Diaphragmatic Function as a Biomarker (DFUNBIO)

RWTH Aachen University

Status: Enrolling

Conditions: Dyspnea; Asthmatic; Asthma; Dyspnea; COPD; Fibrosis; Pulmonary Hypertension

Treatments: Diagnostic Test: European Society of Cardiology (ESC)/ European Respiratory Society (ERS) risk group; Diagnostic Test: Respiratory Questionaire; Diagnostic Test: CAT-Questionnaire; Diagnostic Test: 6-minute walking distance; Diagnostic Test: Intercostal Muscle Ultrasound; Diagnostic Test: Measurement of respiratory mouth pressure; Diagnostic Test: Electromyography; Diagnostic Test: MRC Breathlessness Scale; Diagnostic Test: 60 seconds sit-to-stand test; Diagnostic Test: SNIP; Diagnostic Test: GINA classification of Asthma; Diagnostic Test: Borg scale; Diagnostic Test: Lung Function; Diagnostic Test: Diaphragm Ultrasound

Study type: Observational

Funder types: Other

Identifiers

NCT05903001

RWTHAachenU

Details and patient eligibility

About

Dyspnea is among the most common symptoms in patients with respiratory diseases such as Asthma, chronic obstructive pulmonary disease (COPD), Fibrosis, and Pulmonary Hypertension. However, the pathophysiology and underlying mechanisms of dyspnea in patients with respiratory diseases are still poorly understood. Diaphragm dysfunction might be highly prevalent in patients with dyspnea and respiratory diseases. The association of diaphragm function and potential prognostic significance in patients with respiratory diseases has not yet been investigated.

Full description

The aim of the present project is to comprehensively measure respiratory muscle function and strength in patients with respiratory diseases. The investigators attempt to recruit 800 patients across four disease groups (Asthma, COPD, Fibrosis, and Pulmonary Hypertension) and the investigators intend to measure diaphragm and accessory respiratory muscle function and strength, lung function, and exercise tolerance, as well as the participants' symptom burden during one day at baseline in the investigators' lab. Thereafter, the investigators will follow up on patients by phone 3 months, 6 months, 12 months and 18 months after the investigators have seen them in the investigators' lab. In a small subset of patients (50 overall at most) and in those in whom a recently approved drug based therapy has been initiated (i.e. Sotatercept in PH, Nintedanib in ILD, Brensocatib in Bronchiectasis, Dupilumab in COPD, Anti IL-4/IL 13 or Anti IL 5 antibodies in eosinophilic asthma) follow up will not be by phone only but also in person to repeat the above mentioned non-invasive measurements. Based on these results, not only the association between dyspnea exercise tolerance and diaphragm function in patients with respiratory diseases can be assessed, but also the prognostic significance of diaphragm dysfunction in these patients can be determined. As such, hospitalization and exacerbation requiring the intake of steroids will be assessed and followed up on by phone, and therefore the prognostic significance of diaphragm dysfunction in predicting hospitalization and the intake of steroids can be determined.

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patient has one of the following lung diseases: COPD, bronchial asthma, pulmonary fibrosis, pulmonary hypertension
• is 18 years or older
• is mentally and physically able to understand the study and to follow instructions
• are legally competent
• signed declaration of consent

Exclusion criteria

• BMI > 35
• current or treatments or diseases in the past which could influence the evaluation of the study
• Expected lack of willingness to actively participate in study-related measures
• alcohol or drug abuse
• disc herniation/prolapse
• epilepsy
• wheelchair bound
• in custody due to an official or court order
• in a dependent relationship or employment relationship with investigating physician or one of their deputy
• emergency inpatient hospital stay within 4 weeks before study-specific examinations

Trial design

800 participants in 4 patient groups

Patients with Asthma

Treatment:

Diagnostic Test: Diaphragm Ultrasound

Diagnostic Test: Lung Function

Diagnostic Test: Borg scale

Diagnostic Test: GINA classification of Asthma

Diagnostic Test: SNIP

Diagnostic Test: 60 seconds sit-to-stand test

Diagnostic Test: Electromyography

Diagnostic Test: MRC Breathlessness Scale

Diagnostic Test: Measurement of respiratory mouth pressure

Diagnostic Test: Intercostal Muscle Ultrasound

Diagnostic Test: 6-minute walking distance

Diagnostic Test: Respiratory Questionaire

Patients with COPD

Treatment:

Diagnostic Test: Diaphragm Ultrasound

Diagnostic Test: Lung Function

Diagnostic Test: Borg scale

Diagnostic Test: SNIP

Diagnostic Test: 60 seconds sit-to-stand test

Diagnostic Test: Electromyography

Diagnostic Test: MRC Breathlessness Scale

Diagnostic Test: Measurement of respiratory mouth pressure

Diagnostic Test: Intercostal Muscle Ultrasound

Diagnostic Test: 6-minute walking distance

Diagnostic Test: CAT-Questionnaire

Diagnostic Test: Respiratory Questionaire

Patients with Fibrosis

Treatment:

Diagnostic Test: Diaphragm Ultrasound

Diagnostic Test: Lung Function

Diagnostic Test: Borg scale

Diagnostic Test: SNIP

Diagnostic Test: 60 seconds sit-to-stand test

Diagnostic Test: Electromyography

Diagnostic Test: MRC Breathlessness Scale

Diagnostic Test: Measurement of respiratory mouth pressure

Diagnostic Test: Intercostal Muscle Ultrasound

Diagnostic Test: 6-minute walking distance

Diagnostic Test: Respiratory Questionaire

Patients with Pulmonary Hypertension

Treatment:

Diagnostic Test: Diaphragm Ultrasound

Diagnostic Test: Lung Function

Diagnostic Test: Borg scale

Diagnostic Test: SNIP

Diagnostic Test: 60 seconds sit-to-stand test

Diagnostic Test: Electromyography

Diagnostic Test: MRC Breathlessness Scale

Diagnostic Test: Measurement of respiratory mouth pressure

Diagnostic Test: Intercostal Muscle Ultrasound

Diagnostic Test: 6-minute walking distance

Diagnostic Test: Respiratory Questionaire

Diagnostic Test: European Society of Cardiology (ESC)/ European Respiratory Society (ERS) risk group