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Detection of Early Airway Obstruction in Patients with COPD Using RCexp

Detection of Early Airway Obstruction in Patients with Chronic Obstructive Pulmonary Disease Using Expiratory Time Constant

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06456047
Acronym
COPD TiCON
Enrollment
1000
Registered
2024-06-13
Start date
2025-01-01
Completion date
2028-12-31
Last updated
2024-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Keywords

chronic obstructive pulmonary disease, expiratory time constant

Brief 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.

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.

Interventions

None listed

Sponsors

East Slovak Institute for Cardiovascular Diseases
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

all patients eligible for routine spirometry if indicated as per the standard of care -

Exclusion criteria

known pulmonary disease, post thoracic surgery \-

Design outcomes

Primary

MeasureTime frameDescription
Association of early airway obstruction and positivity of RCexpJanuary 2025 - December 2028research correlation of RCexp1, RCexp2, and RCexp3 with FEV1 and FEV1/FVC in patients with known COPD and its correlation with healthy controls

Contacts

Primary ContactFilip Depta, MD PhD
fdepta@gmail.com+421948507269

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026