Not Yet RecruitingNot Applicable

Intermittent Hypoxemia, Lung Function Decline, Morbidity, and Mortality in COPD (PROSA Study).

Germany148 participantsStarted 2024-03-01

Plain-language 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. Patients will be followed for a total of 3 years.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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.

What they're measuring

Difference in FEV1(% of LLN) between baseline and end-of-follow-up

Timeframe: 3 years

Trial details

NCT IDNCT06265623

SponsorUniversitätsklinikum Hamburg-Eppendorf

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-09-30

Contact for this trial

Rainer Böger, Prof. Dr.

+49-40-7410 boeger@uke.de

View on ClinicalTrials.gov More Chronic Obstructive Pulmonary Disease (COPD) trials