Clinical Assessments of Pulmonary Diffusing CapacityDiffLungNCT04963504
Pulmonary Diffusing Capacity During Postural Postural Changes and Acute Exercise
A study testing Rest-to-exercise and Sitting-to-supine in people with Clinical Assessments of Pulmonary Diffusing Capacity, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The combined measurement of the pulmonary diffusing capacity to carbon monoxide (CO) and nitric oxide (NO) (DLCO/NO) has recently been standardised and validated for clinical use. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Clinical Assessments of Pulmonary Diffusing Capacity
- What is being tested?
- Rest-to-exercise and Sitting-to-supine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Jul 2021to 30 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Regular exercise (1-3 timer per week)
Who cannot join
- Any known medical condition that requires regular medication or any known lung condition
- Smoking
- Symptoms of disease within 2 weeks prior to the study
- Abnormal lung function test
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pulmonary Diffusing Capacity Changes to Posture and Acute Exercise in Healthy Volunteers: a Randomised Test-retest Relaibility Study
The combined measurement of the pulmonary diffusing capacity to carbon monoxide (CO) and nitric oxide (NO) (DLCO/NO) has recently been standardised and validated for clinical use. It involves a very short breath-hold time (≤5 seconds), and it may be repeated up to 12 times without affecting measurements, and it is thus ideal for assessing acute changes in pulmonary diffusing capacity and its components during various physiological manoeuvres. The aim of the present study is to compare the test-retest reliability of pulmonary diffusing capacity measurements during postural changes (sitting vs. supine) vs. rest-to-exercise. DLCO/NO will either be measured in the sitting position during rest vs. exercise or in the sitting and supine posture, and this will be repeated within 1-7 days in 20 healthy individuals that will be randomised to one of the two interventions. Statistically,the test-retest relaibility of sitting-to-supine vs. rest-to-exercise changes in DLCO/NO will be compared by parametric methods.
- Being tested
- Rest-to-exercise, Sitting-to-supine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rest-to-exerciseDiagnostic test
Pulmonary diffusing capacity is assessed at rest and during exercise (70% of VO2max on a bicycle ergometer)
Sitting-to-supineDiagnostic test
Pulmonary diffusing capacity is assessed in the sitting and supine position
| Study group | Role | What they receive |
|---|---|---|
| Rest-to-exercise | Experimental | Not described Receives: Diagnostic Test: Rest-to-exercise |
| Sitting-to-supine | Experimental | Not described Receives: Diagnostic Test: Sitting-to-supine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between intervention DLNO/DLCO-ratio repeatability coefficient
Test-retest reliability coefficient of rest-to-exercise and supine-to-prone DLNO/DLCO-ratio
Measured: 1 week
Between intervention DLCO repeatability coefficient
Test-retest repeatability coefficient of rest-to-exercise and supine-to-prone DLCO
Measured: 1 week
Between intervention DLNO repeatability coefficient
Test-retest repeatability coefficient of rest-to-exercise and supine-to-prone DLNO
Measured: 1 week
Secondary outcomes (2)
Between intervention DM repeatability coefficient
Test-retest repeatability coefficient of rest-to-exercise and supine-to-prone DM
Measured: 1 week
Between intervention Vc repeatability coefficient
Test-retest repeatability coefficient of rest-to-exercise and supine-to-prone Vc
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start12 Jul 2021
- Primary completion30 Sep 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Assessments of Pulmonary Diffusing CapacityStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised study
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronan Berg, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Ronan Berg, MD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04963504
- Sponsor's protocol ID
- KF_458_21
- Acronym
- DiffLung
- Status last verified
- Nov 2021
- First submitted
- 5 Jul 2021
- Last updated
- 10 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Diffusing Capacity Changes to Posture and Acute Exercise in Healthy Volunteers: a Randomised Test-retest Relaibility Study
- ClinicalTrials.gov ID
- NCT04963504
- Acronym / sponsor ID
- DiffLung / KF_458_21
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 15 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The combined measurement of the pulmonary diffusing capacity to carbon monoxide (CO) and nitric oxide (NO) (DLCO/NO) has recently been standardised and validated for clinical use. It involves a very short breath-hold time (≤5 seconds), and it may be repeated up to 12 times without affecting measurements, and it is thus ideal for assessing acute changes in pulmonary diffusing capacity and its components during various physiological manoeuvres. The aim of the present study is to compare the test-retest reliability of pulmonary diffusing capacity measurements during postural changes (sitting vs. supine) vs. rest-to-exercise. DLCO/NO will either be measured in the sitting position during rest vs. exercise or in the sitting and supine posture, and this will be repeated within 1-7 days in 20 healthy individuals that will be randomised to one of the two interventions. Statistically,the test-retest relaibility of sitting-to-supine vs. rest-to-exercise changes in DLCO/NO will be compared by parametric methods.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised study
| Arm | Type | Receives |
|---|---|---|
| Rest-to-exercise | Experimental | Diagnostic Test: Rest-to-exercise |
| Sitting-to-supine | Experimental | Diagnostic Test: Sitting-to-supine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Regular exercise (1-3 timer per week)
Key exclusion criteria (5 listed)
- Any known medical condition that requires regular medication or any known lung condition
- Smoking
- Symptoms of disease within 2 weeks prior to the study
- Abnormal lung function test
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rest-to-exercisePulmonary diffusing capacity is assessed at rest and during exercise (70% of VO2max on a bicycle ergometer) | Diagnostic test | Rest-to-exercise |
| Sitting-to-supinePulmonary diffusing capacity is assessed in the sitting and supine position | Diagnostic test | Sitting-to-supine |
Primary outcome
Between intervention DLNO/DLCO-ratio repeatability coefficient
Time frame: 1 week
Test-retest reliability coefficient of rest-to-exercise and supine-to-prone DLNO/DLCO-ratio
Between intervention DLCO repeatability coefficient
Time frame: 1 week
Test-retest repeatability coefficient of rest-to-exercise and supine-to-prone DLCO
Between intervention DLNO repeatability coefficient
Time frame: 1 week
Test-retest repeatability coefficient of rest-to-exercise and supine-to-prone DLNO
2 secondary outcomes
Between intervention DM repeatability coefficient
Time frame: 1 week
Between intervention Vc repeatability coefficient
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
- Individual participant dataSharing planned: No. Data will be shared upon reasonable request.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronan Berg, MD principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rest-to-exercise and Sitting-to-supine in people with Clinical Assessments of Pulmonary Diffusing Capacity, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Between intervention DLNO/DLCO-ratio repeatability coefficient (time frame: 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2021.