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

N/ANot Yet RecruitingNCT06265623

Universitätsklinikum Hamburg-Eppendorf148 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

148

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

University Medical Center Hamburg-Eppendorf, Institute of Clinical Pharmacology and Toxicology

Hamburg, Germany

Outcomes

Primary Outcomes

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

Time frame: 3 years

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Central Contacts

Rainer Böger, Prof. Dr.

CONTACT

+49-40-7410 boeger@uke.de

Juliane Hannemann, PD Dr.

CONTACT

+49-40-7410 ju.hannemann@uke.de

Data from ClinicalTrials.gov

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