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

NCT06229509 | Unknown

• 1 other identifier: AOI 2022 ROLLAND DEBORD
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease Severe; Dyspnea

Keywords

Cytokines; Myokines; Adipokines; Exercise; Noninvasive Ventilation; Sarcopenia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (2)

Effective noninvasive ventilation

EXPERIMENTAL

Alleviate dyspnea (lower Borg Score by 2 points)

Device: Effective noninvasive ventilation

Sham noninvasive ventilation

SHAM COMPARATOR

Device: Sham noninvasive ventilation

Interventions

Effective noninvasive ventilation DEVICE

Noninvasive ventilation set to alleviate dyspnea Inspiratory aid set according to a preliminary test (aiming for a diminution of 2 points in Borg score)

Effective noninvasive ventilation

Sham noninvasive ventilation DEVICE

Noninvasive ventilation set with an insufficient inspiratory aid to alleviate dyspnea

Sham noninvasive ventilation

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

MeSH Terms

Conditions

Dyspnea; Motor Activity; Sarcopenia

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical

Central Study Contacts

Lise Laclautre

CONTACT

0473751195; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: January 29, 2024
• Study Start: February 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)