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 Article Swipe
Rainer H. Böger
,
Juliane Hannemann
·
YOU?
·
· 2024
· Open Access
·
· DOI: https://doi.org/10.1186/s12890-024-03074-x
YOU?
·
· 2024
· Open Access
·
· DOI: https://doi.org/10.1186/s12890-024-03074-x
Background Chronic obstructive lung disease (COPD) has diverse molecular pathomechanisms and clinical courses which, however, are not fully mirrored by current therapy. Intermittent hypoxemia is a driver of lung function decline and poor outcome, e.g., in patients with concomitant obstructive sleep apnea. Transient hypoxemia during physical exercise has been suggested to act in a similar manner. The PROSA study is designed to prospectively assess whether the clinical course of COPD patients with or without exertional desaturation differs, and to address potential pathophysiological mechanisms and biomarkers. Methods 148 COPD patients (GOLD stage 2–3, groups B or C) will undergo exercise testing with continuous pulse oximetry. They will be followed for 36 months by spirometry, echocardiography, endothelial function testing, and biomarker analyses. Exercise testing will be performed by comparing the 6-min walk test (6MWT), bicycle ergometry, and a 15-sec breath-hold test. Exertional desaturation will be defined as SpO 2 < 90% or delta-SpO 2 ≥ 4% during the 6MWT. The primary endpoint will be the rate of decline of FEV1(LLN) between COPD patients with and without exertional desaturation. Discussion The PROSA Study is an investigator-initiated prospective study that was designed to prove or dismiss the hypothesis that COPD patients with exertional desaturation have a significantly more rapid rate of decline of lung function as compared to non-desaturators. A 20% difference in the primary endpoint was considered clinically significant; it can be detected with a power of 90%. If the primary endpoint will be met, exercise testing with continuous pulse oximetry can be used as a ubiquitously available, easy screening tool to prospectively assess the risk of rapid lung function decline in COPD patients at an early disease stage. This will allow to introduce personalized, risk-adapted therapy to improve COPD outcome in the long run. PROSA is exclusively funded by public funds provided by the European Research Council through an ERC Advanced Grant. Patient recruitment is ongoing; the PROSA results are expected to be available in 2028. Trial registration The PROSA Study has been prospectively registered at clinicaltrials.gov (register no. NCT06265623, dated 09.02.2024).
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- article
- Language
- en
- Landing Page
- https://doi.org/10.1186/s12890-024-03074-x
- https://bmcpulmmed.biomedcentral.com/counter/pdf/10.1186/s12890-024-03074-x
- OA Status
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- Cited By
- 1
- References
- 42
- Related Works
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- OpenAlex ID
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- OpenAlex ID
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https://openalex.org/W4399186617Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.1186/s12890-024-03074-xDigital Object Identifier
- Title
-
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 designWork title
- Type
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articleOpenAlex work type
- Language
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enPrimary language
- Publication year
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2024Year of publication
- Publication date
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2024-05-30Full publication date if available
- Authors
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Rainer H. Böger, Juliane HannemannList of authors in order
- Landing page
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https://doi.org/10.1186/s12890-024-03074-xPublisher landing page
- PDF URL
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https://bmcpulmmed.biomedcentral.com/counter/pdf/10.1186/s12890-024-03074-xDirect link to full text PDF
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goldOpen access status per OpenAlex
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https://bmcpulmmed.biomedcentral.com/counter/pdf/10.1186/s12890-024-03074-xDirect OA link when available
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Medicine, COPD, Hypoxemia, Cardiology, Internal medicine, Spirometry, Clinical endpoint, Pulmonary function testing, Pulse oximetry, Intensive care medicine, Physical therapy, Randomized controlled trial, Anesthesia, AsthmaTop concepts (fields/topics) attached by OpenAlex
- Cited by
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1Total citation count in OpenAlex
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2025: 1Per-year citation counts (last 5 years)
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10Other works algorithmically related by OpenAlex
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| citation_normalized_percentile.is_in_top_1_percent | False |
| citation_normalized_percentile.is_in_top_10_percent | False |