Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
— PROSAOfficial title:
Prospective Observational Study to Assess the Influence of Intermittent Hypoxaemia on Lung Function Decline, Morbidity, and Mortality in COPD Patients (PROSA Study)
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.
Status | Not yet recruiting |
Enrollment | 148 |
Est. completion date | September 30, 2029 |
Est. primary completion date | September 30, 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Germany | University Medical Center Hamburg-Eppendorf, Institute of Clinical Pharmacology and Toxicology | Hamburg |
Lead Sponsor | Collaborator |
---|---|
Universitätsklinikum Hamburg-Eppendorf |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 3 years | |
Secondary | 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. | 3 years | |
Secondary | 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. | 3 years | |
Secondary | 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. | 3 years | |
Secondary | 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. | 3 years | |
Secondary | 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. | 3 years | |
Secondary | 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 | Prospective survival analysis (Kaplan-Meier) of plasma biomarkers measured at the time of study inclusion and the difference in FEV1(% of lower limit of normal) between baseline and last measurement during follow-up. | 3 years | |
Secondary | Sensitivity and specificity of plasma biomarkers at baseline to prospectively predict the mortality rate in COPD patients | Prospective survival analysis (Kaplan-Meier) of plasma biomarkers measured at the time of study inclusion and total mortality during follow-up. | 3 years | |
Secondary | 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 | Comparison of the rates of prevalence of exertional desaturation between homozygous carriers of the major versus minor allele of SNPs in the NOS III, DDAH1, DDAH2, PRMT1-9, AGXT2, and ARG1-2 genes. | 3 years | |
Secondary | 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 | Comparison of sensitivity and specificity analyses (ROC analyses) of the outcome of named exercise tests to detect exertional desaturation in study participants. | 3 years |
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