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

Last updated: February 9, 2024
Sponsor: Universitätsklinikum Hamburg-Eppendorf
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Emphysema

Bronchiectasis

Chronic Obstructive Pulmonary Disease (Copd)

Treatment

No active intervention, but observational follow-up

Clinical Study ID

NCT06265623
UKE-IKPT 2024/01
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 familydoctor or pneumology specialist who are treated with long-acting bronchodilators on astable 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 bicycleergometry testing;
  4. Signed written informed consent form

Exclusion

Exclusion Criteria:

  1. Participation in another clinical study within the last 3 months before inclusion intothe present study;
  2. Any somatic or psychic disease that may hamper participation in the study orcompliance with the study protocol (at the investigator's discretion);
  3. Any somatic disease that puts the patient at increased risk when performing theexercise tests or impairs the patient's ability to properly perform the exercisetests, like advanced coronary artery disease, advanced chronic heart failure,uncontrolled hypertension, orthopaedic, or neurological diseases (non-exclusive listof examples);
  4. Any disease or health condition that reduces the patient's life expectancy to lessthan the expected time frame of this study, other than chronic obstructive lungdisease (at the investigator's discretion);
  5. Pregnancy or nursing.

Study Design

Total Participants: 148
Treatment Group(s): 1
Primary Treatment: No active intervention, but observational follow-up
Phase:
Study Start date:
March 01, 2024
Estimated Completion Date:
September 30, 2029

Study 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.

Connect with a study center

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

    Hamburg, 20246
    Germany

    Site Not Available

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