Chronic Obstructive Pulmonary Disease (COPD)PROSANCT06265623
Intermittent Hypoxemia, Lung Function Decline, Morbidity, and Mortality in COPD (PROSA Study).
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
This study aims to analyze if patients with chronic obstructive lung disease who experience a decline of blood oxygen saturation during physical exercise have a disease course different from that of COPD patients who do not experience a decline in blood oxygen saturation during exercise. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- No active intervention, but observational follow-up
- How many people
- 148 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2024to 30 Sep 2029
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will be conducted a patients with chronic obstructive pulmonary disease of all sexes aged 18 - 80 years. They must be graded as stage 2 - 3 according to GOLD criteria (FEV1 between 30 and 79% of the age-adjusted predicted value) and belong to groups B or E according to symptom scores (mMRC or CAT questionnaires) and exacerbation history.
Who may be able to join
- Patients of both sexes with a diagnosis of chronic obstructive lung disease (COPD) stages 2-3, groups B and E according to GOLD 38 as assessed by their primary family doctor or pneumology specialist who are treated with long-acting bronchodilators on a stable dose for at least four months prior to inclusion into the study;
- Age at inclusion 18 - 80 years;
- Physical ability and willingness to perform 6-minute walk testing and bicycle ergometry testing;
- Signed written informed consent form
Who cannot join
- Participation in another clinical study within the last 3 months before inclusion into the present study;
- Any somatic or psychic disease that may hamper participation in the study or compliance with the study protocol (at the investigator's discretion);
- Any somatic disease that puts the patient at increased risk when performing the exercise tests or impairs the patient's ability to properly perform the exercise tests, like advanced coronary artery disease, advanced chronic heart failure, uncontrolled hypertension, orthopaedic, or neurological diseases (non-exclusive list of examples);
- Any disease or health condition that reduces the patient's life expectancy to less than the expected time frame of this study, other than chronic obstructive lung disease (at the investigator's discretion);
- Pregnancy or nursing.
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
University Medical Center Hamburg-Eppendorf, Institute of Clinical Pharmacology and Toxicology
Hamburg, 20246
Rainer Böger, MD, boeger@uke.de
Juliane Hannemann, PhD, j.hannemann@uke.de
About this study
Official title: Prospective Observational Study to Assess the Influence of Intermittent Hypoxaemia on Lung Function Decline, Morbidity, and Mortality in COPD Patients (PROSA Study)
This study aims to analyze if patients with chronic obstructive lung disease who experience a decline of blood oxygen saturation during physical exercise have a disease course different from that of COPD patients who do not experience a decline in blood oxygen saturation during exercise. Patients will be followed for a total of 3 years.
Read the detailed description
The major aim of the study is to test whether intermittent hypoxaemia is a major driver of the progression of chronic obstructive lung disease (COPD). The second aim is to analyse whether dysregulation of the L-arginine / dimethylarginine pathway is a mechanistic link between intermittent hypoxemia and lung function decline, and whether plasma biomarkers are suitable to identify COPD patients at high risk of rapid lung function decline and mortality.
- Being tested
- No active intervention, but observational follow-up
- Keywords
- lung function, prognosis, exercise testing, spirometry
- 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.
No active intervention, but observational follow-upOther
Patients remain in usual care by their pulmonary medicine specialists and are being observed during annual follow-up investigations during up to 3 years
| Study group | Role | What they receive |
|---|---|---|
| COPD patients with exertional desaturation | Patients with chronic obstructive pulmonary disease stages 2-3, groups B or E according to the GOLD Guideline (2023), who experience a drop in arterial oxygen saturation (by pulse oximetry) to <90% or a drop by 4% or greater of the basal value during a six-minute walk test. Receives: Other: No active intervention, but observational follow-up | |
| COPD patients without exertional desaturation | Patients with chronic obstructive pulmonary disease stages 2-3, groups B or E according to the GOLD Guideline (2023), who do not experience a drop in arterial oxygen saturation (by pulse oximetry) to <90% or a drop by 4% or greater of the basal value during a six-minute walk test. Receives: Other: No active intervention, but observational follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in FEV1(% of LLN) between baseline and end-of-follow-up
The difference in measured FEV1 assessed by spirometry and expressed as percent of the lower limit of the normal distribution based upon the Global Lung Function 2022 Equations, by comparing results of the baseline measurement with those of the last investigation during up to three years of follow-up
Measured: 3 years
Secondary outcomes (9)
Difference in all-cause mortality during follow-up between groups
Number of patients who died from any cause during follow-up in either of the two groups.
Measured: 3 years
Difference in COPD-related mortality during follow-up between groups
Number of patients who died from COPD and its complications during follow-up in either of the two groups.
Measured: 3 years
Difference in frequency of hospital admissions for exacerbation of COPD during follow-up between groups
Number of patients who were admitted to hospital because of exacerbated COPD during follow-up in either of the two groups.
Measured: 3 years
Difference in frequency of hospital admissions for causes other than exacerbation of COPD during follow-up between groups
Number of patients who were admitted to hospital for any other reason than exacerbated COPD during follow-up in either of the two groups.
Measured: 3 years
Sensitivity of plasma biomarkers (spec. ADMA and SDMA) to predict the prevalence of exertional desaturation in COPD patients
Sensitivity analysis (ROC analysis) of biomarkers and presence of exertional desaturation (as defined in the protocol) or not in study participants.
Measured: 3 years
Sensitivity and specificity of plasma biomarkers (spec. ADMA and SDMA) measured at baseline to prospectively predict the slope of lung function decline in COPD patients
Prospective survival analysis (Kaplan-Meier) of plasma biomarkers measured at the time of study inclusion and the difference in FEV1(% of lower limit of normal) between baseline and last measurement during follow-up.
Measured: 3 years
Sensitivity and specificity of plasma biomarkers at baseline to prospectively predict the mortality rate in COPD patients
Prospective survival analysis (Kaplan-Meier) of plasma biomarkers measured at the time of study inclusion and total mortality during follow-up.
Measured: 3 years
Difference in incidence and extent of exercise hypoxemia between carriers and non-carriers of single nucleotide polymorphisms (SNPs) in genes of the L-arginine - dimethylarginine pathway
Comparison of the rates of prevalence of exertional desaturation between homozygous carriers of the major versus minor allele of SNPs in the NOS III, DDAH1, DDAH2, PRMT1-9, AGXT2, and ARG1-2 genes.
Measured: 3 years
Difference in positive and negative predictive value of bicycle ergometry, 6-minute walk test, and 15-sec breath-hold test to discriminate between COPD patients with exertional desaturation versus those without exertional desaturation
Comparison of sensitivity and specificity analyses (ROC analyses) of the outcome of named exercise tests to detect exertional desaturation in study participants.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- 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
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Rainer H. Böger, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Rainer Böger, Prof. Dr., Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265623
- Sponsor's protocol ID
- UKE-IKPT 2024/01
- Acronym
- PROSA
- Status last verified
- Feb 2024
- First submitted
- 9 Feb 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon reasonable individual request, IPD can be made available for further analyses by other researchers.
Publications
Boger R, Hannemann J. Defining the role of exertional hypoxemia and pulmonary vasoconstriction on lung function decline, morbidity, and mortality in patients with chronic obstructive lung disease - the PROSA study: rationale and study design. BMC Pulm Med. 2024 May 30;24(1):262. doi: 10.1186/s12890-024-03074-x.
PubMed 38816826
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study to Assess the Influence of Intermittent Hypoxaemia on Lung Function Decline, Morbidity, and Mortality in COPD Patients (PROSA Study)
- ClinicalTrials.gov ID
- NCT06265623
- Acronym / sponsor ID
- PROSA / UKE-IKPT 2024/01
- Keywords
- lung function, prognosis, exercise testing, spirometry
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 20 Feb 2024 (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.
This study aims to analyze if patients with chronic obstructive lung disease who experience a decline of blood oxygen saturation during physical exercise have a disease course different from that of COPD patients who do not experience a decline in blood oxygen saturation during exercise. Patients will be followed for a total of 3 years.
Detailed description
The major aim of the study is to test whether intermittent hypoxaemia is a major driver of the progression of chronic obstructive lung disease (COPD). The second aim is to analyse whether dysregulation of the L-arginine / dimethylarginine pathway is a mechanistic link between intermittent hypoxemia and lung function decline, and whether plasma biomarkers are suitable to identify COPD patients at high risk of rapid lung function decline and mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD patients with exertional desaturation | – | Other: No active intervention, but observational follow-upPatients with chronic obstructive pulmonary disease stages 2-3, groups B or E according to the GOLD Guideline (2023), who experience a drop in arterial oxygen saturation (by pulse oximetry) to <90% or a drop by 4% or greater of the basal value during a six-minute walk test. |
| COPD patients without exertional desaturation | – | Other: No active intervention, but observational follow-upPatients with chronic obstructive pulmonary disease stages 2-3, groups B or E according to the GOLD Guideline (2023), who do not experience a drop in arterial oxygen saturation (by pulse oximetry) to <90% or a drop by 4% or greater of the basal value during a six-minute walk test. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will be conducted a patients with chronic obstructive pulmonary disease of all sexes aged 18 - 80 years. They must be graded as stage 2 - 3 according to GOLD criteria (FEV1 between 30 and 79% of the age-adjusted predicted value) and belong to groups B or E according to symptom scores (mMRC or CAT questionnaires) and exacerbation history.
Key inclusion criteria (4 listed)
- Patients of both sexes with a diagnosis of chronic obstructive lung disease (COPD) stages 2-3, groups B and E according to GOLD 38 as assessed by their primary family doctor or pneumology specialist who are treated with long-acting bronchodilators on a stable dose for at least four months prior to inclusion into the study;
- Age at inclusion 18 - 80 years;
- Physical ability and willingness to perform 6-minute walk testing and bicycle ergometry testing;
- Signed written informed consent form
Key exclusion criteria (5 listed)
- Participation in another clinical study within the last 3 months before inclusion into the present study;
- Any somatic or psychic disease that may hamper participation in the study or compliance with the study protocol (at the investigator's discretion);
- Any somatic disease that puts the patient at increased risk when performing the exercise tests or impairs the patient's ability to properly perform the exercise tests, like advanced coronary artery disease, advanced chronic heart failure, uncontrolled hypertension, orthopaedic, or neurological diseases (non-exclusive list of examples);
- Any disease or health condition that reduces the patient's life expectancy to less than the expected time frame of this study, other than chronic obstructive lung disease (at the investigator's discretion);
- Pregnancy or nursing.
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 |
|---|---|---|
| No active intervention, but observational follow-upPatients remain in usual care by their pulmonary medicine specialists and are being observed during annual follow-up investigations during up to 3 years | Other | COPD patients with exertional desaturation, COPD patients without exertional desaturation |
Primary outcome
Difference in FEV1(% of LLN) between baseline and end-of-follow-up
Time frame: 3 years
The difference in measured FEV1 assessed by spirometry and expressed as percent of the lower limit of the normal distribution based upon the Global Lung Function 2022 Equations, by comparing results of the baseline measurement with those of the last investigation during up to three years of follow-up
9 secondary outcomes
Difference in all-cause mortality during follow-up between groups
Time frame: 3 years
Difference in COPD-related mortality during follow-up between groups
Time frame: 3 years
Difference in frequency of hospital admissions for exacerbation of COPD during follow-up between groups
Time frame: 3 years
Difference in frequency of hospital admissions for causes other than exacerbation of COPD during follow-up between groups
Time frame: 3 years
Sensitivity of plasma biomarkers (spec. ADMA and SDMA) to predict the prevalence of exertional desaturation in COPD patients
Time frame: 3 years
Sensitivity and specificity of plasma biomarkers (spec. ADMA and SDMA) measured at baseline to prospectively predict the slope of lung function decline in COPD patients
Time frame: 3 years
Sensitivity and specificity of plasma biomarkers at baseline to prospectively predict the mortality rate in COPD patients
Time frame: 3 years
Difference in incidence and extent of exercise hypoxemia between carriers and non-carriers of single nucleotide polymorphisms (SNPs) in genes of the L-arginine - dimethylarginine pathway
Time frame: 3 years
Difference in positive and negative predictive value of bicycle ergometry, 6-minute walk test, and 15-sec breath-hold test to discriminate between COPD patients with exertional desaturation versus those without exertional desaturation
Time frame: 3 years
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 20 Feb 2024.
- Derived from this study: PubMed 38816826Boger R, Hannemann J. Defining the role of exertional hypoxemia and pulmonary vasoconstriction on lung function decline, morbidity, and mortality in patients with chronic obstructive lung disease - the PROSA study: rationale and study design. BMC Pulm Med. 2024 May 30;24(1):262. doi: 10.1186/s12890-024-03074-x.
- Individual participant dataSharing planned: Yes. Upon reasonable individual request, IPD can be made available for further analyses by other researchers.
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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.
Rainer Böger, Prof. Dr. principal investigator
Universitätsklinikum Hamburg-Eppendorf
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 (COPD), run by Universitätsklinikum Hamburg-Eppendorf 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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 20 Feb 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?
Contact Rainer Böger, Prof. Dr. (+49-40-7410 ext. 59759, boeger@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in FEV1(% of LLN) between baseline and end-of-follow-up (time frame: 3 years). 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 NCT06265623, which also lists 1 linked publication.
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 20 Feb 2024.