Dyspnea; AsthmaticDFUNBIONCT05903001
Diaphragmatic Function as a Biomarker
An observational study of Dyspnea; Asthmatic and COPD, run by RWTH Aachen University at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspnea; Asthmatic, COPD, Fibrosis
- What is being tested?
- Diaphragm Ultrasound, Intercostal Muscle Ultrasound and Borg scale
- How many people
- 800 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2023to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 800 patients, 4 groups
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
RWTH Aachen University Hospital
Aachen, North Rhine-Westphalia, 52074
Jens Spiesshoefer, PhD, +492418037036, jspiesshoefer@ukaachen.de
Binaya Regmi, MD, +492418037065, bregmi@ukaachen.de
About this study
Official title: Diaphragmatic Function as a Biomarker in Patients With Respiratory Diseases
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.
Read the detailed 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.
- Conditions
- Dyspnea; Asthmatic, COPD, Fibrosis, Pulmonary Hypertension, Asthma, Dyspnea
- Being tested
- Diaphragm Ultrasound, Intercostal Muscle Ultrasound, Borg scale, MRC Breathlessness Scale, Respiratory Questionaire
- Keywords
- dyspnea, COPD, asthma, fibrosis, pulmonary hypertension, pneumology
- Medical subject headings
- Dyspnea, Asthma, Pulmonary Disease, Chronic Obstructive, Fibrosis, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragm UltrasoundDiagnostic test
Ultrasound of the Diaphragm at the end of inspiration and expiration
Intercostal Muscle UltrasoundDiagnostic test
Ultrasound of the Intercostal Muscles at the end of inspiration and expiration
Borg scaleDiagnostic test
Questionnaire for Perceived Exertion (Borg Rating of Perceived Exertion Scale)
MRC Breathlessness ScaleDiagnostic test
The MRC Dyspnoea Scale allows the patients to indicate the extent to which their breathlessness affects their mobility.
Respiratory QuestionaireDiagnostic test
Specialized respiratory questionnaire with different domains (Emotional Domain, Dyspnea Domain, Mastery Domain, Fatigue Domain)
GINA classification of AsthmaDiagnostic test
Patients are classified according to the GINA classification of Asthma.
Measurement of respiratory mouth pressureDiagnostic test
Inspiratory and expiratory Measurement of respiratory mouth pressure
SNIPDiagnostic test
Measurement of Sniff Nasal Inspiratory Pressure
6-minute walking distanceDiagnostic test
The maximum walking distance achieved in 6 minutes
60 seconds sit-to-stand testDiagnostic test
number of repetitions achieved in sitting down and standing up in 60 seconds
ElectromyographyDiagnostic test
electromyography of the muscles of respiration via superficial electrodes
Lung FunctionDiagnostic test
Measurement of lung function via body plethysmography
CAT-QuestionnaireDiagnostic test
COPD Assessment Test (CAT)
European Society of Cardiology (ESC)/ European Respiratory Society (ERS) risk groupDiagnostic test
Patients with pulmonary hypertension are classified according to the ESC/ERS risk group.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Asthma | Not described Receives: Diagnostic Test: Diaphragm Ultrasound; Diagnostic Test: Intercostal Muscle Ultrasound; Diagnostic Test: Borg scale; Diagnostic Test: MRC Breathlessness Scale; Diagnostic Test: Respiratory Questionaire; Diagnostic Test: GINA classification of Asthma; Diagnostic Test: Measurement of respiratory mouth pressure; Diagnostic Test: SNIP; Diagnostic Test: 6-minute walking distance; Diagnostic Test: 60 seconds sit-to-stand test; Diagnostic Test: Electromyography; Diagnostic Test: Lung Function | |
| Patients with COPD | Not described Receives: Diagnostic Test: Diaphragm Ultrasound; Diagnostic Test: Intercostal Muscle Ultrasound; Diagnostic Test: Borg scale; Diagnostic Test: MRC Breathlessness Scale; Diagnostic Test: Respiratory Questionaire; Diagnostic Test: Measurement of respiratory mouth pressure; Diagnostic Test: SNIP; Diagnostic Test: 6-minute walking distance; Diagnostic Test: 60 seconds sit-to-stand test; Diagnostic Test: Electromyography; Diagnostic Test: Lung Function; Diagnostic Test: CAT-Questionnaire | |
| Patients with Fibrosis | Not described Receives: Diagnostic Test: Diaphragm Ultrasound; Diagnostic Test: Intercostal Muscle Ultrasound; Diagnostic Test: Borg scale; Diagnostic Test: MRC Breathlessness Scale; Diagnostic Test: Respiratory Questionaire; Diagnostic Test: Measurement of respiratory mouth pressure; Diagnostic Test: SNIP; Diagnostic Test: 6-minute walking distance; Diagnostic Test: 60 seconds sit-to-stand test; Diagnostic Test: Electromyography; Diagnostic Test: Lung Function | |
| Patients with Pulmonary Hypertension | Not described Receives: Diagnostic Test: Diaphragm Ultrasound; Diagnostic Test: Intercostal Muscle Ultrasound; Diagnostic Test: Borg scale; Diagnostic Test: MRC Breathlessness Scale; Diagnostic Test: Respiratory Questionaire; Diagnostic Test: Measurement of respiratory mouth pressure; Diagnostic Test: SNIP; Diagnostic Test: 6-minute walking distance; Diagnostic Test: 60 seconds sit-to-stand test; Diagnostic Test: Electromyography; Diagnostic Test: Lung Function; Diagnostic Test: European Society of Cardiology (ESC)/ European Respiratory Society (ERS) risk group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspnea Borg scale 1 to 10
Borg scale before and after "6 minute walking distance" test. Lower scores show fewer dyspnea, higher scores indicate more dyspnea.
Measured: 6 months recruiting
Dyspnea Borg scale 1 to 10
Borg scale before and after "6 minute walking distance" test. Lower scores show fewer dyspnea, higher scores indicate more dyspnea.
Measured: follow up 3 months after recruitment
Dyspnea Borg scale 1 to 10
Borg scale before and after "6 minute walking distance" test. Lower scores show fewer dyspnea, higher scores indicate more dyspnea.
Measured: follow up 6 months after recruitment
Dyspnea Borg scale 1 to 10
Borg scale before and after "6 minute walking distance" test. Lower scores show fewer dyspnea, higher scores indicate more dyspnea.
Measured: follow up 12 months after recruitment
Dyspnea Borg scale 1 to 10
Borg scale before and after "6 minute walking distance" test. Lower scores show fewer dyspnea, higher scores indicate more dyspnea.
Measured: follow up 18 months after recruitment
Secondary outcomes (24)
6 minute walking distance in m
Measurement of achieved walking distance in 6 minutes
Measured: 6 months recruiting
Sit-to stand-test (60 seconds)
Measurement of achieved repetitions of standing up and sitting down from an initial seated position in 60 seconds.
Measured: 6 months recruiting
New York Heart Association (NYHA) classification scale 1 to 4
Patients are linked to a NYHA degree. Lower scores show fewer dyspnea, higher scores indicate more dyspnea.
Measured: 6 months recruiting, follow up up to 18 months after last recruitment
Modified Medical Research Council (MRC) Breathlessness Scale 1 to 5
Patients are assessed and grouped according to their MRC Breathlessness Scale. Lower scores show fewer dyspnea, higher scores indicate more dyspnea.
Measured: 6 months recruiting, follow up up to 18 months after last recruitment
Chronic Respiratory Questionnaire (CRQ)
Assessments of different domains (Emotional Domain, Dyspnea Domain, Mastery Domain, Fatigue Domain) in a standardized questionnaire on a scale from 1 to 7. The scores for each question of each dimension are added together and divided by the number of completed questions in each domain. In general, higher scores mean a worse outcome and lower scores mean a better outcome.
For the dyspnea domain for example, a high score means that patients have less dyspnea, and a low score means that patients have more dyspnea.
Measured: 6 months recruiting, follow up up to 18 months after last recruitment
COPD Assessment Test (CAT-Questionnaire) from 0 to 40 points.
Patients are evaluated and placed into the corresponding groups. Lower scores show fewer dyspnea, higher scores indicate more dyspnea.
Measured: 6 months recruiting, follow up up to 18 months after last recruitment
Global Initiative for Asthma (GINA) classification
Patients are assessed and grouped as mild, moderate, or severe according to the GINA classification.
Measured: 6 months recruiting, follow up up to 18 months after last recruitment
Body Plethysmography
TLC (Total lung capacity) in percent predicted.
Measured: 6 months recruiting
Diaphragm Thickening Ratio (DTR) in percent
Via ultrasound, the diaphragm thickening ratio (DTR) was calculated as thickness at total lung capacity (TLC) divided by thickness at functional residual capacity (FRC).
Measured: 6 months recruiting
Diaphragm thickness at Total lung capacity (TLC)
Via ultrasound, the diaphragm thickness at TLC is measured at the maximum point of inspiration.
Measured: 6 months recruiting
Diaphragm thickness at functional capacity (FRC)
Via ultrasound, the diaphragm thickness at FRC is measured after a normal expiration.
Measured: 6 months recruiting
Diaphragm ultrasound sniff velocity in cm/s
Via ultrasound, the diaphragm sniff velocity was assessed during tidal breathing and following a maximum sniff.
Measured: 6 months recruiting
Intercostal Muscle ultrasound thickness at Total lung capacity (TLC) in cm
Via ultrasound, the intercostal thickness at TLC is measured at the maximum point of inspiration.
Measured: 6 months recruiting
Intercostal Muscle ultrasound thickness at functional capacity (FRC) in cm
Via ultrasound, the intercostal thickness at FRC is measured after a normal expiration.
Measured: 6 months recruiting
Intercostal Muscle Thickening Ratio in percent
Via ultrasound, the intercostal muscle thickening ratio was calculated as thickness at total lung capacity (TLC) divided by thickness at functional residual capacity (FRC).
Measured: 6 months recruiting
Maximum Inspiratory Pressure (MIP) in percent predicted
Measurement of Maximum Inspiratory Pressure
Measured: 6 months recruiting
Maximum Expiratory Pressure (MEP) in percent predicted
Measurement of Maximum Expiratory Pressure
Measured: 6 months recruiting
Sniff Nasal Inspiratory Pressure (SNIP) in percent predicted
Measurement of Sniff Nasal Inspiratory Pressure
Measured: 6 months recruiting
Blood Gas Analysis in cmH2O
oxygen partial pressure (pO2)
Measured: 6 months recruiting
Blood Gas Analysis in cmH2O
carbon dioxide partial pressure (pCO2)
Measured: 6 months recruiting
Blood Gas Analysis
pH scale
Measured: 6 months recruiting
Blood Gas Analysis in mmol/l
Base Excess
Measured: 6 months recruiting
Blood Gas Analysis in (I1/s) percent
Base Excess
Measured: 6 months recruiting
Electromyography (EMG)
Measurement of electrical activity during different breathing maneuvers (Sniff, Cough, Valsalva, Mueller) via superficial electrodes placed on the diaphragm and accessory respiratory muscles (Sternocleidomastoideus muscle, intercostal muscles).
Measured: 6 months recruiting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start1 Jul 2023
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Dyspnea; AsthmaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jens Spießhöfer, RWTH Aachen University
- Investigators
- Michael Dreher, MD, Study director, Uniklinik RWTH AachenBinaya Regmi, MD, Study chair, Uniklinik RWTH AachenJens Spiesshoefer, MD, Principal investigator, Uniklinik RWTH AachenMustafa Elfeturi, Study chair, Uniklinik RWTH AachenBenedikt Jörn, Study chair, Uniklinik RWTH AachenFaniry Ratsimba, Study chair, Uniklinik RWTH AachenFelix Wagner, Study chair, Uniklinik RWTH AachenMaria Aetou, Dr. med., Study chair, RWTH Aachen University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05903001
- Sponsor's protocol ID
- RWTHAachenU
- Acronym
- DFUNBIO
- Status last verified
- Jan 2026
- First submitted
- 18 May 2023
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Daher A, Balfanz P, Aetou M, Hartmann B, Muller-Wieland D, Muller T, Marx N, Dreher M, Cornelissen CG. Clinical course of COVID-19 patients needing supplemental oxygen outside the intensive care unit. Sci Rep. 2021 Jan 26;11(1):2256. doi: 10.1038/s41598-021-81444-9.
PubMed 33500431Daher A, Balfanz P, Cornelissen C, Muller A, Bergs I, Marx N, Muller-Wieland D, Hartmann B, Dreher M, Muller T. Follow up of patients with severe coronavirus disease 2019 (COVID-19): Pulmonary and extrapulmonary disease sequelae. Respir Med. 2020 Nov-Dec;174:106197. doi: 10.1016/j.rmed.2020.106197. Epub 2020 Oct 20.
PubMed 33120193Balfanz P, Hartmann B, Muller-Wieland D, Kleines M, Hackl D, Kossack N, Kersten A, Cornelissen C, Muller T, Daher A, Stohr R, Bickenbach J, Marx G, Marx N, Dreher M. Early risk markers for severe clinical course and fatal outcome in German patients with COVID-19. PLoS One. 2021 Jan 29;16(1):e0246182. doi: 10.1371/journal.pone.0246182. eCollection 2021.
PubMed 33513168Spiesshoefer J, Henke C, Herkenrath S, Brix T, Randerath W, Young P, Boentert M. Transdiapragmatic pressure and contractile properties of the diaphragm following magnetic stimulation. Respir Physiol Neurobiol. 2019 Aug;266:47-53. doi: 10.1016/j.resp.2019.04.011. Epub 2019 Apr 25.
PubMed 31029769Spiesshoefer J, Henke C, Herkenrath S, Randerath W, Brix T, Young P, Boentert M. Assessment of Central Drive to the Diaphragm by Twitch Interpolation: Normal Values, Theoretical Considerations, and Future Directions. Respiration. 2019;98(4):283-293. doi: 10.1159/000500726. Epub 2019 Jul 26.
PubMed 31352459Spiesshoefer J, Herkenrath S, Henke C, Langenbruch L, Schneppe M, Randerath W, Young P, Brix T, Boentert M. Evaluation of Respiratory Muscle Strength and Diaphragm Ultrasound: Normative Values, Theoretical Considerations, and Practical Recommendations. Respiration. 2020;99(5):369-381. doi: 10.1159/000506016. Epub 2020 May 12.
PubMed 32396905
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragmatic Function as a Biomarker in Patients With Respiratory Diseases
- ClinicalTrials.gov ID
- NCT05903001
- Acronym / sponsor ID
- DFUNBIO / RWTHAachenU
- Conditions
- Dyspnea; Asthmatic, COPD, Fibrosis, Pulmonary Hypertension, Asthma, Dyspnea
- Keywords
- dyspnea, COPD, asthma, fibrosis, pulmonary hypertension, pneumology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients with Asthma | – | Diagnostic Test: Diaphragm Ultrasound, Diagnostic Test: Intercostal Muscle Ultrasound, Diagnostic Test: Borg scale, Diagnostic Test: MRC Breathlessness Scale, Diagnostic Test: Respiratory Questionaire, Diagnostic Test: GINA classification of Asthma, Diagnostic Test: Measurement of respiratory mouth pressure, Diagnostic Test: SNIP, Diagnostic Test: 6-minute walking distance, Diagnostic Test: 60 seconds sit-to-stand test, Diagnostic Test: Electromyography, Diagnostic Test: Lung Function |
| Patients with COPD | – | Diagnostic Test: Diaphragm Ultrasound, Diagnostic Test: Intercostal Muscle Ultrasound, Diagnostic Test: Borg scale, Diagnostic Test: MRC Breathlessness Scale, Diagnostic Test: Respiratory Questionaire, Diagnostic Test: Measurement of respiratory mouth pressure, Diagnostic Test: SNIP, Diagnostic Test: 6-minute walking distance, Diagnostic Test: 60 seconds sit-to-stand test, Diagnostic Test: Electromyography, Diagnostic Test: Lung Function, Diagnostic Test: CAT-Questionnaire |
| Patients with Fibrosis | – | Diagnostic Test: Diaphragm Ultrasound, Diagnostic Test: Intercostal Muscle Ultrasound, Diagnostic Test: Borg scale, Diagnostic Test: MRC Breathlessness Scale, Diagnostic Test: Respiratory Questionaire, Diagnostic Test: Measurement of respiratory mouth pressure, Diagnostic Test: SNIP, Diagnostic Test: 6-minute walking distance, Diagnostic Test: 60 seconds sit-to-stand test, Diagnostic Test: Electromyography, Diagnostic Test: Lung Function |
| Patients with Pulmonary Hypertension | – | Diagnostic Test: Diaphragm Ultrasound, Diagnostic Test: Intercostal Muscle Ultrasound, Diagnostic Test: Borg scale, Diagnostic Test: MRC Breathlessness Scale, Diagnostic Test: Respiratory Questionaire, Diagnostic Test: Measurement of respiratory mouth pressure, Diagnostic Test: SNIP, Diagnostic Test: 6-minute walking distance, Diagnostic Test: 60 seconds sit-to-stand test, Diagnostic Test: Electromyography, Diagnostic Test: Lung Function, Diagnostic Test: European Society of Cardiology (ESC)/ European Respiratory Society (ERS) risk group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 800 patients, 4 groups
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diaphragm UltrasoundUltrasound of the Diaphragm at the end of inspiration and expiration | Diagnostic test | Patients with Asthma, Patients with COPD, Patients with Fibrosis, Patients with Pulmonary Hypertension |
| Intercostal Muscle UltrasoundUltrasound of the Intercostal Muscles at the end of inspiration and expiration | Diagnostic test | Patients with Asthma, Patients with COPD, Patients with Fibrosis, Patients with Pulmonary Hypertension |
| Borg scaleQuestionnaire for Perceived Exertion (Borg Rating of Perceived Exertion Scale) | Diagnostic test | Patients with Asthma, Patients with COPD, Patients with Fibrosis, Patients with Pulmonary Hypertension |
| MRC Breathlessness ScaleThe MRC Dyspnoea Scale allows the patients to indicate the extent to which their breathlessness affects their mobility. | Diagnostic test | Patients with Asthma, Patients with COPD, Patients with Fibrosis, Patients with Pulmonary Hypertension |
| Respiratory QuestionaireSpecialized respiratory questionnaire with different domains (Emotional Domain, Dyspnea Domain, Mastery Domain, Fatigue Domain) | Diagnostic test | Patients with Asthma, Patients with COPD, Patients with Fibrosis, Patients with Pulmonary Hypertension |
| GINA classification of AsthmaPatients are classified according to the GINA classification of Asthma. | Diagnostic test | Patients with Asthma |
| Measurement of respiratory mouth pressureInspiratory and expiratory Measurement of respiratory mouth pressure | Diagnostic test | Patients with Asthma, Patients with COPD, Patients with Fibrosis, Patients with Pulmonary Hypertension |
| SNIPMeasurement of Sniff Nasal Inspiratory Pressure | Diagnostic test | Patients with Asthma, Patients with COPD, Patients with Fibrosis, Patients with Pulmonary Hypertension |
| 6-minute walking distanceThe maximum walking distance achieved in 6 minutes | Diagnostic test | Patients with Asthma, Patients with COPD, Patients with Fibrosis, Patients with Pulmonary Hypertension |
| 60 seconds sit-to-stand testnumber of repetitions achieved in sitting down and standing up in 60 seconds | Diagnostic test | Patients with Asthma, Patients with COPD, Patients with Fibrosis, Patients with Pulmonary Hypertension |
| Electromyographyelectromyography of the muscles of respiration via superficial electrodes | Diagnostic test | Patients with Asthma, Patients with COPD, Patients with Fibrosis, Patients with Pulmonary Hypertension |
| Lung FunctionMeasurement of lung function via body plethysmography | Diagnostic test | Patients with Asthma, Patients with COPD, Patients with Fibrosis, Patients with Pulmonary Hypertension |
| CAT-QuestionnaireCOPD Assessment Test (CAT) | Diagnostic test | Patients with COPD |
| European Society of Cardiology (ESC)/ European Respiratory Society (ERS) risk groupPatients with pulmonary hypertension are classified according to the ESC/ERS risk group. | Diagnostic test | Patients with Pulmonary Hypertension |
Primary outcome
Dyspnea Borg scale 1 to 10
Time frame: 6 months recruiting
Borg scale before and after "6 minute walking distance" test. Lower scores show fewer dyspnea, higher scores indicate more dyspnea.
Dyspnea Borg scale 1 to 10
Time frame: follow up 3 months after recruitment
Borg scale before and after "6 minute walking distance" test. Lower scores show fewer dyspnea, higher scores indicate more dyspnea.
Dyspnea Borg scale 1 to 10
Time frame: follow up 6 months after recruitment
Borg scale before and after "6 minute walking distance" test. Lower scores show fewer dyspnea, higher scores indicate more dyspnea.
Dyspnea Borg scale 1 to 10
Time frame: follow up 12 months after recruitment
Borg scale before and after "6 minute walking distance" test. Lower scores show fewer dyspnea, higher scores indicate more dyspnea.
Dyspnea Borg scale 1 to 10
Time frame: follow up 18 months after recruitment
Borg scale before and after "6 minute walking distance" test. Lower scores show fewer dyspnea, higher scores indicate more dyspnea.
24 secondary outcomes
6 minute walking distance in m
Time frame: 6 months recruiting
Sit-to stand-test (60 seconds)
Time frame: 6 months recruiting
New York Heart Association (NYHA) classification scale 1 to 4
Time frame: 6 months recruiting, follow up up to 18 months after last recruitment
Modified Medical Research Council (MRC) Breathlessness Scale 1 to 5
Time frame: 6 months recruiting, follow up up to 18 months after last recruitment
Chronic Respiratory Questionnaire (CRQ)
Time frame: 6 months recruiting, follow up up to 18 months after last recruitment
COPD Assessment Test (CAT-Questionnaire) from 0 to 40 points.
Time frame: 6 months recruiting, follow up up to 18 months after last recruitment
Global Initiative for Asthma (GINA) classification
Time frame: 6 months recruiting, follow up up to 18 months after last recruitment
Body Plethysmography
Time frame: 6 months recruiting
Diaphragm Thickening Ratio (DTR) in percent
Time frame: 6 months recruiting
Diaphragm thickness at Total lung capacity (TLC)
Time frame: 6 months recruiting
Diaphragm thickness at functional capacity (FRC)
Time frame: 6 months recruiting
Diaphragm ultrasound sniff velocity in cm/s
Time frame: 6 months recruiting
Intercostal Muscle ultrasound thickness at Total lung capacity (TLC) in cm
Time frame: 6 months recruiting
Intercostal Muscle ultrasound thickness at functional capacity (FRC) in cm
Time frame: 6 months recruiting
Intercostal Muscle Thickening Ratio in percent
Time frame: 6 months recruiting
Maximum Inspiratory Pressure (MIP) in percent predicted
Time frame: 6 months recruiting
Maximum Expiratory Pressure (MEP) in percent predicted
Time frame: 6 months recruiting
Sniff Nasal Inspiratory Pressure (SNIP) in percent predicted
Time frame: 6 months recruiting
Blood Gas Analysis in cmH2O
Time frame: 6 months recruiting
Blood Gas Analysis in cmH2O
Time frame: 6 months recruiting
Blood Gas Analysis
Time frame: 6 months recruiting
Blood Gas Analysis in mmol/l
Time frame: 6 months recruiting
Blood Gas Analysis in (I1/s) percent
Time frame: 6 months recruiting
Electromyography (EMG)
Time frame: 6 months recruiting
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Background: PubMed 33500431Daher A, Balfanz P, Aetou M, Hartmann B, Muller-Wieland D, Muller T, Marx N, Dreher M, Cornelissen CG. Clinical course of COVID-19 patients needing supplemental oxygen outside the intensive care unit. Sci Rep. 2021 Jan 26;11(1):2256. doi: 10.1038/s41598-021-81444-9.
- Background: PubMed 33120193Daher A, Balfanz P, Cornelissen C, Muller A, Bergs I, Marx N, Muller-Wieland D, Hartmann B, Dreher M, Muller T. Follow up of patients with severe coronavirus disease 2019 (COVID-19): Pulmonary and extrapulmonary disease sequelae. Respir Med. 2020 Nov-Dec;174:106197. doi: 10.1016/j.rmed.2020.106197. Epub 2020 Oct 20.
- Background: PubMed 33513168Balfanz P, Hartmann B, Muller-Wieland D, Kleines M, Hackl D, Kossack N, Kersten A, Cornelissen C, Muller T, Daher A, Stohr R, Bickenbach J, Marx G, Marx N, Dreher M. Early risk markers for severe clinical course and fatal outcome in German patients with COVID-19. PLoS One. 2021 Jan 29;16(1):e0246182. doi: 10.1371/journal.pone.0246182. eCollection 2021.
- Background: PubMed 31029769Spiesshoefer J, Henke C, Herkenrath S, Brix T, Randerath W, Young P, Boentert M. Transdiapragmatic pressure and contractile properties of the diaphragm following magnetic stimulation. Respir Physiol Neurobiol. 2019 Aug;266:47-53. doi: 10.1016/j.resp.2019.04.011. Epub 2019 Apr 25.
- Background: PubMed 31352459Spiesshoefer J, Henke C, Herkenrath S, Randerath W, Brix T, Young P, Boentert M. Assessment of Central Drive to the Diaphragm by Twitch Interpolation: Normal Values, Theoretical Considerations, and Future Directions. Respiration. 2019;98(4):283-293. doi: 10.1159/000500726. Epub 2019 Jul 26.
- Background: PubMed 32396905Spiesshoefer J, Herkenrath S, Henke C, Langenbruch L, Schneppe M, Randerath W, Young P, Brix T, Boentert M. Evaluation of Respiratory Muscle Strength and Diaphragm Ultrasound: Normative Values, Theoretical Considerations, and Practical Recommendations. Respiration. 2020;99(5):369-381. doi: 10.1159/000506016. Epub 2020 May 12.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Dreher, MD study director
Uniklinik RWTH Aachen
Binaya Regmi, MD study chair
Uniklinik RWTH Aachen
Jens Spiesshoefer, MD principal investigator
Uniklinik RWTH Aachen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyspnea; Asthmatic and COPD, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jens Spiesshoefer, MD (0049 2418037036, jspiesshoefer@ukaachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dyspnea Borg scale 1 to 10 (time frame: 6 months recruiting). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05903001, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.