NCT06265623Not yet recruiting
Intermittent Hypoxemia, Lung Function Decline, Morbidity, and Mortality in COPD (PROSA Study).
Prospective Observational Study to Assess the Influence of Intermittent Hypoxaemia on Lung Function Decline, Morbidity, and Mortality in COPD Patients (PROSA Study)
Source: ClinicalTrials.gov · Last updated 20 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 148 (estimated)
- First submitted
- 9 Feb 2024
- Start date
- 1 Mar 2024
- Primary completion date
- 30 Sept 2028
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Diseases
- COPD
- NCT number
- NCT06265623
What you commit to
- Study type: Observational
- Planned participants: 148
- From 1 Mar 2024 to the primary completion date, 30 Sept 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with COPD stages 2-3 (groups B and E) on stable long-acting bronchodilators. They will be followed for 3 years to see how falling oxygen levels during exercise affect the disease.
- Age
- 18 to 80 years
- Sex
- Men and women can join.
- Disease stage
- COPD stages 2-3, groups B and E according to GOLD.
- Earlier treatment
- Must have taken long-acting bronchodilators at a stable dose for at least four months before joining.
Main reasons for not taking part
- Took part in another clinical study in the last 3 months
- Any illness that makes it hard to take part or follow the study plan
- Illness that makes exercise tests risky or hard to do, such as advanced coronary artery disease or advanced chronic heart failure
- Another illness that shortens life expectancy to less than the study time frame
- Pregnant or nursing
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in another clinical study within the last 3 months before inclusion into the present study;
Other illness
- 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);
Other
- Pregnancy or nursing.
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Medical Center Hamburg-Eppendorf, Institute of Clinical Pharmacology and Toxicology | Hamburg | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.