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

NCT ID: NCT06229509

Last Updated: 2024-01-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-29
• Study Completion Date: 2024-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Effective noninvasive ventilation

Alleviate dyspnea (lower Borg Score by 2 points)

Group Type: EXPERIMENTAL

Effective noninvasive ventilation

Intervention Type: 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)

Sham noninvasive ventilation

Group Type: SHAM_COMPARATOR

Sham noninvasive ventilation

Intervention Type: DEVICE

Noninvasive ventilation set with an insufficient inspiratory aid to alleviate dyspnea

Interventions

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)

Intervention Type: DEVICE

Sham noninvasive ventilation

Noninvasive ventilation set with an insufficient inspiratory aid to alleviate dyspnea

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Clermont-Ferrand

Clermont-Ferrand, , France

Countries

France

Central Contacts

Lise Laclautre

Role: CONTACT

promo_interne_drci@chu-clermontferrand.fr

0473751195

Facility Contacts

Lise Laclautre

Role: primary

promo_interne_drci@chu-clermontferrand.fr

0473751195

Other Identifiers

AOI 2022 ROLLAND DEBORD

Identifier Type: -

Identifier Source: org_study_id