No active intervention, but observational follow-up
No active intervention, but observational follow-up: 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 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
1. 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;
2. Age at inclusion 18 - 80 years;
3. Physical ability and willingness to perform 6-minute walk testing and bicycle ergometry testing;
4. Signed written informed consent form
Exclusion Criteria:
1. Participation in another clinical study within the last 3 months before inclusion into the present study;
2. Any somatic or psychic disease that may hamper participation in the study or compliance with the study protocol (at the investigator's discretion);
3. 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);
4. 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);
5. Pregnancy or nursing.
Primary outcome measure(s)
Difference in FEV1(% of LLN) between baseline and end-of-follow-up — 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
Trial sites (1)
Facility
City
Region
Status
University Medical Center Hamburg-Eppendorf, Institute of Clinical Pharmacology and Toxicology
Hamburg
Germany
More Universitätsklinikum Hamburg-Eppendorf trials in Germany
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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