Study of the Cytokine Response During Exercise Dyspnea in Patients With Chronic Obstructive Pulmonary Disease (COPD). Effect of Body Composition (CYTODINE)

Study of Cytokine Response During Exercise Dyspnea in Patients With Chronic Obstructive Pulmonary Disease (COPD). Effect of Body Composition

Dyspnea, more commonly known as breathlessness, is a symptom found in the majority of patients with chronic obstructive pulmonary disease (COPD), with a major impact on quality of life and mortality.

COPD is a chronic inflammatory disease of the bronchi, affecting 8% of the French population (more than 3 million people). By 2030, it will be the third leading cause of death worldwide. Effective management of dyspnea in these patients is a priority.

In patients with severe COPD, physical exertion increases the workload of breathing, leading to dyspnea. At the same time, the respiratory muscles and fatty cells release cytokines, myokines and adipokines - a group of proteins involved in the inflammatory response. In addition, 15% of COPD patients suffer from sarcopenia (loss of muscle mass and strength) which increases respiratory effort and dyspnea.

Our research project aims to study the effect of dyspnea relief in COPD patients on cytokine, myokine and adipokine levels, taking into account the presence of sarcopenia. Indeed, it is possible to alleviate the workload of the respiratory muscles during exercise by means of respiratory assistance.

The ultimate goal is a better understanding of dyspnea mechanisms, to enable the development of cytokine-targeted therapies and improve quality of life and survival in these patients.

Study Overview

• Status: Not yet recruiting
• Conditions: Dyspnea; Chronic Obstructive Pulmonary Disease Severe
• Intervention / Treatment: Device: Effective noninvasive ventilation; Device: Sham noninvasive ventilation

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lise Laclautre; Phone Number: 0473751195; Email: promo_interne_drci@chu-clermontferrand.fr

Study Locations

• France
  • Clermont-Ferrand, France
    • Chu Clermont-Ferrand
    • Principal Investigator: Camille ROLLAND-DEBORD
    • Contact: Lise Laclautre; Phone Number: 0473751195; Email: promo_interne_drci@chu-clermontferrand.fr
    • Sub-Investigator: Frederic COSTES

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 years
• Patient affiliated to a social security scheme.
• Patient capable of giving free, informed, written and signed consent.
• Male gender
• Severe COPD (Chronic Obstructive Pulmonary Disease) diagnosed according to GOLD criteria, in a stable state, with a forced expiratory volume (FEV1) from 30 to 50% of the predicted value (measured within one year during respiratory function tests (RFT)
• History of smoking >10 pack-years with cessation of smoking for more than 12 months.
• Patient judged by the investigator to be able to tolerate inspiratory pressure during a preliminary cycling exercise test.

Exclusion Criteria:

• Severe anxiety disorders, assessed by the STAY Y-B form questionnaire; a score above 65 indicates very high day-to-day anxiety.
• Patient under guardianship/trusteeship/supervision of justice
• Chronic hypercapnia at rest (CO2 arterial pressure ≥ 50mmHg)
• Chronic use of non-invasive ventilation
• Known pulmonary hypertension
• Chronic administration of oral corticosteroids
• Unstable heart disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Effective noninvasive ventilation; Alleviate dyspnea (lower Borg Score by 2 points)	Device: Effective noninvasive ventilation; Noninvasive ventilation set to alleviate dyspnea Inspiratory aid set according to a preliminary test (aiming for a diminution of 2 points in Borg score)
Sham Comparator: Sham noninvasive ventilation	Device: Sham noninvasive ventilation; Noninvasive ventilation set with an insufficient inspiratory aid to alleviate dyspnea

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Variation in exercise-induced release of cytokines IL-1, IL-6, IL-8, IL-10 and TNF-alpha plasma concentrations (pg/mL) between the two ventilatory conditions (sham and effective)	At rest = baseline / right after the end of exercice / 45 minutes after the end of exercice
Variation in exercise-induced release of adipokines adiponectin and leptin concentrations (pg/mL) between the two ventilatory conditions (sham and effective)	At rest = baseline / right after the end of exercice / 45 minutes after the end of exercice

Secondary Outcome Measures

Outcome Measure	Time Frame
For each ventilatory condition, study of correlation between dyspnea descriptors (Borg scale score, Multidimensional Dyspnea Profil score) and cytokines, adipokines and myokines plasma concentrations (pg/mL)	At rest = baseline / right after the end of exercice / 45 minutes after the end of exercice
For each ventilatory condition, study of correlation between muscle mass (kg) and cytokines, adipokines and myokines plasma concentrations (pg/mL).	At rest = baseline / right after the end of exercice / 45 minutes after the end of exercice
For each ventilatory condition, study of correlation between fat mass (kg) and cytokines, adipokines and myokines plasma concentrations (pg/mL).	At rest = baseline / right after the end of exercice / 45 minutes after the end of exercice

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: January 9, 2024
• First Submitted That Met QC Criteria: January 19, 2024
• First Posted (Estimated): January 29, 2024

Study Record Updates

• Last Update Posted (Estimated): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 19, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Exercise; Adipokines; Sarcopenia; Cytokines; Noninvasive Ventilation; Myokines
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Disease Attributes; Signs and Symptoms, Respiratory; Chronic Disease; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Dyspnea
• Other Study ID Numbers: AOI 2022 ROLLAND DEBORD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No