COPDCOPD TiCONNCT06456047
Detection of Early Airway Obstruction in Patients With COPD Using RCexp
An observational study of COPD, run by East Slovak Institute for Cardiovascular Diseases.
Trial summary
We hypothesize that Cexp during tidal and forced exhalation implemented to the routine spirometer may detect airway obstruction earlier than conventional spirometric indices such as FEV1 and FEV1/FVC. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COPD
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: All patients that are subjected to routine spirometry
Inclusion Criteria: all patients eligible for routine spirometry if indicated as per the standard of care -
Exclusion Criteria: known pulmonary disease, post thoracic surgery
-
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Detection of Early Airway Obstruction in Patients With Chronic Obstructive Pulmonary Disease Using Expiratory Time Constant
We hypothesize that Cexp during tidal and forced exhalation implemented to the routine spirometer may detect airway obstruction earlier than conventional spirometric indices such as FEV1 and FEV1/FVC.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is the most common chronic lung disease worldwide, leading to significant morbidity, mortality, and high treatment costs. In 2020, the global prevalence of COPD was estimated to be 10.6%, affecting around 480 million people. The diagnosis of COPD in suspected patients is typically confirmed through routine spirometry, a simple noninvasive test that assesses the degree of airway obstruction. However, research has revealed that extensive small airway disease exists in COPD before it can be detected using traditional spirometric measures, such as forced expiratory volume in the first second (FEV1) and the ratio of FEV1 to forced expiratory capacity (FEV1/FVC). Efforts are underway to find new parameters to improve early detection of airway obstruction in patients with COPD. The expiratory time constant (RCexp) is a promising variable studied in critical care medicine and may also prove useful in pulmonology. Data from ventilated COPD patients demonstrate that prolonged RCexp was present in all patients with COPD. The FEV1/FVC ratio is currently the gold standard for diagnosing COPD, but it only yields a single calculated value. In contrast, RCexp may offer more precision as it reflects exhalation dynamics at multiple time points during exhalation. If there is a prolongation of subsequent RCexp towards the end of exhalation, it could indicate the presence of obstruction. We hypothesize that RCexp during tidal and forced exhalation implemented to the routine spirometer may detect airway obstruction earlier than conventional spirometric indices such as FEV1 and FEV1/FVC.
- Conditions
- COPD
- Keywords
- chronic obstructive pulmonary disease, expiratory time constant
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| all patients undergoing routine spirometry | all patients undergoing routine spirometry and have GOLD or STAR negative criteria but positive RCexp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association of early airway obstruction and positivity of RCexp
research correlation of RCexp1, RCexp2, and RCexp3 with FEV1 and FEV1/FVC in patients with known COPD and its correlation with healthy controls
Measured: January 2025 - December 2028
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East Slovak Institute for Cardiovascular Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filip Depta MD, East Slovak Institute for Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456047
- Sponsor's protocol ID
- VUSCH
- Acronym
- COPD TiCON
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Depending on secondary data analyses
Publications
Depta F, Euliano NR, Zdravkovic M, Torok P, Gentile MA. Time constant to determine PEEP levels in mechanically ventilated COVID-19 ARDS: a feasibility study. BMC Anesthesiol. 2022 Dec 13;22(1):387. doi: 10.1186/s12871-022-01935-8.
PubMed 36513978
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Early Airway Obstruction in Patients With Chronic Obstructive Pulmonary Disease Using Expiratory Time Constant
- ClinicalTrials.gov ID
- NCT06456047
- Acronym / sponsor ID
- COPD TiCON / VUSCH
- Conditions
- COPD
- Keywords
- chronic obstructive pulmonary disease, expiratory time constant
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- East Slovak Institute for Cardiovascular DiseasesUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 13 Jun 2024 (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.
We hypothesize that Cexp during tidal and forced exhalation implemented to the routine spirometer may detect airway obstruction earlier than conventional spirometric indices such as FEV1 and FEV1/FVC.
Detailed description
Chronic obstructive pulmonary disease (COPD) is the most common chronic lung disease worldwide, leading to significant morbidity, mortality, and high treatment costs. In 2020, the global prevalence of COPD was estimated to be 10.6%, affecting around 480 million people. The diagnosis of COPD in suspected patients is typically confirmed through routine spirometry, a simple noninvasive test that assesses the degree of airway obstruction. However, research has revealed that extensive small airway disease exists in COPD before it can be detected using traditional spirometric measures, such as forced expiratory volume in the first second (FEV1) and the ratio of FEV1 to forced expiratory capacity (FEV1/FVC). Efforts are underway to find new parameters to improve early detection of airway obstruction in patients with COPD. The expiratory time constant (RCexp) is a promising variable studied in critical care medicine and may also prove useful in pulmonology. Data from ventilated COPD patients demonstrate that prolonged RCexp was present in all patients with COPD. The FEV1/FVC ratio is currently the gold standard for diagnosing COPD, but it only yields a single calculated value. In contrast, RCexp may offer more precision as it reflects exhalation dynamics at multiple time points during exhalation. If there is a prolongation of subsequent RCexp towards the end of exhalation, it could indicate the presence of obstruction. We hypothesize that RCexp during tidal and forced exhalation implemented to the routine spirometer may detect airway obstruction earlier than conventional spirometric indices such as FEV1 and FEV1/FVC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all patients undergoing routine spirometry | – | –all patients undergoing routine spirometry and have GOLD or STAR negative criteria but positive RCexp |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients that are subjected to routine spirometry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association of early airway obstruction and positivity of RCexp
Time frame: January 2025 - December 2028
research correlation of RCexp1, RCexp2, and RCexp3 with FEV1 and FEV1/FVC in patients with known COPD and its correlation with healthy controls
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Results publication: PubMed 36513978Depta F, Euliano NR, Zdravkovic M, Torok P, Gentile MA. Time constant to determine PEEP levels in mechanically ventilated COVID-19 ARDS: a feasibility study. BMC Anesthesiol. 2022 Dec 13;22(1):387. doi: 10.1186/s12871-022-01935-8.
- Individual participant dataSharing planned: Undecided. Depending on secondary data analyses
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by East Slovak Institute for Cardiovascular Diseases.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Filip Depta, MD PhD (+421948507269, fdepta@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association of early airway obstruction and positivity of RCexp (time frame: January 2025 - December 2028). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06456047, which also lists 1 linked publication.
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 13 Jun 2024.