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

NCT02282436 | Unknown DMC

• 1 other identifier: EXA-COPD-20765
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

COPD exacerbation

No specific intervention for this study

Other: No specific intervention for this study

Interventions

No specific intervention for this study OTHER

No specific intervention for this study

COPD exacerbation

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Laval University: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Centre de recherche de l'Institut de cardiologie et de pneumologie de Québec

Québec, Quebec, G1V 4G5, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample and muscle biopsy of vastus lateralis (quadriceps)

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• François Maltais, MD, PhD

  Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annie Dubé, PhD

CONTACT

418-656-8711; annie.dube@criucpq.ulaval.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professionnelle de recherche

Study Record Dates

• First Submitted: October 9, 2014
• First Posted: November 4, 2014
• Study Start: May 1, 2012
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2018
• Last Updated: September 8, 2016

Record last verified: 2016-09

Locations

CA (1)