Substudy : Patients With an Acute Exacerbation of Chronic Obstructive Pulmonary Disease (EXA)

Muscle Atrophy in Patients With Chronic Obstructive Pulmonary DIsease : Substudy With Patients Who Experienced an Acute Exacerbation

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: No specific intervention for this study

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.

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada, G1V 4G5
      • Recruiting
      • Centre de recherche de l'Institut de cardiologie et de pneumologie de Québec
      • Contact: Annie Dubé, PhD; Phone Number: 2673 418-656-8711; Email: annie.dube@criucpq.ulaval.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Male and female who are experiencing an acute exacerbation of their COPD.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COPD exacerbation; No specific intervention for this study	Other: No specific intervention for this study; No specific intervention for this study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Increased levels of ubiquitin proteasome pathway proteins in patients experiencing an acute exacerbation of COPD	Our view is that targeting exacerbation is likely to unravel important mechanisms linking systemic inflammatory processes to downstream consequences on remote organs such as limb muscles. Inflammatory burst observed during exacerbation may be associated with upregulation of ubiquitin proteasome pathway (Atrogin-1, MuRF-1, Nedd4, ubiquitin C, poly-Ub), the main proteolytic pathway in this tissue, and thus with the occurrence of atrophying process.	during an acute exacerbation of COPD (first 24-48 hours, before treatment)

Collaborators and Investigators

• Sponsor: Laval University
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: François Maltais, MD, PhD, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Anticipated): May 1, 2017
• Study Completion (Anticipated): May 1, 2018

Study Registration Dates

• First Submitted: October 9, 2014
• First Submitted That Met QC Criteria: October 31, 2014
• First Posted (Estimate): November 4, 2014

Study Record Updates

• Last Update Posted (Estimate): September 8, 2016
• Last Update Submitted That Met QC Criteria: September 7, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: EXA-COPD-20765