NCT07757126

Brief Summary

This cross-sectional study aims to compare lung ultrasound findings, functional capacity, and dyspnea among patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD), patients with stable COPD, and healthy controls. The study will include approximately 60 participants divided into three groups (acute exacerbation COPD, stable COPD, and healthy controls). Participants will undergo comprehensive assessments including lung ultrasound, pulmonary function tests, the Modified Borg Scale, the Modified Medical Research Council (mMRC) Dyspnea Scale, the 6-Minute Walk Test, the 1-Minute Sit-to-Stand Test, the COPD Assessment Test (CAT), the Charlson Comorbidity Index, and the BODE Index. The primary objective is to determine differences in lung ultrasound abnormalities, particularly B-lines, consolidations, and lung ultrasound scores, and to investigate their relationship with functional capacity and dyspnea severity. The findings are expected to clarify the clinical utility of lung ultrasound as a non-invasive bedside assessment tool for evaluating disease severity and supporting comprehensive management of patients with COPD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2026

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

May 18, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2026

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 2, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 11, 2026

Completed
Last Updated

August 11, 2026

Status Verified

August 1, 2026

Enrollment Period

2 months

First QC Date

August 2, 2026

Last Update Submit

August 5, 2026

Conditions

Keywords

Chronic Obstructive Pulmonary Disease (COPD)Acute ExacerbationLung UltrasoundFunctional CapacityDyspnea

Outcome Measures

Primary Outcomes (1)

  • Lung Ultrasound Score

    Total lung ultrasound score (0-36) obtained using a standardized 12-zone lung ultrasound protocol. The score reflects the degree of lung aeration loss based on the presence of A-lines, B-lines, confluent B-lines, and consolidations.

    Baseline (Cross-sectional assessment)

Secondary Outcomes (16)

  • Six-Minute Walk Distance (6MWD)

    Baseline

  • One-Minute Sit-to-Stand Test

    Baseline

  • Modified Borg Dyspnea Scale

    Baseline

  • Modified Medical Research Council (mMRC) Dyspnea Scale

    Baseline

  • COPD Assessment Test (CAT)

    Baseline

  • +11 more secondary outcomes

Study Arms (3)

Acute Exacerbation COPD

Patients diagnosed with chronic obstructive pulmonary disease (COPD) who are experiencing an acute exacerbation. Participants will undergo lung ultrasound, pulmonary function testing, functional capacity assessment (6-Minute Walk Test and 1-Minute Sit-to-Stand Test), dyspnea evaluation (Modified Borg Scale and mMRC Dyspnea Scale), COPD Assessment Test (CAT), Charlson Comorbidity Index, and BODE Index.

Stable COPD

Patients with clinically stable chronic obstructive pulmonary disease (COPD) without an acute exacerbation. Participants will undergo the same assessments as the acute exacerbation group, including lung ultrasound, pulmonary function testing, functional capacity tests, dyspnea evaluation, CAT, Charlson Comorbidity Index, and BODE Index.

Healthy Controls

Age-matched healthy individuals without chronic pulmonary disease or other significant cardiopulmonary, neurological, orthopedic, or psychiatric disorders. Participants will undergo lung ultrasound, pulmonary function testing, functional capacity assessment, and dyspnea evaluation using the same standardized procedures as the COPD groups.

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults aged 40-75 years will be recruited from Munzur University and Tunceli State Hospital. The study population will consist of three groups: patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD), patients with clinically stable COPD, and age-matched healthy controls. Eligible participants will be enrolled consecutively after providing written informed consent and will undergo standardized assessments, including lung ultrasound, pulmonary function testing, functional capacity tests, dyspnea evaluation, and psychological assessments.

You may qualify if:

  • Acute Exacerbation COPD Group
  • Adults aged 40-65 years.
  • Diagnosis of chronic obstructive pulmonary disease (COPD) according to GOLD criteria.
  • Currently experiencing an acute exacerbation of COPD.
  • Able and willing to provide written informed consent.
  • Stable COPD Group
  • Adults aged 40-75 years.
  • Diagnosis of chronic obstructive pulmonary disease (COPD) according to GOLD criteria.
  • Clinically stable without an acute exacerbation at the time of assessment.
  • Able and willing to provide written informed consent.
  • Healthy Control Group
  • Adults aged 40-65 years.
  • No history of chronic pulmonary disease.
  • Able and willing to provide written informed consent.

You may not qualify if:

  • Presence of cardiovascular, neurological, orthopedic, psychiatric, or other systemic diseases that may affect study assessments.
  • Cognitive impairment or psychological conditions preventing completion of study procedures.
  • History of thoracic or major surgery that could influence pulmonary function or lung ultrasound findings.
  • Pregnancy.
  • Inability to perform pulmonary function testing or functional exercise tests.
  • Refusal or inability to provide written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Munzur University Faculty of Health Sciences

Tunceli, Turkey (Türkiye)

Location

Related Publications (1)

  • Volpicelli G, Elbarbary M, Blaivas M, Lichtenstein DA, Mathis G, Kirkpatrick AW, Melniker L, Gargani L, Noble VE, Via G, Dean A, Tsung JW, Soldati G, Copetti R, Bouhemad B, Reissig A, Agricola E, Rouby JJ, Arbelot C, Liteplo A, Sargsyan A, Silva F, Hoppmann R, Breitkreutz R, Seibel A, Neri L, Storti E, Petrovic T; International Liaison Committee on Lung Ultrasound (ILC-LUS) for International Consensus Conference on Lung Ultrasound (ICC-LUS). International evidence-based recommendations for point-of-care lung ultrasound. Intensive Care Med. 2012 Apr;38(4):577-91. doi: 10.1007/s00134-012-2513-4. Epub 2012 Mar 6.

    PMID: 22392031BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveDyspnea

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

August 2, 2026

First Posted

August 11, 2026

Study Start

May 18, 2026

Primary Completion

July 20, 2026

Study Completion

July 30, 2026

Last Updated

August 11, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations