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Completed

NCT Number: NCT07757126

Lung Ultrasound With Acute Exacerbation and Stable COPD

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Dyspnea Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Munzur University Faculty of Health Sciences

Tunceli, Turkey (Türkiye)

About this study

Chronic obstructive pulmonary disease (COPD) is a progressive respiratory disease characterized by persistent airflow limitation, chronic respiratory symptoms, and recurrent exacerbations that contribute to substantial morbidity, mortality, and healthcare utilization. Acute exacerbations accelerate disease progression, impair functional capacity, increase dyspnea severity, and worsen quality of life. Early identification of pulmonary abnormalities during exacerbation is therefore essential for optimizing clinical management and improving patient outcomes.

Lung ultrasound (LUS) has emerged as a non-invasive, radiation-free, bedside imaging modality that enables rapid assessment of pulmonary pathology. LUS can identify clinically relevant findings such as B-lines, consolidations, pleural abnormalities, and pleural effusions, making it a valuable complementary tool in the evaluation of respiratory diseases. Because it is portable, repeatable, and safe, LUS is increasingly incorporated into the assessment and monitoring of patients with chronic respiratory disorders, including COPD. Despite these advantages, evidence regarding the role of lung ultrasound in distinguishing acute exacerbation from stable COPD and its relationship with clinical outcomes remains limited.

The present study is designed as a cross-sectional comparative study involving three groups: patients with acute exacerbation of COPD, patients with stable COPD, and healthy individuals. Approximately 60 participants will be recruited and undergo standardized assessments. Lung ultrasound will be performed using a 12-zone protocol to evaluate B-line distribution, A-line dominance, lung ultrasound score, consolidations, pleural effusion, and other sonographic abnormalities. Functional status and symptom burden will be assessed using the 6-Minute Walk Test (6MWT), 1-Minute Sit-to-Stand Test (1STS), Modified Borg Dyspnea Scale, modified Medical Research Council (mMRC) Dyspnea Scale, COPD Assessment Test (CAT), Charlson Comorbidity Index, BODE Index, and spirometry.

The primary objective of this study is to compare lung ultrasound findings, functional capacity, and dyspnea among patients with acute exacerbation COPD, stable COPD, and healthy controls. Additionally, the study aims to determine whether lung ultrasound findings are associated with functional impairment and symptom severity. The results are expected to provide evidence supporting the clinical utility of lung ultrasound as a rapid and comprehensive assessment tool that complements conventional clinical evaluation in COPD and contributes to multidisciplinary management strategies.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Lung Ultrasound Score

    Time frame: Baseline (Cross-sectional assessment)

    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.

Secondary outcomes

  1. Six-Minute Walk Distance (6MWD)

    Time frame: Baseline

    Functional exercise capacity assessed using the Six-Minute Walk Test according to American Thoracic Society (ATS) guidelines. The outcome is the total distance walked in six minutes, measured in meters (m). Higher walking distances indicate better functional exercise capacity. Although there is no fixed maximum distance, the practical measurement range extends from 0 m upward.

  2. One-Minute Sit-to-Stand Test

    Time frame: Baseline

    Functional capacity assessed by the total number of sit-to-stand repetitions completed in one minute.

  3. Modified Borg Dyspnea Scale

    Time frame: Baseline

    Perceived dyspnea intensity at rest and immediately after exercise assessed using the Modified Borg Dyspnea Scale. The Modified Borg Dyspnea Scale ranges from 0 to 10, where 0 indicates no breathlessness and 10 indicates maximal breathlessness. Lower scores indicate less dyspnea (better outcome), whereas higher scores indicate greater dyspnea (worse outcome).

  4. Modified Medical Research Council (mMRC) Dyspnea Scale

    Time frame: Baseline

    Dyspnea severity during daily activities assessed using the Modified Medical Research Council Dyspnea Scale. The Modified Medical Research Council Dyspnea Scale ranges from 0 to 4, where 0 indicates breathlessness only with strenuous exercise and 4 indicates severe breathlessness that prevents leaving the house or occurs during dressing or undressing. Lower scores indicate less dyspnea (better outcome), whereas higher scores indicate greater dyspnea severity (worse outcome).

  5. COPD Assessment Test (CAT)

    Time frame: Baseline

    COPD symptom burden and health status assessed using the Chronic Obstructive Pulmonary Disease Assessment Test. The Chronic Obstructive Pulmonary Disease Assessment Test consists of 8 items and ranges from 0 to 40, where 0 indicates no impact of COPD on health status and 40 indicates maximum impact. Lower scores indicate better health status and lower symptom burden (better outcome), whereas higher scores indicate worse health status and greater symptom burden (worse outcome).

  6. BODE Index

    Time frame: Baseline

    Disease severity and mortality risk assessed using the Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Index. The BODE Index ranges from 0 to 10, where 0 indicates the lowest disease severity and mortality risk and 10 indicates the highest disease severity and mortality risk. Lower scores indicate better clinical status and prognosis (better outcome), whereas higher scores indicate worse clinical status and increased mortality risk (worse outcome).

  7. Charlson Comorbidity Index

    Time frame: Baseline

    Comorbidity burden assessed using the Charlson Comorbidity Index. The Charlson Comorbidity Index ranges from 0 upward, with higher scores indicating a greater burden of comorbidity and an increased risk of mortality. A score of 0 indicates no comorbid conditions. Lower scores indicate a lower comorbidity burden (better outcome), whereas higher scores indicate a greater comorbidity burden (worse outcome).

  8. Depression Anxiety Stress Scale-21 - Depression Subscale

    Time frame: Baseline

    Depressive symptoms assessed using the Depression Anxiety Stress Scale-21 Depression Subscale. The Depression Anxiety Stress Scale-21 Depression Subscale ranges from 0 to 42, with higher scores indicating greater depressive symptom severity. Lower scores indicate fewer depressive symptoms (better outcome), whereas higher scores indicate more severe depressive symptoms (worse outcome).

  9. Depression Anxiety Stress Scale-21 - Stress Subscale

    Time frame: Baseline

    Stress symptoms assessed using the Depression Anxiety Stress Scale-21 Stress Subscale. The Depression Anxiety Stress Scale-21 Stress Subscale ranges from 0 to 42, with higher scores indicating greater stress symptom severity. Lower scores indicate fewer stress symptoms (better outcome), whereas higher scores indicate more severe stress symptoms (worse outcome).

  10. Depression Anxiety Stress Scale-21 - Anxiety Subscale

    Time frame: Baseline

    Anxiety symptoms assessed using the Depression Anxiety Stress Scale-21 Anxiety Subscale. The Depression Anxiety Stress Scale-21 Anxiety Subscale ranges from 0 to 42, with higher scores indicating greater anxiety symptom severity. Lower scores indicate fewer anxiety symptoms (better outcome), whereas higher scores indicate more severe anxiety symptoms (worse outcome).

  11. Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)

    Time frame: Baseline

    Anxiety symptoms assessed using the Hospital Anxiety and Depression Scale-Anxiety Subscale. The Hospital Anxiety and Depression Scale-Anxiety Subscale ranges from 0 to 21, where higher scores indicate greater anxiety severity. Lower scores indicate less anxiety (better outcome), whereas higher scores indicate more severe anxiety symptoms (worse outcome).

  12. Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D)

    Time frame: Baseline

    Depressive symptoms assessed using the Hospital Anxiety and Depression Scale-Depression Subscale. The Hospital Anxiety and Depression Scale-Depression Subscale ranges from 0 to 21, where higher scores indicate greater depression severity. Lower scores indicate fewer depressive symptoms (better outcome), whereas higher scores indicate more severe depressive symptoms (worse outcome).

  13. Forced Expiratory Volume in One Second (FEV1)

    Time frame: Baseline

    Pulmonary function assessed by spirometry. Forced Expiratory Volume in One Second (FEV1) expressed as percent predicted (%) based on reference values. Higher values indicate better pulmonary function.

  14. Forced Vital Capacity (FVC)

    Time frame: Baseline

    Pulmonary function assessed by spirometry. Forced Vital Capacity (FVC) expressed as percent predicted (%) based on reference values. Higher values indicate better pulmonary function.

  15. Peak Expiratory Flow (PEF)

    Time frame: Baseline

    Pulmonary function assessed by spirometry. Peak Expiratory Flow (PEF) expressed as percent predicted (%) based on reference values. Higher values indicate better pulmonary function.

  16. Forced Expiratory Flow at 25-75% of Forced Vital Capacity (FEF25-75%)

    Time frame: Baseline

    Pulmonary function assessed by spirometry. Forced Expiratory Flow at 25-75% of Forced Vital Capacity (FEF25-75%) expressed as percent predicted (%) based on reference values. Higher values indicate better pulmonary function.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Comparison of Lung Ultrasound Findings, Functional Capacity, and Dyspnea Between Patients With Acute Exacerbation and Stable Chronic Obstructive Pulmonary Disease

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 11, 2026
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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