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Peripheral Endothelial Function in Asthmatic Patients (Endothasthm)

Primary Purpose

Endothelial Function

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Endopat
Sponsored by
Hopital Foch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Endothelial Function focused on measuring asthma, endothelial function

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Sites / Locations

  • Hôpital Saint Antoine, Pulmonary function test laboratory
  • Hôpital Foch Department of pneumology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

endopat

Arm Description

measure of endothelial function with endopat

Outcomes

Primary Outcome Measures

measure of reactive hyperemia-peripheral artery tone index
measure of reactive hyperemia-peripheral artery tone index

Secondary Outcome Measures

measure of the forced expiratory flow in one second (FEV1)
measure of the forced expiratory flow in one second (FEV1)
measure of the forced vital capacity (FVC)
measure of the forced vital capacity (FVC)
measure of expiratory flow between 25% and 75% (FEF25-75%)
measure of expiratory flow between 25% and 75% (FEF25-75%)

Full Information

First Posted
October 16, 2015
Last Updated
October 1, 2018
Sponsor
Hopital Foch
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1. Study Identification

Unique Protocol Identification Number
NCT02593344
Brief Title
Peripheral Endothelial Function in Asthmatic Patients
Acronym
Endothasthm
Official Title
Peripheral Endothelial Function in Asthmatic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
December 13, 2012 (Actual)
Primary Completion Date
April 9, 2015 (Actual)
Study Completion Date
April 9, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endothelial Function
Keywords
asthma, endothelial function

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
113 (Actual)

8. Arms, Groups, and Interventions

Arm Title
endopat
Arm Type
Experimental
Arm Description
measure of endothelial function with endopat
Intervention Type
Device
Intervention Name(s)
Endopat
Intervention Description
measure of peripheral endothelial function by the reactive hyperemia-peripheral artery tone index with a specific device (Endopat)
Primary Outcome Measure Information:
Title
measure of reactive hyperemia-peripheral artery tone index
Description
measure of reactive hyperemia-peripheral artery tone index
Time Frame
day 1
Secondary Outcome Measure Information:
Title
measure of the forced expiratory flow in one second (FEV1)
Description
measure of the forced expiratory flow in one second (FEV1)
Time Frame
day 1
Title
measure of the forced vital capacity (FVC)
Description
measure of the forced vital capacity (FVC)
Time Frame
day 1
Title
measure of expiratory flow between 25% and 75% (FEF25-75%)
Description
measure of expiratory flow between 25% and 75% (FEF25-75%)
Time Frame
day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Devillier, MD PhD
Organizational Affiliation
Foch hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Saint Antoine, Pulmonary function test laboratory
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Hôpital Foch Department of pneumology
City
Suresnes
ZIP/Postal Code
92150
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
6253831
Citation
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.
Results Reference
background
PubMed Identifier
3087875
Citation
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.
Results Reference
background
PubMed Identifier
3955307
Citation
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.
Results Reference
background
PubMed Identifier
21378026
Citation
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.
Results Reference
background
PubMed Identifier
9609729
Citation
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.
Results Reference
background
PubMed Identifier
16373872
Citation
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.
Results Reference
background
PubMed Identifier
17540215
Citation
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.
Results Reference
background
PubMed Identifier
18678478
Citation
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.
Results Reference
background
PubMed Identifier
12952274
Citation
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.
Results Reference
background
PubMed Identifier
9386137
Citation
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.
Results Reference
background
PubMed Identifier
1603138
Citation
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.
Results Reference
background
PubMed Identifier
15364894
Citation
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.
Results Reference
background
PubMed Identifier
16061703
Citation
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.
Results Reference
background
PubMed Identifier
15131088
Citation
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.
Results Reference
background
PubMed Identifier
16707391
Citation
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.
Results Reference
background
PubMed Identifier
11751184
Citation
Zureik M, Benetos A, Neukirch C, Courbon D, Bean K, Thomas F, Ducimetiere P. Reduced pulmonary function is associated with central arterial stiffness in men. Am J Respir Crit Care Med. 2001 Dec 15;164(12):2181-5. doi: 10.1164/ajrccm.164.12.2107137.
Results Reference
background
PubMed Identifier
11434800
Citation
Zureik M, Kauffmann F, Touboul PJ, Courbon D, Ducimetiere P. Association between peak expiratory flow and the development of carotid atherosclerotic plaques. Arch Intern Med. 2001 Jul 9;161(13):1669-76. doi: 10.1001/archinte.161.13.1669.
Results Reference
background
PubMed Identifier
22046271
Citation
Ayer JG, Belousova EG, Harmer JA, Toelle B, Celermajer DS, Marks GB. Lung function is associated with arterial stiffness in children. PLoS One. 2011;6(10):e26303. doi: 10.1371/journal.pone.0026303. Epub 2011 Oct 25.
Results Reference
background
PubMed Identifier
17045272
Citation
Onufrak S, Abramson J, Vaccarino V. Adult-onset asthma is associated with increased carotid atherosclerosis among women in the Atherosclerosis Risk in Communities (ARIC) study. Atherosclerosis. 2007 Nov;195(1):129-37. doi: 10.1016/j.atherosclerosis.2006.09.004. Epub 2006 Oct 10.
Results Reference
background
PubMed Identifier
21337909
Citation
Cakmak A, Zeyrek D, Cece H, Erel O. The relationship between carotid intima media thickness and oxidative stress in asthmatic children. Asian Pac J Allergy Immunol. 2010 Dec;28(4):256-61.
Results Reference
background
PubMed Identifier
15115168
Citation
Yildiz P, Oflaz H, Cine N, Genchallac H, Erginel-Unaltuna N, Yildiz A, Yilmaz V. Endothelial dysfunction in patients with asthma: the role of polymorphisms of ACE and endothelial NOS genes. J Asthma. 2004 Apr;41(2):159-66. doi: 10.1081/jas-120026073.
Results Reference
background
PubMed Identifier
20888432
Citation
Hazarika S, Van Scott MR, Lust RM, Wingard CJ. Pulmonary allergic reactions impair systemic vascular relaxation in ragweed sensitive mice. Vascul Pharmacol. 2010 Nov-Dec;53(5-6):258-63. doi: 10.1016/j.vph.2010.09.005. Epub 2010 Oct 1.
Results Reference
background
PubMed Identifier
11723017
Citation
Heitzer T, Schlinzig T, Krohn K, Meinertz T, Munzel T. Endothelial dysfunction, oxidative stress, and risk of cardiovascular events in patients with coronary artery disease. Circulation. 2001 Nov 27;104(22):2673-8. doi: 10.1161/hc4601.099485. Erratum In: Circulation. 2003 Jul 29;108(4):500.
Results Reference
background
PubMed Identifier
10704159
Citation
Suwaidi JA, Hamasaki S, Higano ST, Nishimura RA, Holmes DR Jr, Lerman A. Long-term follow-up of patients with mild coronary artery disease and endothelial dysfunction. Circulation. 2000 Mar 7;101(9):948-54. doi: 10.1161/01.cir.101.9.948.
Results Reference
background
PubMed Identifier
1359209
Citation
Celermajer DS, Sorensen KE, Gooch VM, Spiegelhalter DJ, Miller OI, Sullivan ID, Lloyd JK, Deanfield JE. Non-invasive detection of endothelial dysfunction in children and adults at risk of atherosclerosis. Lancet. 1992 Nov 7;340(8828):1111-5. doi: 10.1016/0140-6736(92)93147-f.
Results Reference
background
PubMed Identifier
7649586
Citation
Asmar R, Benetos A, Topouchian J, Laurent P, Pannier B, Brisac AM, Target R, Levy BI. Assessment of arterial distensibility by automatic pulse wave velocity measurement. Validation and clinical application studies. Hypertension. 1995 Sep;26(3):485-90. doi: 10.1161/01.hyp.26.3.485.
Results Reference
background
PubMed Identifier
12142121
Citation
Hayward CS, Kraidly M, Webb CM, Collins P. Assessment of endothelial function using peripheral waveform analysis: a clinical application. J Am Coll Cardiol. 2002 Aug 7;40(3):521-8. doi: 10.1016/s0735-1097(02)01991-5.
Results Reference
background
PubMed Identifier
18458169
Citation
Hamburg NM, Keyes MJ, Larson MG, Vasan RS, Schnabel R, Pryde MM, Mitchell GF, Sheffy J, Vita JA, Benjamin EJ. Cross-sectional relations of digital vascular function to cardiovascular risk factors in the Framingham Heart Study. Circulation. 2008 May 13;117(19):2467-74. doi: 10.1161/CIRCULATIONAHA.107.748574. Epub 2008 May 5.
Results Reference
background
PubMed Identifier
22869857
Citation
Flammer AJ, Anderson T, Celermajer DS, Creager MA, Deanfield J, Ganz P, Hamburg NM, Luscher TF, Shechter M, Taddei S, Vita JA, Lerman A. The assessment of endothelial function: from research into clinical practice. Circulation. 2012 Aug 7;126(6):753-67. doi: 10.1161/CIRCULATIONAHA.112.093245.
Results Reference
background
PubMed Identifier
19217124
Citation
Selamet Tierney ES, Newburger JW, Gauvreau K, Geva J, Coogan E, Colan SD, de Ferranti SD. Endothelial pulse amplitude testing: feasibility and reproducibility in adolescents. J Pediatr. 2009 Jun;154(6):901-5. doi: 10.1016/j.jpeds.2008.12.028. Epub 2009 Feb 12.
Results Reference
background
PubMed Identifier
18483158
Citation
Dhindsa M, Sommerlad SM, DeVan AE, Barnes JN, Sugawara J, Ley O, Tanaka H. Interrelationships among noninvasive measures of postischemic macro- and microvascular reactivity. J Appl Physiol (1985). 2008 Aug;105(2):427-32. doi: 10.1152/japplphysiol.90431.2008. Epub 2008 May 15.
Results Reference
background
PubMed Identifier
12851627
Citation
Kuvin JT, Patel AR, Sliney KA, Pandian NG, Sheffy J, Schnall RP, Karas RH, Udelson JE. Assessment of peripheral vascular endothelial function with finger arterial pulse wave amplitude. Am Heart J. 2003 Jul;146(1):168-74. doi: 10.1016/S0002-8703(03)00094-2.
Results Reference
background
PubMed Identifier
16614356
Citation
Nohria A, Gerhard-Herman M, Creager MA, Hurley S, Mitra D, Ganz P. Role of nitric oxide in the regulation of digital pulse volume amplitude in humans. J Appl Physiol (1985). 2006 Aug;101(2):545-8. doi: 10.1152/japplphysiol.01285.2005. Epub 2006 Apr 13.
Results Reference
background
PubMed Identifier
15582310
Citation
Bonetti PO, Pumper GM, Higano ST, Holmes DR Jr, Kuvin JT, Lerman A. Noninvasive identification of patients with early coronary atherosclerosis by assessment of digital reactive hyperemia. J Am Coll Cardiol. 2004 Dec 7;44(11):2137-41. doi: 10.1016/j.jacc.2004.08.062.
Results Reference
background
PubMed Identifier
18346515
Citation
Mahmud FH, Van Uum S, Kanji N, Thiessen-Philbrook H, Clarson CL. Impaired endothelial function in adolescents with type 1 diabetes mellitus. J Pediatr. 2008 Apr;152(4):557-62. doi: 10.1016/j.jpeds.2007.08.044. Epub 2007 Nov 5.
Results Reference
background
PubMed Identifier
17374431
Citation
Lowenstein L, Damti A, Pillar G, Shott S, Blumenfeld Z. Evaluation of endothelial function in women with polycystic ovary syndrome. Eur J Obstet Gynecol Reprod Biol. 2007 Oct;134(2):208-12. doi: 10.1016/j.ejogrb.2007.02.011. Epub 2007 Mar 19.
Results Reference
background
PubMed Identifier
19121648
Citation
Roifman I, Sun YC, Fedwick JP, Panaccione R, Buret AG, Liu H, Rostom A, Anderson TJ, Beck PL. Evidence of endothelial dysfunction in patients with inflammatory bowel disease. Clin Gastroenterol Hepatol. 2009 Feb;7(2):175-82. doi: 10.1016/j.cgh.2008.10.021. Epub 2008 Oct 30.
Results Reference
background
PubMed Identifier
16171272
Citation
Itzhaki S, Lavie L, Pillar G, Tal G, Lavie P. Endothelial dysfunction in obstructive sleep apnea measured by peripheral arterial tone response in the finger to reactive hyperemia. Sleep. 2005 May;28(5):594-600. doi: 10.1093/sleep/28.5.594.
Results Reference
background

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Peripheral Endothelial Function in Asthmatic Patients

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