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

Chronic Obstructive Pulmonary Disease Clinical Trial

— EXA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02282436
• Other study ID #: EXA-COPD-20765
• Status: Recruiting
• Phase: N/A
• First received: October 9, 2014
• Last updated: September 7, 2016
• Start date: May 2012
• Est. completion date: May 2018

Study information

• Verified date: September 2016
• Source: Laval University
• Contact: Annie Dubé, PhD
• Phone: 418-656-8711
• Email: annie.dube[@]criucpq.ulaval.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 2018
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• No specific intervention for this study
No specific intervention for this study

Locations

Country	Name	City	State
Canada	Centre de recherche de l'Institut de cardiologie et de pneumologie de Québec	Québec	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Laval University	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No