AzTrials
AzTrials

Endothelial FunctionEndothasthmNCT02593344

Peripheral Endothelial Function in Asthmatic Patients

A study testing Endopat in people with Endothelial Function, 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 asthmatic patients and the relationship between the peripheral endothelial function and the pulmonary function. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Endothelial Function
What is being tested?
Endopat
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
113 participants
Where
2 sitesFrance
Study dates
13 Dec 2012to 9 Apr 2015
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All patients must have a clear-cut history of asthma at the time of enrolment into the trial (eventually confirmed in the past and documented by an increased hyperresponsiveness to methacholine; or a bronchodilator reversibility to a beta-2-adrenergic drug).

Who cannot join

  • Patients with unstable asthma
  • Patients with a significant acute disease other than asthma. A significant disease is defined as a disease which, in the opinion of the investigator, may influence the results of the trial.
  • Pregnant or nursing women.

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • Hôpital Saint Antoine, Pulmonary function test laboratory

    Paris, 75012

  • Hôpital Foch Department of pneumology

    Suresnes, 92150

Other trials in France

About this study

The aim of the study is to assess the peripheral endothelial function in adult asthmatic 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, 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 level of asthma control (Asthma Control Test (ACT)), the cardiovascular risk factors (SCORE INdex) and the treatment for asthma (controllers) will be also assessed.

Being tested
Endopat
Keywords
asthma, endothelial function
Medical subject headings
Asthma

What participants receive

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

  • EndopatDevice

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

Study groups in NCT02593344
Study groupRoleWhat they receive
endopatExperimentalmeasure of endothelial function with endopat
Receives: Device: Endopat

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 the forced expiratory flow in one second (FEV1)

    measure of the forced expiratory flow in one second (FEV1)

    Measured: day 1

  2. measure of the forced vital capacity (FVC)

    measure of the forced vital capacity (FVC)

    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 start13 Dec 2012
  3. Primary completion9 Apr 2015
  4. Study completion9 Apr 2015

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
113 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02593344
Sponsor's protocol ID
2012/54
Acronym
Endothasthm
Status last verified
Oct 2018
First submitted
16 Oct 2015
Last updated
3 Oct 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
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

  • 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

  • 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

  • Dorfmuller P, Perros F, Balabanian K, Humbert M. Inflammation in pulmonary arterial hypertension. Eur Respir J. 2003 Aug;22(2):358-63. doi: 10.1183/09031936.03.00038903.

    PubMed 12952274

  • Friedman R, Mears JG, Barst RJ. Continuous infusion of prostacyclin normalizes plasma markers of endothelial cell injury and platelet aggregation in primary pulmonary hypertension. Circulation. 1997 Nov 4;96(9):2782-4. doi: 10.1161/01.cir.96.9.2782.

    PubMed 9386137

  • Christman BW, McPherson CD, Newman JH, King GA, Bernard GR, Groves BM, Loyd JE. An imbalance between the excretion of thromboxane and prostacyclin metabolites in pulmonary hypertension. N Engl J Med. 1992 Jul 9;327(2):70-5. doi: 10.1056/NEJM199207093270202.

    PubMed 1603138

  • Xu W, Kaneko FT, Zheng S, Comhair SA, Janocha AJ, Goggans T, Thunnissen FB, Farver C, Hazen SL, Jennings C, Dweik RA, Arroliga AC, Erzurum SC. Increased arginase II and decreased NO synthesis in endothelial cells of patients with pulmonary arterial hypertension. FASEB J. 2004 Nov;18(14):1746-8. doi: 10.1096/fj.04-2317fje. Epub 2004 Sep 13.

    PubMed 15364894

  • Schanen JG, Iribarren C, Shahar E, Punjabi NM, Rich SS, Sorlie PD, Folsom AR. Asthma and incident cardiovascular disease: the Atherosclerosis Risk in Communities Study. Thorax. 2005 Aug;60(8):633-8. doi: 10.1136/thx.2004.026484.

    PubMed 16061703

  • Iribarren C, Tolstykh IV, Eisner MD. Are patients with asthma at increased risk of coronary heart disease? Int J Epidemiol. 2004 Aug;33(4):743-8. doi: 10.1093/ije/dyh081. Epub 2004 May 6.

    PubMed 15131088

  • Takemura M, Matsumoto H, Niimi A, Ueda T, Matsuoka H, Yamaguchi M, Jinnai M, Muro S, Hirai T, Ito Y, Nakamura T, Mio T, Chin K, Mishima M. High sensitivity C-reactive protein in asthma. Eur Respir J. 2006 May;27(5):908-12. doi: 10.1183/09031936.06.00114405.

    PubMed 16707391

Questions about this trial

What is this clinical trial studying?

A study testing Endopat in people with Endothelial Function, 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 1 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 NCT02593344, which also lists 38 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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