ClinicalTrials.Veeva

Menu

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

U

University Hospital, Clermont-Ferrand

Status

Not yet enrolling

Conditions

Dyspnea
Chronic Obstructive Pulmonary Disease Severe

Treatments

Device: Effective noninvasive ventilation
Device: Sham noninvasive ventilation

Study type

Interventional

Funder types

Other

Identifiers

NCT06229509
AOI 2022 ROLLAND DEBORD

Details and patient eligibility

About

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.

Enrollment

26 estimated patients

Sex

Male

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

26 participants in 2 patient groups

Effective noninvasive ventilation
Experimental group
Description:
Alleviate dyspnea (lower Borg Score by 2 points)
Treatment:
Device: Effective noninvasive ventilation
Sham noninvasive ventilation
Sham Comparator group
Treatment:
Device: Sham noninvasive ventilation

Trial contacts and locations

1

Loading...

Central trial contact

Lise Laclautre

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems