NCT07185581

Brief Summary

This study aimed to evaluate small airway function during ECOPD and recovery periods using IOS. In this prospective single-center study, patients with ECOPD underwent evaluation of their pulmonary functions using IOS and spirometry during exacerbation and recovery (6-12 weeks after exacerbation). The patients were divided into two groups: mild exacerbations and (moderate and severe) exacerbations based on ROME criteria.A total of 41 patients were initially enrolled, with 38 completing the study. This study reveals that IOS can be easily used in ECOPD, and IOS parameters that reflect small airways (R5-R20, AX, and Fres) are correlated with FEV1% and the severity of dyspnea. Additionally, IOS parameters significantly improve during recovery, except for R20. Further research is necessary on its application in the functional assessment of patients with COPD exacerbations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

March 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 22, 2025

Completed
Last Updated

September 22, 2025

Status Verified

September 1, 2025

Enrollment Period

7 months

First QC Date

September 4, 2025

Last Update Submit

September 15, 2025

Conditions

Keywords

copdexacerbationiossmall airway

Outcome Measures

Primary Outcomes (1)

  • Physiological parameter of IOS in COPD exacerbation period

    We investigated descriptive parameters of impulse oscillometry during copd exacerbation period to use in clinical setting in the future. The parameters for assessing airway resistance, including resistance at 5 Hz (R5), which indicates total airway resistance; resistance at 20 Hz (R20), representing the resistance of large airways; and the difference between resistance at 5 Hz and 20 Hz ( R5-R20 ). The parameters that assess reactance are X5, which measures peripheral elastic resistance at 5 Hz; AX, the area under the reactance curve between 5 Hz and the resonant frequency, reflecting the elastic properties of the lung; and Fres, the oscillation frequency at which reactance is zero. In the exacerbation of copd period FEV1% was correlated with all IOS parameters except R20, and BORG was correlated with IOS parameters except R20 and X5. Furthermore, IOS parameters reflecting the small airways (R5-R20, X5, AX, Fres) also showed strong intercorrelations.

    from baseline

Secondary Outcomes (2)

  • Comparison of parameter of IOS in COPD exacerbation period to stable period (approximately 6 weeks later)

    6 weeks later from the baseline

  • Comparison and correlations of IOS and pulmonary function test parameters in recovery period of COPD patient

    6 weeks later from the baseline

Study Arms (2)

mild exacerbations

Patients were divided into two groups: mild exacerbations (group 1) and moderate and severe exacerbations (group 2) based on ROME criteria.

Diagnostic Test: Impulse Oscillometry

moderate and severe exacerbations

Patients were divided into two groups: mild exacerbations (group 1) and moderate and severe exacerbations (group 2) based on ROME criteria.

Diagnostic Test: Impulse Oscillometry

Interventions

Impulse OscillometryDIAGNOSTIC_TEST

Impulse Oscillometry (IOS) is a simple, non-invasive, effort-independent method that uses sound waves to detect airway changes quickly. It only requires the patient to breathe normally to assess lung function by measuring both resistance and reactance of the airways. 6,7 These features of IOS suggest it may be a useful test for assessing patient respiratory function during exacerbation periods when airway resistance, airflow limitation, and respiratory muscle weakness further impair breathing.

Also known as: ios
mild exacerbationsmoderate and severe exacerbations

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

41 patients who were consecutively admitted to the emergency department or pulmonology outpatient clinic of our hospital with a diagnosis of ECOPD, as defined by the GOLD 2023 Report 1 , were enrolled in the study.

You may qualify if:

  • patients who were consecutively admitted to the emergency department or pulmonology outpatient clinic of our hospital with a diagnosis of ECOPD, as defined by the GOLD 2023 Report

You may not qualify if:

  • Patients diagnosed with pneumonia, pulmonary embolism, heart failure, pleural effusion, or pneumothorax were excluded.
  • Patients who were unable to perform spirometry during exacerbation or had a forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) ratio of ≥ 0.70 were also excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medeniyet University

Istanbul, Turkey (Türkiye)

Location

Related Publications (32)

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    RESULT
  • Celli BR, Fabbri LM, Aaron SD, Agusti A, Brook R, Criner GJ, Franssen FME, Humbert M, Hurst JR, O'Donnell D, Pantoni L, Papi A, Rodriguez-Roisin R, Sethi S, Torres A, Vogelmeier CF, Wedzicha JA. An Updated Definition and Severity Classification of Chronic Obstructive Pulmonary Disease Exacerbations: The Rome Proposal. Am J Respir Crit Care Med. 2021 Dec 1;204(11):1251-1258. doi: 10.1164/rccm.202108-1819PP. No abstract available.

  • Vogelmeier CF, Criner GJ, Martinez FJ, Anzueto A, Barnes PJ, Bourbeau J, Celli BR, Chen R, Decramer M, Fabbri LM, Frith P, Halpin DM, Lopez Varela MV, Nishimura M, Roche N, Rodriguez-Roisin R, Sin DD, Singh D, Stockley R, Vestbo J, Wedzicha JA, Agusti A. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease 2017 Report. GOLD Executive Summary. Am J Respir Crit Care Med. 2017 Mar 1;195(5):557-582. doi: 10.1164/rccm.201701-0218PP.

  • 1.Agustí A, Celli BR, Criner GJ et al. Global Initiative for Chronic Obstructive Lung Disease 2023 Report: GOLD Executive Summary. Eur Respir J 2023; 61(4):2300239. 2.Wedzicha JA, Seemungal TA. COPD exacerbations: defining their cause and prevention. Lancet 2007; 370(9589): 786-796.

    RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • Esma Seda Akalın, MD

    Istanbul Medeniyet University

    PRINCIPAL INVESTIGATOR
  • Deniz Koçak, Research Assistant

    Istanbul Medeniyet University

    PRINCIPAL INVESTIGATOR
  • Elif Hazal Karadağ, Research Assistant

    Istanbul Medeniyet University

    PRINCIPAL INVESTIGATOR
  • Burcu Arpınar Yiğitbaş, Associate professor:

    Istanbul Medeniyet University

    PRINCIPAL INVESTIGATOR
  • Deniz Bilici, MD

    Istanbul Medeniyet University

    PRINCIPAL INVESTIGATOR
  • Handan Ankaralı, Professor

    Istanbul Medeniyet University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
6 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
md

Study Record Dates

First Submitted

September 4, 2025

First Posted

September 22, 2025

Study Start

March 1, 2024

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

September 22, 2025

Record last verified: 2025-09

Locations