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

Universitätsklinikum Hamburg-Eppendorf

Status: Not yet enrolling

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Other: No active intervention, but observational follow-up

Study type: Observational

Funder types: Other

Identifiers

NCT06265623

UKE-IKPT 2024/01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 148 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

148 participants in 2 patient groups

COPD patients with exertional desaturation

Description:

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.

Treatment:

Other: No active intervention, but observational follow-up

COPD patients without exertional desaturation

Description:

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.

Treatment:

Other: No active intervention, but observational follow-up