Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03197909
Other study ID # RECHMPL17_0210
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 6, 2017
Est. completion date January 31, 2019

Study information

Verified date September 2018
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date January 31, 2019
Est. primary completion date December 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 35 Years to 85 Years
Eligibility Inclusion Criteria:

35 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

Exclusion Criteria:

- A recent COPD exacerbation (< 4weeks)

- The decompensation of a comorbidity

- An antioxidant supplementation or medication

- A long-term systemic corticosteroid medication

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Determination of pro-inflammatory plasma factors
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

Locations

Country Name City State
France Uhmontpellier Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Other Level of pro-Inflamatory markers Level of pro-Inflamatory markers in the serum 6 days
Primary 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 Expression and translation of markers of Expression and translation of markers of anabolic and catabolic pathways 6 days
See also
  Status Clinical Trial Phase
Completed NCT00105183 - EZ-2053 in the Prophylaxis of Acute Pulmonary Allograft Rejection Phase 3