Clinical trial NCT02282436: Substudy : Patients With an Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Official title: Muscle Atrophy in Patients With Chronic Obstructive Pulmonary DIsease : Substudy With Patients Who Experienced an Acute Exacerbation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2014-11-04
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female who are experiencing an acute exacerbation of their COPD.

Brief summary: Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide. Its prevalence is in progression and COPD is expected to become the fourth leading cause of death by 2030. COPD is characterized by periods of stability interspersed with acute infectious/inflammatory flare-ups, also called acute exacerbations, during which patients deteriorate, sometimes to the point of requiring immediate medical assistance. Although most patients eventually recover, repeated episodes of exacerbations may accelerate COPD progression. Exacerbations may further compromise the integrity of limb muscles by promoting further loss in muscle mass and strength.

The overall objective of this substudy is to elucidate how an acute COPD exacerbation may affect limb muscles.

Detailed description: Focusing our attention during exacerbations, a period of aggravated systemic inflammation, should be more rewarding in terms of understanding the link between inflammation burst and muscle disease in COPD. We have recently acquired experimental data supporting a role for the ubiquitin proteasome pathway in the worsening of limb muscle structure and function during an acute exacerbation, providing a solid framework for this investigation. The overall objective of this proposal is to substantiate these preliminary findings and elucidate how systemic inflammation during acute COPD exacerbation may affect limb muscles. Ultimately, our research could open new therapeutic avenues to minimize the systemic consequences of an acute exacerbation.

Eligibility criteria: Inclusion Criteria:

* male and female
* COPD with an FEV1 of under 60% of predicted
* non-smoker
* between 50 and 75 years old
* experiencing an acute exacerbation of COPD (24-48 hours, before treatment)

Exclusion Criteria:

* all inflammatory disease (HIV, cancer, renal and cardiac deficiency)
* hormonal dysregulation
* inferior limb pathology
* neuromuscular pathology
* history of tobacco or alcool abuse
* oxygen dependent

Primary outcomes:
measure: Increased levels of ubiquitin proteasome pathway proteins in patients experiencing an acute exacerbation of COPD
timeFrame: during an acute exacerbation of COPD (first 24-48 hours, before treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Centre de recherche de l'Institut de cardiologie et de pneumologie de Québec
state: Quebec
Study officials:
affiliation: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
name: François Maltais, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: