Substudy : Patients With an Acute Exacerbation of Chronic... | NCT02282436

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

NCT02282436

Sponsor

Laval University

Status

Unknown status

Last Update Posted

Sep 8, 2016Estimated

Enrollment

20Estimated

Phase

Not provided

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

No specific intervention for this study

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2012

Primary Completion Date

May 2017Estimated

Completion Date

May 2018Estimated

First Submitted Date

Oct 9, 2014

First Submission Date that Met QC Criteria

Oct 31, 2014

First Posted Date

Nov 4, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 7, 2016

Last Update Posted Date

Sep 8, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Annie Dubé, Professionnelle de recherche, Laval UniversityPrincipal Investigator

Lead Sponsor

Laval UniversityOTHER

Collaborators

Name	Class
Canadian Institutes of Health Research (CIHR)	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
COPD exacerbation		No specific intervention for this study	Other: No specific intervention for this study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No specific intervention for this study	Other	No specific intervention for this study	COPD exacerbation

Outcomes Module

Primary Outcomes

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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Annie Dubé, PhD	Contact	418-656-8711	2673	annie.dube@criucpq.ulaval.ca

Overall Officials

Name	Affiliation	Role
François Maltais, MD, PhD	Institut universitaire de cardiologie et de pneumologie de Québec, University Laval	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre de recherche de l'Institut de cardiologie et de pneumologie de Québec	Recruiting	Québec	Quebec	G1V 4G5	Canada

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided