NCT03197909

Brief Summary

Chronic Obstructive Pulmonary Patients is a defined by persistent airflow limitation that is usually progressive and associated with an enhanced chronic inflammatory response in the airways and the lung to noxious particles or gases. It is associated with an atrophy of the skeletal muscle that impairs the patient's prognosis. The biological mechanisms of this muscle atrophy have not been elucidated, and the "spill-over theory" has recently emerged. Indeed, in COPD patients, the pulmonary inflammation is associated with a systemic low-grade inflammation, and the increased pro-inflamatory molelcules in the blood - which constitute the cellular micro-environement of the muscle fibre - could activate the mechanisms of the cell atrophy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 23, 2017

Completed
13 days until next milestone

Study Start

First participant enrolled

July 6, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

April 18, 2019

Status Verified

September 1, 2018

Enrollment Period

1.5 years

First QC Date

June 21, 2017

Last Update Submit

April 17, 2019

Conditions

Keywords

COPD (Chronic Obstructive Pulmonary Patients)Atrophycell cultursystemic inflammationCatabolism

Outcome Measures

Primary Outcomes (1)

  • Myotube diameter of in vitro cultured myotubes

    Myotube diameter of in vitro cultured myotubes from healthy subjects, exposed to the serum of healthy controls and COPD patients

    6 days

Secondary Outcomes (1)

  • Expression and translation of markers of

    6 days

Other Outcomes (1)

  • Level of pro-Inflamatory markers

    6 days

Study Arms (2)

Healthy subjects

Determination of pro-inflammatory plasma factors at Healthy subjects aged from 35 to 85 years old

Other: Determination of pro-inflammatory plasma factors

COPD patients

Determination of pro-inflammatory plasma factors at COPD patients aged from 35 to 85 years old

Other: Determination of pro-inflammatory plasma factors

Interventions

Determination of pro-inflammatory plasma factors at COPD patients aged from 35 to 85 years old and Healthy subjects aged from 35 to 85 years old

COPD patientsHealthy subjects

Eligibility Criteria

Age35 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chronic Obstructive Pulmonary Patients

You may qualify if:

  • to 85 years old
  • COPD patients: association of symtoms (breathlessness, cough, sputum) and chronic exposure to inhalated risk factors (like tobacco smoke) and a FEV1/VC ratio \<70% assessed by a spirometry
  • Healthy subjects: A sedentariness assessed by a Voorrips score \<9.4 and/or a report of \<150 min/week of moderate-to-vigorous physical activity

You may not qualify if:

  • A recent COPD exacerbation (\< 4weeks)
  • The decompensation of a comorbidity
  • An antioxidant supplementation or medication
  • A long-term systemic corticosteroid medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34290, France

Location

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

  • Maurice HAYOT, MD, PhD

    University Hospital, Montpellier

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2017

First Posted

June 23, 2017

Study Start

July 6, 2017

Primary Completion

December 31, 2018

Study Completion

January 31, 2019

Last Updated

April 18, 2019

Record last verified: 2018-09

Locations