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Chronic Obstructive Pulmonary DiseaseendothBPCONCT02593357

Peripheral Endothelial Function in COPD Patients

A study testing COPD patients in people with Chronic Obstructive Pulmonary Disease, run by Hopital Foch at 2 sites 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 aim of the study is to assess the peripheral endothelial function in adult COPD (chronic obstructive pulmonary disease) patients and the relationship between the peripheral endothelial function and the pulmonary function. Read more about this study

Who is it for?
Ages 40 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Chronic Obstructive Pulmonary Disease
What is being tested?
COPD patients
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
137 participants
Where
2 sitesFrance
Study dates
17 Dec 2012to 17 Aug 2017
Phase
Interventional
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 40 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • COPD : FEV1/FVC < 70%
  • Smokers or ex-smokers ( ≥ 10 pack-years)
  • No COPD exacerbation in the last three months
  • No history of asthma and no respiratory allergy

Who cannot join

  • Pregnant or nursing women
  • Treatment with pulmonary vasodilators
  • Patients with a significant acute disease. A significant disease is defined as a disease which, in the opinion of the investigator, may influence the results of the trial.

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • Hôpital Saint-Antoine

    Paris, 75012

  • Hôpital Foch

    Suresnes, 92150

Other trials in France

About this study

Official title: Assessment of a Peripheral Endothelial Dysfunction in COPD (Chronic Obstructive Pulmonary Disease)

The aim of the study is to assess the peripheral endothelial function in adult COPD (chronic obstructive pulmonary disease) patients and the relationship between the peripheral endothelial function and the pulmonary function.

Read the detailed description

The primary criteria is the peripheral endothelial function that will be assessed by the measure of flow-mediated dilation (reactive hyperemia-peripheral artery tone index). The pulmonary function will be assessed by the measures of the FEV1 (forced expiratory volume in one second), the forced vital capacity (FVC) and the expiratory flow between 25% and 75% (FEF25-75%). The relationship between these parameters of the pulmonary function and the peripheral endothelial function will be analyzed. In addition, a relationship between peripheral endothelial function and the severity of COPD (classification according to GOLD (Global Initiative for Chronic Obstructive Lung Disease) 2010 and GOLD 2011 and the COPD assessment test, the cardiovascular risk factors (SCORE INdex) and the smoker status will be also assessed.

Being tested
COPD patients
Keywords
endothelial function, COPD, pulmonary function
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.

  • COPD patientsDevice

    measure of peripheral endothelial function by the reactive hyperemia-peripheral artery tone index with a specific device (EndoPAT®)

Study groups in NCT02593357
Study groupRoleWhat they receive
COPD patientsExperimentalmeasure of endothelial function with EndoPAT® in COPD patients
Receives: Device: COPD patients

What is being measured

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

  1. measure of reactive hyperemia-peripheral artery tone index

    measure of reactive hyperemia-peripheral artery tone index

    Measured: Day 1

Secondary outcomes (3)

  1. measure of Forced expiratory flow in one second

    measure of Forced expiratory flow in one second

    Measured: day 1

  2. measure of forced vital capacity

    measure of forced vital capacity

    Measured: day 1

  3. measure of expiratory flow between 25% and 75% (FEF25-75%).

    measure of expiratory flow between 25% and 75% (FEF25-75%).

    Measured: day 1

Timeline

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

  1. First posted2 Nov 2015 (estimated)
  2. Study start17 Dec 2012
  3. Primary completion6 Jul 2017
  4. Study completion17 Aug 2017

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
137 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02593357
Sponsor's protocol ID
2012/55
Acronym
endothBPCO
Status last verified
Oct 2018
First submitted
16 Oct 2015
Last updated
3 Oct 2018
Results posted
No
Data monitoring committee
No

Publications

  • Furchgott RF, Zawadzki JV. The obligatory role of endothelial cells in the relaxation of arterial smooth muscle by acetylcholine. Nature. 1980 Nov 27;288(5789):373-6. doi: 10.1038/288373a0.

    PubMed 6253831

  • Lockette W, Otsuka Y, Carretero O. The loss of endothelium-dependent vascular relaxation in hypertension. Hypertension. 1986 Jun;8(6 Pt 2):II61-6. doi: 10.1161/01.hyp.8.6_pt_2.ii61.

    PubMed 3087875

  • Ibengwe JK, Suzuki H. Changes in mechanical responses of vascular smooth muscles to acetylcholine, noradrenaline and high-potassium solution in hypercholesterolemic rabbits. Br J Pharmacol. 1986 Feb;87(2):395-402. doi: 10.1111/j.1476-5381.1986.tb10829.x.

    PubMed 3955307

  • Santos S, Peinado VI, Ramirez J, Melgosa T, Roca J, Rodriguez-Roisin R, Barbera JA. Characterization of pulmonary vascular remodelling in smokers and patients with mild COPD. Eur Respir J. 2002 Apr;19(4):632-8. doi: 10.1183/09031936.02.00245902.

    PubMed 11998991

  • Henno P, Boitiaux JF, Douvry B, Cazes A, Levy M, Devillier P, Delclaux C, Israel-Biet D. Tobacco-associated pulmonary vascular dysfunction in smokers: role of the ET-1 pathway. Am J Physiol Lung Cell Mol Physiol. 2011 Jun;300(6):L831-9. doi: 10.1152/ajplung.00251.2010. Epub 2011 Mar 4.

    PubMed 21378026

  • Duong-Quy S, Dao P, Hua-Huy T, Guilluy C, Pacaud P, Dinh-Xuan AT. Increased Rho-kinase expression and activity and pulmonary endothelial dysfunction in smokers with normal lung function. Eur Respir J. 2011 Feb;37(2):349-55. doi: 10.1183/09031936.00056610. Epub 2010 Jun 7.

    PubMed 20530044

  • Celermajer DS, Sorensen KE, Georgakopoulos D, Bull C, Thomas O, Robinson J, Deanfield JE. Cigarette smoking is associated with dose-related and potentially reversible impairment of endothelium-dependent dilation in healthy young adults. Circulation. 1993 Nov;88(5 Pt 1):2149-55. doi: 10.1161/01.cir.88.5.2149.

    PubMed 8222109

  • Zeiher AM, Schachinger V, Minners J. Long-term cigarette smoking impairs endothelium-dependent coronary arterial vasodilator function. Circulation. 1995 Sep 1;92(5):1094-100. doi: 10.1161/01.cir.92.5.1094.

    PubMed 7648652

  • Fratta Pasini A, Albiero A, Stranieri C, Cominacini M, Pasini A, Mozzini C, Vallerio P, Cominacini L, Garbin U. Serum oxidative stress-induced repression of Nrf2 and GSH depletion: a mechanism potentially involved in endothelial dysfunction of young smokers. PLoS One. 2012;7(1):e30291. doi: 10.1371/journal.pone.0030291. Epub 2012 Jan 17.

    PubMed 22272327

  • Nana-Sinkam SP, Lee JD, Sotto-Santiago S, Stearman RS, Keith RL, Choudhury Q, Cool C, Parr J, Moore MD, Bull TM, Voelkel NF, Geraci MW. Prostacyclin prevents pulmonary endothelial cell apoptosis induced by cigarette smoke. Am J Respir Crit Care Med. 2007 Apr 1;175(7):676-85. doi: 10.1164/rccm.200605-724OC. Epub 2007 Jan 25.

    PubMed 17255567

  • Hurlimann D, Forster A, Noll G, Enseleit F, Chenevard R, Distler O, Bechir M, Spieker LE, Neidhart M, Michel BA, Gay RE, Luscher TF, Gay S, Ruschitzka F. Anti-tumor necrosis factor-alpha treatment improves endothelial function in patients with rheumatoid arthritis. Circulation. 2002 Oct 22;106(17):2184-7. doi: 10.1161/01.cir.0000037521.71373.44.

    PubMed 12390945

  • Peinado VI, Barbera JA, Ramirez J, Gomez FP, Roca J, Jover L, Gimferrer JM, Rodriguez-Roisin R. Endothelial dysfunction in pulmonary arteries of patients with mild COPD. Am J Physiol. 1998 Jun;274(6):L908-13. doi: 10.1152/ajplung.1998.274.6.L908.

    PubMed 9609729

  • Hughes R, Tong J, Oates C, Lordan J, Corris PA. Evidence for systemic endothelial dysfunction in patients and first-order relatives with pulmonary arterial hypertension. Chest. 2005 Dec;128(6 Suppl):617S. doi: 10.1378/chest.128.6_suppl.617S. No abstract available.

    PubMed 16373872

  • Wolff B, Lodziewski S, Bollmann T, Opitz CF, Ewert R. Impaired peripheral endothelial function in severe idiopathic pulmonary hypertension correlates with the pulmonary vascular response to inhaled iloprost. Am Heart J. 2007 Jun;153(6):1088.e1-7. doi: 10.1016/j.ahj.2007.03.005.

    PubMed 17540215

  • Peled N, Bendayan D, Shitrit D, Fox B, Yehoshua L, Kramer MR. Peripheral endothelial dysfunction in patients with pulmonary arterial hypertension. Respir Med. 2008 Dec;102(12):1791-6. doi: 10.1016/j.rmed.2008.06.014. Epub 2008 Aug 3.

    PubMed 18678478

Questions about this trial

What is this clinical trial studying?

A study testing COPD patients in people with Chronic Obstructive Pulmonary Disease, run by Hopital Foch at 2 sites 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 4 inclusion and 3 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 3 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

measure of reactive hyperemia-peripheral artery tone index (time frame: Day 1). 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 NCT02593357, which also lists 50 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 3 Oct 2018.

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