Pulmonary Disease, Chronic ObstructiveNCT03500822
Effects of Dynamic Hyperinflation on the Left-ventricular Diastolic Function in Healthy Male Subjects
A study testing Metronome-paced tachypnea and Expiratory-stenosis breathing in people with Pulmonary Disease, Chronic Obstructive, run by Otto Wagner Hospital at 1 site in Austria.
Trial summary
The aim of this study is to identify whether actively induced dynamic hyperinflation can cause left-ventricular diastolic dysfunction in healthy male subjects in order to explore the mechanisms of developing cardiac dysfunctions in patients with COPD. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Metronome-paced tachypnea and Expiratory-stenosis breathing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2016to 29 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI <27 kg/m2
- Lifelong nonsmoker (currently non-smoking and up to now less than 100 cigarettes)
Who cannot join
- Obstructive pulmonary diseases (asthma, COPD)
- Cardiovascular diseases (cardiac insufficiency, coronary heart diseases, hypertonia)
- Other relevant pulmonary or cardiac diseases
- Baseline E/A-ratio <1
Trial locations and contacts
1 site in 1 country.
Austria1 site
Otto Wagner Spital, Dep. of Respiratory and Critical Care Medicine
Vienna, 1140
About this study
The aim of this study is to identify whether actively induced dynamic hyperinflation can cause left-ventricular diastolic dysfunction in healthy male subjects in order to explore the mechanisms of developing cardiac dysfunctions in patients with COPD.
Read the detailed description
Cardiovascular diseases, especially left-ventricular diastolic dysfunction, are among the most frequent reasons for morbidity and mortality in patients with chronic obstructive pulmonary disease (COPD).
Dynamic hyperinflation is one of the expected pathophysiological mechanisms in the multifactorial genesis of this left-ventricular diastolic dysfunction in patients with COPD.
The novel concept of Expiratory Stenosis Breathing (ESB) is based on the method of Metronome-Paced Tachypnea (MPT) of Cooper et al. Therefore the investigators use a metronome to indicate a specific breathing frequency (BF) and the relation of inspiration : expiration (I : E) in order to let subjects hyperinflate.
Subjects get split into two groups each hyperinflating three times for 90sec by one of the two methods before doing a cross-over and switch groups to do the same in the other group. At the end of the 90sec there is a measurement of the Inspiratory Capacity (IC) and an echocardiography in order to objectify dynamic hyperinflation respectively the change in diastolic function.
During ESB participants hyperinflate with a BF - 30/min and a I : E - 1 : 3. In addition they have to breathe through an expiratory-effective stenosis (3, 2 and 1,5mm) on the mouthpiece of the pneumotachograph to simulate the collapsing airways in COPD-patients. In contrast, during MPT subjects hyperinflate with a BF - 40/min, I : E - 1 : 1; BF - 40/min, I : E - 1 : 2; BF - 30/min, I : E - 1 : 2.
During the whole trial investigators measure Intrinsic Positive Endexpiratory Pressure (PEEPi) in order to objectify the dynamic hyperinflation more significantly.
The primary goal of this study is to assess if actively induced dynamic hyperinflation can affect diastolic function of the left ventricle.
Furthermore a correlation between the extent of dynamic hyperinflation and diastolic dysfunction should be quantified.
In addition measurement of PEEPi should validate the method of Metronome-paced Tachypnea (MPT) because the investigators hypothesize that this method does not simulate the pathophysiological circumstances in patients with COPD sufficiently.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Metronome-paced tachypnea, Expiratory-stenosis breathing
- Keywords
- dynamic hyperinflation, diastolic dysfunction, COPD, Chronic Obstructive Pulmonary Disease, Metronome-paced Tachypnea, Expiratory-stenosis Breathing
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metronome-paced tachypneaProcedure or surgery
Also called MPT
three cycles: breathing frequency (BF) - 40/min, inspiration : expiration (I : E) - 1 : 1; BF - 40/min, I : E - 1 : 2; BF - 30/min, I : E - 1 : 2
Expiratory-stenosis breathingProcedure or surgery
Also called ESB
three cycles: BF - /min, I : E - 1 : 3; stenosis: 3mm; 2mm; 1,5mm
| Study group | Role | What they receive |
|---|---|---|
| Metronome-paced tachypnea | Experimental | Dynamic hyperinflation by the method of metronome-paced tachypnea. Receives: Procedure: Metronome-paced tachypnea |
| Exspiratory-stenosis breathing | Experimental | Dynamic hyperinflation by the method of expiratory-stenosis breathing. Receives: Procedure: Expiratory-stenosis breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
E/A-ratio (absolute change between tidal breathing and smallest stenosis)
E/A-ratio will be measured by transthoracic echocardiography (Vivid S9, general electric healthcare, Fairfield, USA) according to the valid standards of The European Association of Echocardiography. This parameter represents the left-ventricular diastolic function.
Measured: At the end of each cycle - tidal breathing as well as hyperinflation-intervention (each cycle is at least 90 seconds).
Secondary outcomes (6)
E/E'-ratio
E/E'-ratio will be measured by transthoracic echocardiography (Vivid S9, general electric healthcare, Fairfield, USA) according to the valid standards of The European Association of Echocardiography. This parameter represents the left-ventricular diastolic function.
Measured: At the end of each cycle - tidal breathing as well as hyperinflation-intervention (each cycle is at least 90 seconds).
deceleration time of the E-wave transmitral (msec)
deceleration time will be measured by transthoracic echocardiography (Vivid S9, general electric healthcare, Fairfield, USA) according to the valid standards of The European Association of Echocardiography. This parameter represents the left-ventricular diastolic function.
Measured: At the end of each cycle - tidal breathing as well as hyperinflation-intervention (each cycle is at least 90 seconds).
Maximal diastolic transtricuspid flow (m/sec)
Maximal diastolic transtricuspid flow will be measured by transthoracic echocardiography (Vivid S9, general electric healthcare, Fairfield, USA) according to the valid standards of The European Association of Echocardiography. This parameter represents the left-ventricular diastolic function.
Measured: At the end of each cycle - tidal breathing as well as hyperinflation-intervention (each cycle is at least 90 seconds).
Maximal late-systolic velocity of the lateral tricuspid valve in Tissue Doppler Imaging (cm/sec)
Maximal late-systolic velocity will be measured by transthoracic echocardiography (Vivid S9, general electric healthcare, Fairfield, USA) according to the valid standards of The European Association of Echocardiography. This parameter represents the left-ventricular diastolic function.
Measured: At the end of each cycle - tidal breathing as well as hyperinflation-intervention (each cycle is at least 90 seconds).
Inspiratory Capacity
Inspiratory Capacity will be measured with a pneumotachograph (VenThor D-22/5B, ThorMedical, Budapest, Hungary). It represents the extent of dynamic hyperinflation.
Measured: At the end of each cycle - tidal breathing as well as hyperinflation-intervention (each cycle is at least 90 seconds).
Dynamic Intrinsic Positive Endexpiratory Pressure:
To objectify the dynamic hyperinflation in addition to the Inspiratory Capacity, the Intrinsic Positive Endexpiratory Pressure will be measured by the invasive application of an esophageal balloon catheter (ICU-Lab, Kleistek Engineering, Bari, Italy).
Measured: During each entire cycle - tidal breathing as well as hyperinflation-intervention (each cycle is at least 90 seconds).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study startNov 2016
- Primary completionSep 2017
- Study completion29 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otto Wagner Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georg-Christian Funk, Otto Wagner Hospital
- Investigators
- Georg C Funk, Assoc. Prof., Principal investigator, Department of Respiratory and Critical Care Medicine and Ludwig-Boltzmann Institute for COPD and Respiratory Epidemiology, Otto Wagner Hospital, Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03500822
- Sponsor's protocol ID
- Hyperstolic-COPD
- Status last verified
- Apr 2018
- First submitted
- 9 Feb 2018
- Last updated
- 18 Apr 2018
- Results posted
- No
Publications
Cooper CB, Calligaro GL, Quinn MM, Eshaghian P, Coskun F, Abrazado M, Bateman ED, Raine RI. Determinants of dynamic hyperinflation during metronome-paced tachypnea in COPD and normal subjects. Respir Physiol Neurobiol. 2014 Jan 1;190:76-80. doi: 10.1016/j.resp.2013.08.002. Epub 2013 Aug 27.
PubMed 23994176Weigt SS, Abrazado M, Kleerup EC, Tashkin DP, Cooper CB. Time course and degree of hyperinflation with metronome-paced tachypnea in COPD patients. COPD. 2008 Oct;5(5):298-304. doi: 10.1080/15412550802363428.
PubMed 18972278Evangelista A, Flachskampf F, Lancellotti P, Badano L, Aguilar R, Monaghan M, Zamorano J, Nihoyannopoulos P; European Association of Echocardiography. European Association of Echocardiography recommendations for standardization of performance, digital storage and reporting of echocardiographic studies. Eur J Echocardiogr. 2008 Jul;9(4):438-48. doi: 10.1093/ejechocard/jen174.
PubMed 18579482Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
PubMed 16055882Akoumianaki E, Maggiore SM, Valenza F, Bellani G, Jubran A, Loring SH, Pelosi P, Talmor D, Grasso S, Chiumello D, Guerin C, Patroniti N, Ranieri VM, Gattinoni L, Nava S, Terragni PP, Pesenti A, Tobin M, Mancebo J, Brochard L; PLUG Working Group (Acute Respiratory Failure Section of the European Society of Intensive Care Medicine). The application of esophageal pressure measurement in patients with respiratory failure. Am J Respir Crit Care Med. 2014 Mar 1;189(5):520-31. doi: 10.1164/rccm.201312-2193CI.
PubMed 24467647Anthonisen NR, Connett JE, Enright PL, Manfreda J; Lung Health Study Research Group. Hospitalizations and mortality in the Lung Health Study. Am J Respir Crit Care Med. 2002 Aug 1;166(3):333-9. doi: 10.1164/rccm.2110093.
PubMed 12153966Lopez-Sanchez M, Munoz-Esquerre M, Huertas D, Gonzalez-Costello J, Ribas J, Manresa F, Dorca J, Santos S. High Prevalence of Left Ventricle Diastolic Dysfunction in Severe COPD Associated with A Low Exercise Capacity: A Cross-Sectional Study. PLoS One. 2013 Jun 27;8(6):e68034. doi: 10.1371/journal.pone.0068034. Print 2013.
PubMed 23826360Barr RG, Bluemke DA, Ahmed FS, Carr JJ, Enright PL, Hoffman EA, Jiang R, Kawut SM, Kronmal RA, Lima JA, Shahar E, Smith LJ, Watson KE. Percent emphysema, airflow obstruction, and impaired left ventricular filling. N Engl J Med. 2010 Jan 21;362(3):217-27. doi: 10.1056/NEJMoa0808836.
PubMed 20089972Urban MH, Mayr AK, Schmidt I, Grasmuk-Siegl E, Burghuber OC, Funk GC. Effects of Dynamic Hyperinflation on Left Ventricular Diastolic Function in Healthy Subjects - A Randomized Controlled Crossover Trial. Front Med (Lausanne). 2021 May 4;8:659108. doi: 10.3389/fmed.2021.659108. eCollection 2021.
PubMed 34017848
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dynamic Hyperinflation on the Left-ventricular Diastolic Function in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03500822
- Acronym / sponsor ID
- Hyperstolic-COPD
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- dynamic hyperinflation, diastolic dysfunction, COPD, Chronic Obstructive Pulmonary Disease, Metronome-paced Tachypnea, Expiratory-stenosis Breathing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Otto Wagner HospitalUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Sep 2017 (actual)
- Study completion
- 29 Sep 2017 (actual)
- First posted
- 18 Apr 2018 (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.
The aim of this study is to identify whether actively induced dynamic hyperinflation can cause left-ventricular diastolic dysfunction in healthy male subjects in order to explore the mechanisms of developing cardiac dysfunctions in patients with COPD.
Detailed description
Cardiovascular diseases, especially left-ventricular diastolic dysfunction, are among the most frequent reasons for morbidity and mortality in patients with chronic obstructive pulmonary disease (COPD).
Dynamic hyperinflation is one of the expected pathophysiological mechanisms in the multifactorial genesis of this left-ventricular diastolic dysfunction in patients with COPD.
The novel concept of Expiratory Stenosis Breathing (ESB) is based on the method of Metronome-Paced Tachypnea (MPT) of Cooper et al. Therefore the investigators use a metronome to indicate a specific breathing frequency (BF) and the relation of inspiration : expiration (I : E) in order to let subjects hyperinflate.
Subjects get split into two groups each hyperinflating three times for 90sec by one of the two methods before doing a cross-over and switch groups to do the same in the other group. At the end of the 90sec there is a measurement of the Inspiratory Capacity (IC) and an echocardiography in order to objectify dynamic hyperinflation respectively the change in diastolic function.
During ESB participants hyperinflate with a BF - 30/min and a I : E - 1 : 3. In addition they have to breathe through an expiratory-effective stenosis (3, 2 and 1,5mm) on the mouthpiece of the pneumotachograph to simulate the collapsing airways in COPD-patients. In contrast, during MPT subjects hyperinflate with a BF - 40/min, I : E - 1 : 1; BF - 40/min, I : E - 1 : 2; BF - 30/min, I : E - 1 : 2.
During the whole trial investigators measure Intrinsic Positive Endexpiratory Pressure (PEEPi) in order to objectify the dynamic hyperinflation more significantly.
The primary goal of this study is to assess if actively induced dynamic hyperinflation can affect diastolic function of the left ventricle.
Furthermore a correlation between the extent of dynamic hyperinflation and diastolic dysfunction should be quantified.
In addition measurement of PEEPi should validate the method of Metronome-paced Tachypnea (MPT) because the investigators hypothesize that this method does not simulate the pathophysiological circumstances in patients with COPD sufficiently.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metronome-paced tachypnea | Experimental | Procedure: Metronome-paced tachypneaDynamic hyperinflation by the method of metronome-paced tachypnea. |
| Exspiratory-stenosis breathing | Experimental | Procedure: Expiratory-stenosis breathingDynamic hyperinflation by the method of expiratory-stenosis breathing. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI <27 kg/m2
- Lifelong nonsmoker (currently non-smoking and up to now less than 100 cigarettes)
Key exclusion criteria (4 listed)
- Obstructive pulmonary diseases (asthma, COPD)
- Cardiovascular diseases (cardiac insufficiency, coronary heart diseases, hypertonia)
- Other relevant pulmonary or cardiac diseases
- Baseline E/A-ratio <1
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 |
|---|---|---|
| Metronome-paced tachypneaAlso: MPTthree cycles: breathing frequency (BF) - 40/min, inspiration : expiration (I : E) - 1 : 1; BF - 40/min, I : E - 1 : 2; BF - 30/min, I : E - 1 : 2 | Procedure or surgery | Metronome-paced tachypnea |
| Expiratory-stenosis breathingAlso: ESBthree cycles: BF - /min, I : E - 1 : 3; stenosis: 3mm; 2mm; 1,5mm | Procedure or surgery | Exspiratory-stenosis breathing |
Primary outcome
E/A-ratio (absolute change between tidal breathing and smallest stenosis)
Time frame: At the end of each cycle - tidal breathing as well as hyperinflation-intervention (each cycle is at least 90 seconds).
E/A-ratio will be measured by transthoracic echocardiography (Vivid S9, general electric healthcare, Fairfield, USA) according to the valid standards of The European Association of Echocardiography. This parameter represents the left-ventricular diastolic function.
6 secondary outcomes
E/E'-ratio
Time frame: At the end of each cycle - tidal breathing as well as hyperinflation-intervention (each cycle is at least 90 seconds).
deceleration time of the E-wave transmitral (msec)
Time frame: At the end of each cycle - tidal breathing as well as hyperinflation-intervention (each cycle is at least 90 seconds).
Maximal diastolic transtricuspid flow (m/sec)
Time frame: At the end of each cycle - tidal breathing as well as hyperinflation-intervention (each cycle is at least 90 seconds).
Maximal late-systolic velocity of the lateral tricuspid valve in Tissue Doppler Imaging (cm/sec)
Time frame: At the end of each cycle - tidal breathing as well as hyperinflation-intervention (each cycle is at least 90 seconds).
Inspiratory Capacity
Time frame: At the end of each cycle - tidal breathing as well as hyperinflation-intervention (each cycle is at least 90 seconds).
Dynamic Intrinsic Positive Endexpiratory Pressure:
Time frame: During each entire cycle - tidal breathing as well as hyperinflation-intervention (each cycle is at least 90 seconds).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- Background: PubMed 23994176Cooper CB, Calligaro GL, Quinn MM, Eshaghian P, Coskun F, Abrazado M, Bateman ED, Raine RI. Determinants of dynamic hyperinflation during metronome-paced tachypnea in COPD and normal subjects. Respir Physiol Neurobiol. 2014 Jan 1;190:76-80. doi: 10.1016/j.resp.2013.08.002. Epub 2013 Aug 27.
- Background: PubMed 18972278Weigt SS, Abrazado M, Kleerup EC, Tashkin DP, Cooper CB. Time course and degree of hyperinflation with metronome-paced tachypnea in COPD patients. COPD. 2008 Oct;5(5):298-304. doi: 10.1080/15412550802363428.
- Background: PubMed 18579482Evangelista A, Flachskampf F, Lancellotti P, Badano L, Aguilar R, Monaghan M, Zamorano J, Nihoyannopoulos P; European Association of Echocardiography. European Association of Echocardiography recommendations for standardization of performance, digital storage and reporting of echocardiographic studies. Eur J Echocardiogr. 2008 Jul;9(4):438-48. doi: 10.1093/ejechocard/jen174.
- Background: PubMed 16055882Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
- Background: PubMed 24467647Akoumianaki E, Maggiore SM, Valenza F, Bellani G, Jubran A, Loring SH, Pelosi P, Talmor D, Grasso S, Chiumello D, Guerin C, Patroniti N, Ranieri VM, Gattinoni L, Nava S, Terragni PP, Pesenti A, Tobin M, Mancebo J, Brochard L; PLUG Working Group (Acute Respiratory Failure Section of the European Society of Intensive Care Medicine). The application of esophageal pressure measurement in patients with respiratory failure. Am J Respir Crit Care Med. 2014 Mar 1;189(5):520-31. doi: 10.1164/rccm.201312-2193CI.
- Background: PubMed 12153966Anthonisen NR, Connett JE, Enright PL, Manfreda J; Lung Health Study Research Group. Hospitalizations and mortality in the Lung Health Study. Am J Respir Crit Care Med. 2002 Aug 1;166(3):333-9. doi: 10.1164/rccm.2110093.
- Background: PubMed 23826360Lopez-Sanchez M, Munoz-Esquerre M, Huertas D, Gonzalez-Costello J, Ribas J, Manresa F, Dorca J, Santos S. High Prevalence of Left Ventricle Diastolic Dysfunction in Severe COPD Associated with A Low Exercise Capacity: A Cross-Sectional Study. PLoS One. 2013 Jun 27;8(6):e68034. doi: 10.1371/journal.pone.0068034. Print 2013.
- Background: PubMed 20089972Barr RG, Bluemke DA, Ahmed FS, Carr JJ, Enright PL, Hoffman EA, Jiang R, Kawut SM, Kronmal RA, Lima JA, Shahar E, Smith LJ, Watson KE. Percent emphysema, airflow obstruction, and impaired left ventricular filling. N Engl J Med. 2010 Jan 21;362(3):217-27. doi: 10.1056/NEJMoa0808836.
- Derived from this study: PubMed 34017848Urban MH, Mayr AK, Schmidt I, Grasmuk-Siegl E, Burghuber OC, Funk GC. Effects of Dynamic Hyperinflation on Left Ventricular Diastolic Function in Healthy Subjects - A Randomized Controlled Crossover Trial. Front Med (Lausanne). 2021 May 4;8:659108. doi: 10.3389/fmed.2021.659108. eCollection 2021.
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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. This study is not recruiting at the moment.
Georg C Funk, Assoc. Prof. principal investigator
Department of Respiratory and Critical Care Medicine and Ludwig-Boltzmann Institute for COPD and Respiratory Epidemiology, Otto Wagner Hospital, Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metronome-paced tachypnea and Expiratory-stenosis breathing in people with Pulmonary Disease, Chronic Obstructive, run by Otto Wagner Hospital at 1 site in Austria.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 18 Apr 2018. 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 Austria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
E/A-ratio (absolute change between tidal breathing and smallest stenosis) (time frame: At the end of each cycle - tidal breathing as well as hyperinflation-intervention (each cycle is at least 90 seconds).). 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 NCT03500822, which also lists 9 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 18 Apr 2018.