Chronic Obstructive Pulmonary DiseasePACENCT04140097
Predictors of Acute Exacerbation in Patients With COPD - an Observational Study
An observational study of Chronic Obstructive Pulmonary Disease and COPD, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
Trial summary
Chronic obstructive pulmonary disease (COPD) is a lung disease characterized by respiratory problems and poor airflow with dyspnea and cough being the main symptoms. Acute exacerbations of COPD (AECOPD) are the most important events for patients with COPD that have a negative impact on patients´ quality of life… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, COPD, COPD Exacerbation
- What is being tested?
- Prospective monitoring of a large variety of parameters
- How many people
- 355 participants
- Where
- 1 siteGermany
- Study dates
- 26 Feb 2020to 30 Apr 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: Patients with Chronic Obstructive Pulmonary Disease that are referred to an inpatient pulmonary rehabilitation program at the reference center.
Who may be able to join
- confirmed diagnosis of Chronic Obstructive Pulmonary Disease according to Global Association for Obstructive Lung Disease stage II to IV
- the ability to follow the rehabilitation protocol
- provided written informed consent
Who cannot join
- current primary diagnosis of asthma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictors of Acute Exacerbation in Patients With COPD - an Observational Study (PACE Trial)
Chronic obstructive pulmonary disease (COPD) is a lung disease characterized by respiratory problems and poor airflow with dyspnea and cough being the main symptoms. Acute exacerbations of COPD (AECOPD) are the most important events for patients with COPD that have a negative impact on patients´ quality of life, accelerate disease progression, and can result in hospital admissions and death. It is of major clinical importance to determine predictors of an AECOPD and to identify patients who are at high risk for developing an acute exacerbation and/or to detect the beginning of or prevent an ongoing acute exacerbation as early as possible. Until now, research in the field of AECOPD has gathered and analyzed data only after manifestation of AECOPD until recovery and most of them used a retrospective study design. Therefore, the aim of this prospective trial is to collect clinical data in patients prior to the first visible clinical signs of an AECOPD to investigate potential early predictors of an AECOPD.
Read the detailed description
In total, 355 COPD patients will be included prospectively to this study during a 3-week inpatient pulmonary rehabilitation programme at the Schoen Klinik Berchtesgadener Land, Schoenau am Koenigssee, (Germany). All patients will be closely monitored from admission to the study. Measures of lung function, blood samples, breath sampling, exercise tests, physical activity monitoring, cardiac parameters, quality of life and a symptom diary will be recorded regularly. Prior knowledge from this programme suggest that about 15% of patients will develop an AECOPD during this observational phase. If a patient develops an AECOPD there will be a comprehensive diagnostic assessment to differentiate between cardiac, pulmonary or cardio-pulmonary reasons for the AECOPD and to identify the type of exacerbation. The clinical diagnosis and management of an AECOPD will be determined by a pulmonologist according to criteria of international guidelines within the first 24h after the onset of clinical symptoms suggestive of an exacerbation. Collected clinical data from the days prior to AECOPD will be analyzed comprehensively to identify parameters with high prediction power for AECOPD. Furthermore, patients will perform follow-up measures at 6, 12 and 24 months following the initial observational phase (PR phase).
A wide range of predictor screening methods will be applied to identify significant predictors including cross tabulation tables, correlations, generalized linear models, mixed models, generalized estimation equation models and various predictor screening methods based on variable selection algorithms.
Study objectives Primary endpoint: To prospectively identify potential early, respiratory and/ or cardiac clinical predictors, laboratory parameters, breath print analyses and/ or changes in lung function and physical activity prior to an AECOPD in COPD patients.
Secondary endpoint(s):
- To identify potential mechanisms explaining the nature and composition of an acute exacerbation in COPD patients
- To identify and differentiate patterns of acute COPD exacerbation versus cardiac failure in COPD patients
- To investigate the potential role of an electronic-nose to capture exhaled breath metabolomic profiles for the early detection of an acute exacerbation in COPD patients ("COPD pre exacerbation breath print")
- To identify parameters influencing mortality and other adverse events in the total study cohort at 6, 12 and 24 months follow up
- Being tested
- Prospective monitoring of a large variety of parameters
- Keywords
- Predictor, Development, Pulmonary Rehabilitation
- 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.
Prospective monitoring of a large variety of parametersOther
Patients will be recruited during an inpatient pulmonary rehabilitation program. This setting offers a unique opportunity to study the phenomenon of an acute exacerbation of the Chronic Obstructive Pulmonary Disease prior to the first visible clinical sign and further on to have a follow up of the underlying mechanisms. All COPD patients that are referred to the reference center for a rehabilitation program will be included after providing written informed consent. Prospectively, a wide range of measurements will be collected. If a patient develops an acute exacerbation there will be a comprehensive diagnostic assessment to differentiate between pulmonary, cardiac or cardio-pulmonary reasons for the exacerbation. The clinical diagnosis of an AECOPD will be made by a pulmonologist according to criteria of international guidelines within the first 24h of clinical symptoms suggestive of an exacerbation.
| Study group | Role | What they receive |
|---|---|---|
| COPD patients with acute exacerbation | Not described Receives: Other: Prospective monitoring of a large variety of parameters | |
| COPD patients without acute exacerbation | Not described Receives: Other: Prospective monitoring of a large variety of parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline laboratory parameters at day 21
following Parameters will be collected: c-reactive protein, cardiac Troponin I, hemoglobin A1c, Interleukin-1 beta, Interleukin-2, Interleukin-6, Interleukin 8, N-terminal probrain natriuretic peptide, Tumor necrosis factor alpha
Measured: baseline and day 21
Change from day 1 of an acute exacerbation in laboratory parameters at day 5
following Parameters will be collected: c-reactive protein, cardiac Troponin I, hemoglobin A1c, Interleukin-1 beta, Interleukin-2, Interleukin-6, Interleukin 8, N-terminal probrain natriuretic peptide, Tumor necrosis factor alpha
Measured: day 1 and 5 in case of an acute exacerbation
Change from baseline lung function at day 21
following Parameters will be collected: forced expiratory volume in 1 sec, forced vital capacity, total lung capacity, residual volume
Measured: baseline and day 21
Change from day 1 of an acute exacerbation in lung function at day 5
following Parameters will be collected: forced expiratory volume in 1 sec, forced vital capacity, total lung capacity, residual volume
Measured: day 1 and 5 in case of an acute exacerbation
Change from baseline Cardiac Doppler echocardiography at day 21
Left and right heart echocardiography will be performed
Measured: baseline and day 21
Change from day 1 of an acute exacerbation in Cardiac Doppler echocardiography at day 5
Left and right heart echocardiography will be performed
Measured: day 1 and 5 in case of an acute exacerbation
Change from baseline breath volatile organic compounds Analysis to day 4, 8, 11, 15 and 18
breath samples will be analyzed by ion-mobility spectrometry and gaschromatography/mass spectrometry
Measured: day 1, 4, 8, 11, 15, 18
Change in baseline exercise Performance at day 21
following tests will be performed: 6-Minute walk test, sit-to-stand-test, Peak quadriceps and Hand grip force,
Measured: day 1 and 21
Change from baseline Quality of life assessed by Short Form - 36 Questionnaire at days 21, day 180, day360, day 720
the scale of the physical and mental Health component summary score ranges from 0 to 100 Points with higher scores indicating better Quality of lif
Measured: baseline, day 21, day 180, day 360, day 720
Change from baseline functional status assessed by Modified Medical Research Counsil score at days 21, day 180, day360, day 720
the score ranges from category 0 to 4 with higher scores indicating higher impairment in function status
Measured: baseline, day 21, day 180, day 360, day 720
Change from baseline anxiety status assessed by Chronic Obstructive Pulmonary Disease Anxiety Questionnaire at days 21, day 180, day360, day 720
the total score ranges from 0 to 112 Points with higher scores indicating worse anxiety status
Measured: baseline, day 21, day 180, day 360, day 720
Change from baseline Depression status assessed by Patient Health Questionnaire 9 at days 21, day 180, day360, day 720
the total score ranges from 0 to 27 Points with higher scores indicating worse Depression symptoms
Measured: baseline, day 21, day 180, day 360, day 720
Change from baseline disease specific Quality of life assessed by Chronic Obstructive Pulmonary Disease Assessment Test at days 21, day 180, day360, day 720
total score ranges from 0 to 40 points with higher scores indicating worse quality of life
Measured: baseline, (day 1 and 5 in case of an acute exacerbation), day 21, day 180, day 360, day 720
Self-reported patient diary
The EXAcerbations of Chronic pulmonary disease Tool will be used
Measured: once daily from day 1 to day 21
physical activity monitoring
Using the Actigraph device following Parameters will be collected: steps per day and physical activity levels
Measured: continuous monitoring from day 1 to day 21
Change in Survival Status from baseline at 6, 12 and 24 months
Survival Status will be assessed by phone calls
Measured: baseline, at 6, 12 and 24 months
cough events
Number of nocturnal cough events recorded by NELA sound device (Carepath)
Measured: Recording from day 1 to day 21 at night only
Self-reported patient symptom diary
The COPD Exacerbation Recognition Tool (CERT) is used. The CERT asks about symptoms of increased cough, sputum production, shortness of breath, labored breathing, and reduced physical activity. The total score ranges from 0 (symptoms as usual) to 5 (severe deterioration compared to usual).
Measured: Once daily from day 1 to day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start26 Feb 2020
- Primary completion30 Apr 2024
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- 355 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schön Klinik Berchtesgadener Land
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline GmbH & Co. KG (Munich, Germany), Philipps University Marburg, Research Office (Biostatistics), Paracelsus Medical University (Salzburg, Austria), Fraunhofer ITEM, Biomedical Research in Endstage and Obstructive Lung Disease Hannover (BREATH), German Center for Lung Research (Hannover, Germany)
- Responsible party
- Principal investigator, Klaus Kenn, Schön Klinik Berchtesgadener Land
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04140097
- Sponsor's protocol ID
- PACE Trial
- Acronym
- PACE
- Status last verified
- Nov 2024
- First submitted
- 26 Sep 2019
- Last updated
- 8 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gloeckl R, Kenn K, Kroll D, Schneeberger T, Jarosch I, Wittenberg M, Hitzl W, Claussen J, Jones P, Vogelmeier CF, Koczulla R. Timely management of COPD exacerbations is associated with limited acute deterioration and early recovery: a prospective observational study. Respir Res. 2026 Jul 11;27(1):279. doi: 10.1186/s12931-026-03802-3.
PubMed 42432679Gloeckl R, Jones PW, Kroll D, Jarosch I, Schneeberger T, Claussen J, Schmidt P, Vogelmeier CF, Kenn K, Koczulla AR. Can Patient Education Lead the Way? Head-To-Head Comparison of EXACT and CERT for Early Recognition of Acute COPD Exacerbations. Respirology. 2026 Mar;31(3):256-264. doi: 10.1002/resp.70170. Epub 2025 Nov 30.
PubMed 41320645Kenn K, Gloeckl R, Leitl D, Schneeberger T, Jarosch I, Hitzl W, Alter P, Sczepanski B, Winterkamp S, Boensch M, Schade-Brittinger C, Skevaki C, Holz O, Jones PW, Vogelmeier CF, Koczulla AR. Protocol for an observational study to identify potential predictors of an acute exacerbation in patients with chronic obstructive pulmonary disease (the PACE Study). BMJ Open. 2021 Feb 8;11(2):e043014. doi: 10.1136/bmjopen-2020-043014.
PubMed 33558356
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Acute Exacerbation in Patients With COPD - an Observational Study (PACE Trial)
- ClinicalTrials.gov ID
- NCT04140097
- Acronym / sponsor ID
- PACE / PACE Trial
- Keywords
- Predictor, Development, Pulmonary Rehabilitation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 355 participants (actual)
- Lead sponsor
- Schön Klinik Berchtesgadener LandUniversity, hospital or other
- Collaborators
- GlaxoSmithKline GmbH & Co. KG (Munich, Germany), Philipps University Marburg, Research Office (Biostatistics), Paracelsus Medical University (Salzburg, Austria), Fraunhofer ITEM, Biomedical Research in Endstage and Obstructive Lung Disease Hannover (BREATH), German Center for Lung Research (Hannover, Germany)
- Study start
- 26 Feb 2020 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 25 Oct 2019 (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.
Chronic obstructive pulmonary disease (COPD) is a lung disease characterized by respiratory problems and poor airflow with dyspnea and cough being the main symptoms. Acute exacerbations of COPD (AECOPD) are the most important events for patients with COPD that have a negative impact on patients´ quality of life, accelerate disease progression, and can result in hospital admissions and death. It is of major clinical importance to determine predictors of an AECOPD and to identify patients who are at high risk for developing an acute exacerbation and/or to detect the beginning of or prevent an ongoing acute exacerbation as early as possible. Until now, research in the field of AECOPD has gathered and analyzed data only after manifestation of AECOPD until recovery and most of them used a retrospective study design. Therefore, the aim of this prospective trial is to collect clinical data in patients prior to the first visible clinical signs of an AECOPD to investigate potential early predictors of an AECOPD.
Detailed description
In total, 355 COPD patients will be included prospectively to this study during a 3-week inpatient pulmonary rehabilitation programme at the Schoen Klinik Berchtesgadener Land, Schoenau am Koenigssee, (Germany). All patients will be closely monitored from admission to the study. Measures of lung function, blood samples, breath sampling, exercise tests, physical activity monitoring, cardiac parameters, quality of life and a symptom diary will be recorded regularly. Prior knowledge from this programme suggest that about 15% of patients will develop an AECOPD during this observational phase. If a patient develops an AECOPD there will be a comprehensive diagnostic assessment to differentiate between cardiac, pulmonary or cardio-pulmonary reasons for the AECOPD and to identify the type of exacerbation. The clinical diagnosis and management of an AECOPD will be determined by a pulmonologist according to criteria of international guidelines within the first 24h after the onset of clinical symptoms suggestive of an exacerbation. Collected clinical data from the days prior to AECOPD will be analyzed comprehensively to identify parameters with high prediction power for AECOPD. Furthermore, patients will perform follow-up measures at 6, 12 and 24 months following the initial observational phase (PR phase).
A wide range of predictor screening methods will be applied to identify significant predictors including cross tabulation tables, correlations, generalized linear models, mixed models, generalized estimation equation models and various predictor screening methods based on variable selection algorithms.
Study objectives Primary endpoint: To prospectively identify potential early, respiratory and/ or cardiac clinical predictors, laboratory parameters, breath print analyses and/ or changes in lung function and physical activity prior to an AECOPD in COPD patients.
Secondary endpoint(s):
- To identify potential mechanisms explaining the nature and composition of an acute exacerbation in COPD patients
- To identify and differentiate patterns of acute COPD exacerbation versus cardiac failure in COPD patients
- To investigate the potential role of an electronic-nose to capture exhaled breath metabolomic profiles for the early detection of an acute exacerbation in COPD patients ("COPD pre exacerbation breath print")
- To identify parameters influencing mortality and other adverse events in the total study cohort at 6, 12 and 24 months follow up
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD patients with acute exacerbation | – | Other: Prospective monitoring of a large variety of parameters |
| COPD patients without acute exacerbation | – | Other: Prospective monitoring of a large variety of parameters |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Chronic Obstructive Pulmonary Disease that are referred to an inpatient pulmonary rehabilitation program at the reference center.
Key inclusion criteria (3 listed)
- confirmed diagnosis of Chronic Obstructive Pulmonary Disease according to Global Association for Obstructive Lung Disease stage II to IV
- the ability to follow the rehabilitation protocol
- provided written informed consent
Key exclusion criteria (1 listed)
- current primary diagnosis of asthma
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 |
|---|---|---|
| Prospective monitoring of a large variety of parametersPatients will be recruited during an inpatient pulmonary rehabilitation program. This setting offers a unique opportunity to study the phenomenon of an acute exacerbation of the Chronic Obstructive Pulmonary Disease prior to the first visible clinical sign and further on to have a follow up of the underlying mechanisms. All COPD patients that are referred to the reference center for a rehabilitation program will be included after providing written informed consent. Prospectively, a wide range of measurements will be collected. If a patient develops an acute exacerbation there will be a comprehensive diagnostic assessment to differentiate between pulmonary, cardiac or cardio-pulmonary reasons for the exacerbation. The clinical diagnosis of an AECOPD will be made by a pulmonologist according to criteria of international guidelines within the first 24h of clinical symptoms suggestive of an exacerbation. | Other | COPD patients with acute exacerbation, COPD patients without acute exacerbation |
Primary outcome
Change from baseline laboratory parameters at day 21
Time frame: baseline and day 21
following Parameters will be collected: c-reactive protein, cardiac Troponin I, hemoglobin A1c, Interleukin-1 beta, Interleukin-2, Interleukin-6, Interleukin 8, N-terminal probrain natriuretic peptide, Tumor necrosis factor alpha
Change from day 1 of an acute exacerbation in laboratory parameters at day 5
Time frame: day 1 and 5 in case of an acute exacerbation
following Parameters will be collected: c-reactive protein, cardiac Troponin I, hemoglobin A1c, Interleukin-1 beta, Interleukin-2, Interleukin-6, Interleukin 8, N-terminal probrain natriuretic peptide, Tumor necrosis factor alpha
Change from baseline lung function at day 21
Time frame: baseline and day 21
following Parameters will be collected: forced expiratory volume in 1 sec, forced vital capacity, total lung capacity, residual volume
Change from day 1 of an acute exacerbation in lung function at day 5
Time frame: day 1 and 5 in case of an acute exacerbation
following Parameters will be collected: forced expiratory volume in 1 sec, forced vital capacity, total lung capacity, residual volume
Change from baseline Cardiac Doppler echocardiography at day 21
Time frame: baseline and day 21
Left and right heart echocardiography will be performed
Change from day 1 of an acute exacerbation in Cardiac Doppler echocardiography at day 5
Time frame: day 1 and 5 in case of an acute exacerbation
Left and right heart echocardiography will be performed
Change from baseline breath volatile organic compounds Analysis to day 4, 8, 11, 15 and 18
Time frame: day 1, 4, 8, 11, 15, 18
breath samples will be analyzed by ion-mobility spectrometry and gaschromatography/mass spectrometry
Change in baseline exercise Performance at day 21
Time frame: day 1 and 21
following tests will be performed: 6-Minute walk test, sit-to-stand-test, Peak quadriceps and Hand grip force,
Change from baseline Quality of life assessed by Short Form - 36 Questionnaire at days 21, day 180, day360, day 720
Time frame: baseline, day 21, day 180, day 360, day 720
the scale of the physical and mental Health component summary score ranges from 0 to 100 Points with higher scores indicating better Quality of lif
Change from baseline functional status assessed by Modified Medical Research Counsil score at days 21, day 180, day360, day 720
Time frame: baseline, day 21, day 180, day 360, day 720
the score ranges from category 0 to 4 with higher scores indicating higher impairment in function status
Change from baseline anxiety status assessed by Chronic Obstructive Pulmonary Disease Anxiety Questionnaire at days 21, day 180, day360, day 720
Time frame: baseline, day 21, day 180, day 360, day 720
the total score ranges from 0 to 112 Points with higher scores indicating worse anxiety status
Change from baseline Depression status assessed by Patient Health Questionnaire 9 at days 21, day 180, day360, day 720
Time frame: baseline, day 21, day 180, day 360, day 720
the total score ranges from 0 to 27 Points with higher scores indicating worse Depression symptoms
Change from baseline disease specific Quality of life assessed by Chronic Obstructive Pulmonary Disease Assessment Test at days 21, day 180, day360, day 720
Time frame: baseline, (day 1 and 5 in case of an acute exacerbation), day 21, day 180, day 360, day 720
total score ranges from 0 to 40 points with higher scores indicating worse quality of life
Self-reported patient diary
Time frame: once daily from day 1 to day 21
The EXAcerbations of Chronic pulmonary disease Tool will be used
physical activity monitoring
Time frame: continuous monitoring from day 1 to day 21
Using the Actigraph device following Parameters will be collected: steps per day and physical activity levels
Change in Survival Status from baseline at 6, 12 and 24 months
Time frame: baseline, at 6, 12 and 24 months
Survival Status will be assessed by phone calls
cough events
Time frame: Recording from day 1 to day 21 at night only
Number of nocturnal cough events recorded by NELA sound device (Carepath)
Self-reported patient symptom diary
Time frame: Once daily from day 1 to day 21
The COPD Exacerbation Recognition Tool (CERT) is used. The CERT asks about symptoms of increased cough, sputum production, shortness of breath, labored breathing, and reduced physical activity. The total score ranges from 0 (symptoms as usual) to 5 (severe deterioration compared to usual).
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 8 Nov 2024.
- Derived from this study: PubMed 42432679Gloeckl R, Kenn K, Kroll D, Schneeberger T, Jarosch I, Wittenberg M, Hitzl W, Claussen J, Jones P, Vogelmeier CF, Koczulla R. Timely management of COPD exacerbations is associated with limited acute deterioration and early recovery: a prospective observational study. Respir Res. 2026 Jul 11;27(1):279. doi: 10.1186/s12931-026-03802-3.
- Derived from this study: PubMed 41320645Gloeckl R, Jones PW, Kroll D, Jarosch I, Schneeberger T, Claussen J, Schmidt P, Vogelmeier CF, Kenn K, Koczulla AR. Can Patient Education Lead the Way? Head-To-Head Comparison of EXACT and CERT for Early Recognition of Acute COPD Exacerbations. Respirology. 2026 Mar;31(3):256-264. doi: 10.1002/resp.70170. Epub 2025 Nov 30.
- Derived from this study: PubMed 33558356Kenn K, Gloeckl R, Leitl D, Schneeberger T, Jarosch I, Hitzl W, Alter P, Sczepanski B, Winterkamp S, Boensch M, Schade-Brittinger C, Skevaki C, Holz O, Jones PW, Vogelmeier CF, Koczulla AR. Protocol for an observational study to identify potential predictors of an acute exacerbation in patients with chronic obstructive pulmonary disease (the PACE Study). BMJ Open. 2021 Feb 8;11(2):e043014. doi: 10.1136/bmjopen-2020-043014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Chronic Obstructive Pulmonary Disease and COPD, run by Schön Klinik Berchtesgadener Land 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 3 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 8 Nov 2024. 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?
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?
Change from baseline laboratory parameters at day 21 (time frame: baseline and day 21). The study lists 18 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 NCT04140097, which also lists 3 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 8 Nov 2024.