NCT02284932

Brief Summary

Limb muscle dysfunction, characterized by atrophy and weakness, is amongst the most troublesome systemic consequences of chronic obstructive pulmonary disease (COPD) leading to poor functional status and premature mortality. One prevailing hypothesis stipulates that the deterioration in muscle structure and function during COPD results from a spillover of inflammatory mediators from the lungs to the systemic circulation and then to the muscles.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2014

Completed
29 days until next milestone

First Posted

Study publicly available on registry

November 6, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

September 8, 2016

Status Verified

September 1, 2016

Enrollment Period

6 years

First QC Date

October 8, 2014

Last Update Submit

September 7, 2016

Conditions

Keywords

COPDatrophymuscle

Outcome Measures

Primary Outcomes (1)

  • Decrease of protein degradation in muscles of wasted COPD patients

    At baseline (COPD in a stable state of the disease)

Secondary Outcomes (1)

  • Increase of protein synthesis in muscles of wasted COPD patients

    At baseline (COPD in a stable state of the disease)

Study Arms (2)

COPD patients

Group : COPD patients No specific intervention for this study

Other: No specific intervention for this study

Healthy controls

Group : healthy volunteers No specific intervention for this study

Other: No specific intervention for this study

Interventions

No specific intervention for this study

COPD patientsHealthy controls

Eligibility Criteria

Age55 Years - 75 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with COPD

You may qualify if:

  • male
  • COPD with an FEV1 of under 60% of predicted
  • non-smoker
  • between 55 and 75 years old

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
  • recent exacerbation (2 months) of the symptoms of COPD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Québec, Quebec, G1V 4G5, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample and muscle biopsy of vastus lateralis (quadriceps)

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveAtrophy

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPathological Conditions, Anatomical

Study Officials

  • François Maltais, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professionelle de recherche

Study Record Dates

First Submitted

October 8, 2014

First Posted

November 6, 2014

Study Start

September 1, 2011

Primary Completion

September 1, 2017

Study Completion

September 1, 2018

Last Updated

September 8, 2016

Record last verified: 2016-09

Locations