NCT06505902Completed
Pulmonary Diffusing Capacity During Incremental Exercise in COPD
Pulmonary Diffusing Capacity During Incremental Exercise in COPD: A Case-Control Study
Source: ClinicalTrials.gov · Last updated 24 Apr 2025
Brief summary (registry, in English)
Background: The combined measurement of pulmonary diffusing capacity for carbon monoxide (CO) and nitric oxide (NO) (DL,CO,NO) has recently been standardized and validated for clinical use. It involves a noticeably short breath-hold time (≤5 seconds), making it feasible to perform on patients with chronic obstructive pulmonary disease (COPD). These patients have lower diffusing capacity and are unable to increase it during exercise, which is thought to be caused by changes in pulmonary perfusion potentially leading to exertional dyspnea. The aim of the present study is to examine whether pulmonary diffusing capacity for incremental exercise differs between patients with COPD and matched healthy controls. Methods: Inclusion of 12 individuals with mild-to-severe COPD and 12 healthy age- and sex-matched controls. Design: Case-control study Intervention: DL,CO,NO and arterial blood gases will be measured during exercise at a bicycle ergometer at 0, 20, 40, 60 and 80% of the individual's maximal workload. Sample size: To detect a 15 mmol min-1 kPa-1 difference in DL,NO between groups at 60% of maximal workload, with a power of 90% and a significance level of 0.05, at least 12 subjects are required in each group. To account for potential dropouts, power will be permitted to decrease to 80%, corresponding to a total of 10 subjects in each group. Statistical design: Linear mixed effect model and pairwise testing of estimated marginal means. Perspective: This study will add to the understanding exertional dyspnoea in patients with COPD.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 24 (actual)
- First submitted
- 8 Jul 2024
- Start date
- 15 Jul 2024
- Primary completion date
- 1 Feb 2025
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Diseases
- COPD
- NCT number
- NCT06505902
What you commit to
- Study type: Interventional
- Participants enrolled: 24
- From 15 Jul 2024 to the primary completion date, 1 Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Symptoms of infection (bacterial/viral) within 2 weeks prior to the study
- Symptoms of infection (bacterial/viral) within 2 weeks prior to the study
Other illness
- Known ischaemic heart disease
- Known heart failure
- Cardiac arrythmias
- Dementia or other severe neurological disease
- Known vascular ischaemic disease
- Known ischaemic heart disease
- Known heart failure
- Cardiac arrythmias
- Dementia or other severe neurological disease
- Known vascular ischaemic disease
Other
- Pregnancy
- COPD
- Pregnancy
Who the study is looking for
- Men and women
- 40-80 years
- Mild to severe COPD (GOLD stage I to IIII)
- Men and women
- Age +/- 3 years of an included COPD patient
Age in the registry: 40 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Center for Aktiv Sundhed (CFAS), Rigshospitalet, Copenhagen, Denmark. Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.