted
27 Nov 2006
Last updated
6 Jun 2022
Results posted
No
Data monitoring committee
Yes

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

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Obstructive Pulmonary Disease and Acute Respiratory Failure, run by University Hospital, Grenoble at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

peripheral arterial tone (time frame: once a year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00404430, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2022.

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