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

NCT ID: NCT06265623

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 148 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2029-09-30

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

COPD patients with exertional desaturation

Patients with chronic obstructive pulmonary disease stages 2-3, groups B or E according to the GOLD Guideline (2023), who experience a drop in arterial oxygen saturation (by pulse oximetry) to \<90% or a drop by 4% or greater of the basal value during a six-minute walk test.

No active intervention, but observational follow-up

Intervention Type: OTHER

Patients remain in usual care by their pulmonary medicine specialists and are being observed during annual follow-up investigations during up to 3 years

COPD patients without exertional desaturation

Patients with chronic obstructive pulmonary disease stages 2-3, groups B or E according to the GOLD Guideline (2023), who do not experience a drop in arterial oxygen saturation (by pulse oximetry) to \<90% or a drop by 4% or greater of the basal value during a six-minute walk test.

No active intervention, but observational follow-up

Intervention Type: OTHER

Patients remain in usual care by their pulmonary medicine specialists and are being observed during annual follow-up investigations during up to 3 years

Interventions

No active intervention, but observational follow-up

Patients remain in usual care by their pulmonary medicine specialists and are being observed during annual follow-up investigations during up to 3 years

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Prof. Rainer H. Böger

Prof. Dr. med. Dr. h.c.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rainer Böger, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Locations

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

Hamburg, , Germany

Countries

Germany

Central Contacts

Rainer Böger, Prof. Dr.

Role: CONTACT

boeger@uke.de

+49-40-7410 ext. 59759

Juliane Hannemann, PD Dr.

Role: CONTACT

ju.hannemann@uke.de

+49-40-7410 ext. 59701

Facility Contacts

Rainer Böger, MD

Role: primary

boeger@uke.de

Juliane Hannemann, PhD

Role: backup

j.hannemann@uke.de

References

Boger R, Hannemann J. Defining the role of exertional hypoxemia and pulmonary vasoconstriction on lung function decline, morbidity, and mortality in patients with chronic obstructive lung disease - the PROSA study: rationale and study design. BMC Pulm Med. 2024 May 30;24(1):262. doi: 10.1186/s12890-024-03074-x.

Reference Type: DERIVED

PMID: 38816826 (View on PubMed)

Other Identifiers

UKE-IKPT 2024/01

Identifier Type: -

Identifier Source: org_study_id