NCT06456047

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
33mo left

Started Jan 2025

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
Jan 2025Dec 2028

First Submitted

Initial submission to the registry

June 6, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 13, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Expected
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

12 months

First QC Date

June 6, 2024

Last Update Submit

June 6, 2024

Conditions

Keywords

chronic obstructive pulmonary diseaseexpiratory time constant

Outcome Measures

Primary Outcomes (1)

  • 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

    January 2025 - December 2028

Study Arms (1)

all patients undergoing routine spirometry

all patients undergoing routine spirometry and have GOLD or STAR negative criteria but positive RCexp

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients that are subjected to routine spirometry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 36513978BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

venous blood

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Filip Depta, MD PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

June 6, 2024

First Posted

June 13, 2024

Study Start

January 1, 2025

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2028

Last Updated

June 13, 2024

Record last verified: 2024-06