protocolSection identificationModule nctId: NCT06265623, orgStudyIdInfo id: UKE-IKPT 2024/01, briefTitle: Intermittent Hypoxemia, Lung Function Decline, Morbidity, and Mortality in COPD (PROSA Study)., acronym: PROSA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2028-09-30, completionDateStruct date: 2029-09-30, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Universitätsklinikum Hamburg-Eppendorf, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Chronic Obstructive Pulmonary Disease (COPD), designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 148, type: ESTIMATED, armsInterventionsModule interventions name: No active intervention, but observational follow-up, outcomesModule primaryOutcomes measure: Difference in FEV1(% of LLN) between baseline and end-of-follow-up, secondaryOutcomes measure: Difference in all-cause mortality during follow-up between groups, secondaryOutcomes measure: Difference in COPD-related mortality during follow-up between groups, secondaryOutcomes measure: Difference in frequency of hospital admissions for exacerbation of COPD during follow-up between groups, secondaryOutcomes measure: Difference in frequency of hospital admissions for causes other than exacerbation of COPD during follow-up between groups, secondaryOutcomes measure: Sensitivity of plasma biomarkers (spec. ADMA and SDMA) to predict the prevalence of exertional desaturation in COPD patients, secondaryOutcomes 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, secondaryOutcomes measure: Sensitivity and specificity of plasma biomarkers at baseline to prospectively predict the mortality rate in COPD patients, secondaryOutcomes 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, secondaryOutcomes 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, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Medical Center Hamburg-Eppendorf, Institute of Clinical Pharmacology and Toxicology, city: Hamburg, zip: 20246, country: Germany, contacts name: Rainer Böger, MD, role: CONTACT, email: boeger@uke.de, contacts name: Juliane Hannemann, PhD, role: CONTACT, email: j.hannemann@uke.de, geoPoint lat: 53.57532, lon: 10.01534, hasResults: False