CompletedNot Applicable

Protocol Chronic Obstructive Pulmonary Disease

France121 participantsStarted 2007-01-11

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

peripheral arterial tone

Timeframe: once a year

Trial details

NCT IDNCT00404430

SponsorUniversity Hospital, Grenoble

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-01-21

View on ClinicalTrials.gov More Chronic Obstructive Pulmonary Disease trials