Clinical trial NCT06265623: Intermittent Hypoxemia, Lung Function Decline, Morbidity, and Mortality in COPD (PROSA Study).
Official title: Prospective Observational Study to Assess the Influence of Intermittent Hypoxaemia on Lung Function Decline, Morbidity, and Mortality in COPD Patients (PROSA Study)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: lung function, prognosis, exercise testing, spirometry
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study will be conducted a patients with chronic obstructive pulmonary disease of all sexes aged 18 - 80 years. They must be graded as stage 2 - 3 according to GOLD criteria (FEV1 between 30 and 79% of the age-adjusted predicted value) and belong to groups B or E according to symptom scores (mMRC or CAT questionnaires) and exacerbation history.

Brief 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.

Detailed 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.

Eligibility criteria: 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 outcomes:
measure: Difference in FEV1(% of LLN) between baseline and end-of-follow-up
timeFrame: 3 years
Secondary outcomes:
measure: Difference in all-cause mortality during follow-up between groups
timeFrame: 3 years
measure: Difference in COPD-related mortality during follow-up between groups
timeFrame: 3 years
measure: Difference in frequency of hospital admissions for exacerbation of COPD during follow-up between groups
timeFrame: 3 years
measure: Difference in frequency of hospital admissions for causes other than exacerbation of COPD during follow-up between groups
timeFrame: 3 years
measure: Sensitivity of plasma biomarkers (spec. ADMA and SDMA) to predict the prevalence of exertional desaturation in COPD patients
timeFrame: 3 years
measure: Sensitivity and specificity of plasma biomarkers (spec. ADMA and SDMA) measured at baseline to prospectively predict the slope of lung function decline in COPD patients
timeFrame: 3 years
measure: Sensitivity and specificity of plasma biomarkers at baseline to prospectively predict the mortality rate in COPD patients
timeFrame: 3 years
measure: Difference in incidence and extent of exercise hypoxemia between carriers and non-carriers of single nucleotide polymorphisms (SNPs) in genes of the L-arginine - dimethylarginine pathway
timeFrame: 3 years
measure: Difference in positive and negative predictive value of bicycle ergometry, 6-minute walk test, and 15-sec breath-hold test to discriminate between COPD patients with exertional desaturation versus those without exertional desaturation
timeFrame: 3 years
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf, Institute of Clinical Pharmacology and Toxicology
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Rainer Böger, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: