Volatolom Variation in Severe COPD During Hospitalization for Exacerbation and After Hospitalization (VOC-BPCO-Exa)

  • STATUS
    Recruiting
  • days left to enroll
    86
  • participants needed
    40
  • sponsor
    Hopital Foch
Updated on 5 April 2021

Summary

Chronic obstructive pulmonary disease (COPD) is a public health issue due to its prevalence of 8% in the general population (although it is underestimated), particularly due to the number of severe patients suffering from chronic respiratory failure and the number of hospitalizations estimated at 100,000 each year. Total health insurance expenditure in 2017 for chronic respiratory diseases (excluding cystic fibrosis and cancers) was approximately 3.5 billion, including 1 billion for hospitalizations.

Hospitalizations are mainly related to a worsening of the disease (severe exacerbations mainly of viral and/or bacterial origin). Although the majority of exacerbations are treated on an outpatient basis with antibiotics and/or oral corticosteroids, those occurring in the most severe and often the oldest patients may require hospitalization. It should be noted that almost one out of two patients hospitalized for COPD exacerbation is re-hospitalized within six months; on the other hand, age and length of stay are the two main factors of mortality in the year following hospitalization for COPD in the Intensive Care Unit. Early detection of a worsening of the health status related to COPD could allow appropriate management and avoid at least part of the hospitalizations for exacerbation with a consequent reduction of the associated morbi-mortality.

The objective of this clinical study is to determine the evolution of the profile of volatile organic compounds (VOCs) present in the exhaled air (volatolom) in patients with severe COPD after hospitalization for exacerbation. This step should allow the identification of VOCs (modification of the volatolom) which would be associated with a severe COPD exacerbation, by comparing the volatolom at the acute phase of the exacerbation to the volatoloms during the progressive return to a stable state after hospitalization and to those of patients with a stabilized severe COPD (VOC-BPCO clinical study also sponsored by Foch Hospital)

Description

Patients with severe COPD hospitalized for severe exacerbation (40 patients, ex-smokers or smokers) will be eligible for inclusion in the study.

It is planned to participate in 4 sessions (V1 to V4) of 45 minutes duration for V1 and 30 minutes maximum for V2 to V4, separated by 4 to 6 weeks. All sessions will be carried out in the Pneumology Department of the Foch Hospital, volatolomics platform (Exhalomics).

Exhalation collection will be performed at each visit in order to perform the volatolom analysis.

Details
Condition Chronic Obstructive Pulmonary Disease Exacerbation
Treatment VOC analysis
Clinical Study IdentifierNCT04816695
SponsorHopital Foch
Last Modified on5 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with severe COPD (FEV 50% of theoretical values) hospitalized for exacerbation
COPD treated for at least one year with one (or more successive) combination of at least two inhaled drugs: either a Long-Acting Beta2-Adrenergic bronchodilator (LABA) combined with a corticosteroid (CSI), or a LABA combined with a long-acting anti-cholinergic bronchodilator (LAMA), or a triple combination LABA/LAMA/CSI
History of at least one severe COPD exacerbation (treated with antibiotics and/or oral corticosteroids) in the two years preceding the study
Ex-smokers (at least 6 months of withdrawal) or active daily smokers of more than 10 pack-years
Severe dyspnea in basal state before hospitalization (mMRC stage 2)
Age between 40 and 85 years old
Perfect understanding of the French language
Have signed a consent form
Be affiliated to a health insurance plan

Exclusion Criteria

Re-hospitalization for severe exacerbation in the 6 months preceding the study
Chronic inflammatory disease (rheumatic, etc...) treated with systemic corticosteroid therapy
Long-term oxygen therapy (exclusive ambulatory oxygen therapy is not a non-inclusion criterion)
Unstable cardiovascular pathology (right or left heart failure, coronary artery disease)
Cancer under treatment or follow-up
Pregnant women
Deprived of liberty or under guardianship
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note