Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
113 participants
Study Classification
INTERVENTIONAL
Study Start Date
2012-12-13
Study Completion Date
2015-04-09
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Peripheral Endothelial Function in COPD Patients
NCT02593357
Chronic Obstructive Pulmonary Disease
COMPLETED
NA
Assessment of Peripheral Endothelial Function in Idiopathic Pulmonary Fibrosis
NCT02594059
Pulmonary Fibrosis
COMPLETED
NA
Bronchial Trans-epithelial Transport in Patients With Idiopathic Multiple Dilations of the Bronchi
NCT02586883
Idiopathic Dilation of the Bronchi
COMPLETED
NA
Study of the Impact of Exposure to Outdoor and Indoor Pollutants in Patients With Asthma
NCT05525169
Asthma
UNKNOWN
Exacerbations in Severe Asthma Patients: Mechanisms and Biomarkers
NCT02660853
Asthma
COMPLETED
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Endothelial Function
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
BASIC_SCIENCE
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
endopat
measure of endothelial function with endopat
Group Type
EXPERIMENTAL
Endopat
Intervention Type
DEVICE
measure of peripheral endothelial function by the reactive hyperemia-peripheral artery tone index with a specific device (Endopat)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Endopat
measure of peripheral endothelial function by the reactive hyperemia-peripheral artery tone index with a specific device (Endopat)
Intervention Type
DEVICE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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.
* 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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hopital Foch
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Philippe Devillier, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Foch hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hôpital Saint Antoine, Pulmonary function test laboratory
Paris, , France
Site Status
Hôpital Foch Department of pneumology
Suresnes, , France
Site Status
Countries
Review the countries where the study has at least one active or historical site.
France
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2012/54
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Mechanism and Dynamics of Bronchial Hyper-reactivity to Methacholine in Distal Airway on Obese Patients With Asthma
NCT03102749
COMPLETED
Assessing the Expression and the Activity of Rac1 Protein in the Airway Smooth Muscle of Asthmatic Patient
NCT03325088
COMPLETED
NA
Endothelial Dysfunction in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)
NCT01460082
COMPLETED
Study of Physiological Signals During and After COPD Exacerbations
NCT04034901
COMPLETED
NA
Non-contact Proactive Remote Monitoring of COPD Exacerbations
NCT05598983
RECRUITING
Evaluating Asthma Exacerbation-induced Changes in Lung Function With a Home-based Spirometer
NCT03705325
COMPLETED
NA
Bronchial Asthma & Its Exacerbation
NCT06331897
NOT_YET_RECRUITING
Respiratory Registry for Lung Health: a Prospective, Observational Study on Adult Patients With Asthma or COPD
NCT05826613
UNKNOWN
Protocol Chronic Obstructive Pulmonary Disease
NCT00404430
COMPLETED
Inhalation Profiling of Idiopathic Pulmonary Fibrosis (IPF) Patients
NCT02058602
COMPLETED
PHASE1
Prevalence and Reversibility of Lung Hyperinflation in Asthma
NCT01573364
COMPLETED
The Use of Home-monitoring and mHealth Systems to Predict Asthma Control and the Occurrence of Asthma Exacerbations
NCT02774772
COMPLETED
Asthma Breath Biomarker Assessment
NCT03084016
COMPLETED
Causes, Characteristics and Mechanisms of Infective Exacerbations in Subjects With Asthma and Chronic Obstructive Pulmonary Disease (COPD)
NCT00512954
COMPLETED
Long Term Follow up Investigation of Endobronchial Valves in Emphysema
NCT01580215
TERMINATED
Predicting Risk Factors for Exacerbation of Chronic Obstructive Pulmonary Disease
NCT03450603
RECRUITING
Evaluation of Novel Lung Function Parameters in Patients With Bronchial Asthma
NCT03820427
COMPLETED
Endothelial Dysfunction in Chronic Obstructive Pulmonary Disease
NCT00831220
COMPLETED
Role of Inhaler Adherence and Blood Eosinophil Count in Exacerbations of COPD
NCT05814484
UNKNOWN
Biological Determinants of Sputum Rheology in Chronic Airway Diseases
NCT04081740
COMPLETED
Biannual Review of Exhaled Air and Trends in Health Evaluation in COPD
NCT07045948
RECRUITING
NA
The Cohort Study for Asthma in China
NCT05937334
RECRUITING
Bronchial Inflammation in Patients With Bronchiolithis Obliterans
NCT01633385
COMPLETED
Changes in Microcirculation and Functional Status During Exacerbation of COPD
NCT03250000
UNKNOWN