Protocol Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00404430
• Other study ID #: 0627
• Status: Completed
• Start date: January 11, 2007
• Est. completion date: January 21, 2021

Study information

• Verified date: June 2022
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: January 21, 2021
• Est. primary completion date: January 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiratory Insufficiency

Locations

Country	Name	City	State
France	France : Laboratoire EFCR - Functional Cardio-Respiratory Exploration Laboratory	Grenoble	Isere

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (6)

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. Epub 2005 Feb 25. — View Citation

Lerman A, Zeiher AM. Endothelial function: cardiac events. Circulation. 2005 Jan 25;111(3):363-8. Review. — View Citation

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. Review. — View Citation

Malo O, Sauleda J, Busquets X, Miralles C, Agustí AG, Noguera A. [Systemic inflammation during exacerbations of chronic obstructive pulmonary disease]. Arch Bronconeumol. 2002 Apr;38(4):172-6. Spanish. — View Citation

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. Epub 2002 Oct 3. — View Citation

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. Epub 2005 Nov 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	pulse wave velocity measurement		once a year
Primary	peripheral arterial tone		once a year
Secondary	Muscle strength measurements		once a year
Secondary	biological markers of inflammation and oxidative stress		once a year
Secondary	respiratory function measurements		once a year
Secondary	Determine the relationship between the RMI measurements and the cardiovascular risk		once during the study
Secondary	Determine the relationship between the hospitalizations for decompensation and the initial value of endothelial function		study time frame
Secondary	Determine the relationship between the RMI measurements and the COPD severity		once during the study
Secondary	Determine the prevalence of nocturnal non-dipping blood pressure in COPD patients		once a year