Prevalence and Clinical Outcome of Eosinophilic COPD

Официальное название

Prevalence and Clinical Outcome of Eosinophilic COPD at Assiut University

Обзор

Chronic Obstructive Pulmonary Disease (COPD) is a lung condition characterized by chronic breathing symptoms and progressive airflow blockages. A specific type of COPD, known as eosinophilic COPD, involves higher levels of white blood cells called eosinophils and is known to influence disease outcomes and treatment responses. Currently, there is limited data regarding the prevalence and clinical outcomes of eosinophilic COPD in Upper Egypt, particularly among patients at Assiut University Hospitals. The main objective of this prospective observational study is to determine how common eosinophilic COPD is among patients experiencing an acute worsening of their COPD symptoms (an exacerbation) at Assiut University Hospitals. The study also aims to evaluate the clinical outcomes associated with this specific phenotype. Researchers will observe patients over the age of 40 with a confirmed COPD diagnosis who are admitted to the hospital for an acute exacerbation. As part of their standard hospital care, participants will undergo routine clinical assessments, including a review of their medical history, physical examinations, lung function tests (spirometry), and standard blood tests to measure their blood eosinophil count. The study will compare patients with eosinophilic COPD to those with non-eosinophilic COPD. Researchers will specifically evaluate differences in the severity of the exacerbation, the duration of the hospital stay, and the need for ventilator support. The findings aim to contribute to better, more personalized treatment strategies and improved clinical outcomes for COPD patients in the region.

Подробное описание

This study seeks to evaluate the clinical significance and prevalence of the eosinophilic phenotype in patients presenting with an acute exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD). While elevated blood eosinophil counts have emerged as a practical biomarker for eosinophilic airway inflammation, often guiding treatment decisions, there is limited data regarding its prevalence and impact on clinical outcomes in Upper Egypt.

Upon admission, enrolled patients will undergo a comprehensive clinical assessment as part of their standard care. The study procedures and data collection methods include the following:

* Clinical History and Examination: Researchers will collect demographic data, smoking status (pack-years), and a history of comorbidities, such as cardiovascular diseases, diabetes, and obstructive sleep apnea. The frequency of previous exacerbations over the past 12 months will be recorded, alongside current maintenance therapies (e.g., LAMA, LABA, ICS, triple therapy, and long-term oxygen therapy). A full physical examination will be conducted to evaluate vital signs, Body Mass Index (BMI), and room air oxygen saturation. * Laboratory Investigations: A complete blood count (CBC) will be performed from a venous blood sample at admission and before discharge to measure the absolute peripheral blood eosinophil count. Arterial blood gases (ABG) will be analyzed on room air. To exclude parasitic infestations that could skew eosinophil counts, a stool analysis will be conducted. * Sputum Cytology: A single induced sputum sample will be collected following nebulization with 3% hypertonic saline. The sample will be homogenized, centrifuged, and stained to perform differential cell counts via light microscopy, allowing researchers to evaluate the correlation between sputum and blood eosinophilia. * Pulmonary Function and Radiological Assessment: Standard spirometry will be utilized to measure FEV1, FVC, and the FEV1/FVC ratio, classifying the patient's baseline COPD severity according to GOLD criteria (Mild to Very Severe). Radiological assessments will include a chest X-ray, with a CT scan performed if clinically indicated. * Exacerbation Management and Classification: The severity of the acute exacerbation will be classified (mild, moderate, or severe) based on GOLD 2026 thresholds, which incorporate dyspnea visual analog scale (VAS) scores, respiratory rate, heart rate, resting SaO2, and C-reactive protein (CRP) levels. Patients will receive standard pharmacological management for AECOPD as soon as possible, which may include short-acting bronchodilators, a short course of systemic corticosteroids, and antibiotics if purulent sputum or prior infection history is present.

Первичные конечные точки

• Prevalence of Eosinophilic COPD [Срок оценки: Baseline]

Вторичные конечные точки (1)

• Duration of Hospital Stay [Срок оценки: From admission up to discharge, assessed up to 30 days]

Критерии участия

Критерии включения

• Patients aged > 40 years.
• Confirmed diagnosis of COPD according to GOLD 2026 guidelines.
• Presented with acute exacerbation of COPD (AECOPD) characterized by the onset or worsening of at least two symptoms (cough, phlegm, purulent sputum, wheezing, or dyspnea) persisting for a minimum of 48 hours, excluding other potential causes, such as left or right cardiac dysfunction, pulmonary embolism, pneumothorax, pleural effusion, arrhythmia and other related diseases.

Критерии исключения

• Patients with asthma or asthma-COPD overlap.
• Patients who need ICU admission.
• Patients receiving systemic corticosteroids within the previous 4 weeks.
• Hematological disorders affecting eosinophil count.
• Active pulmonary tuberculosis.
• Parasitic infections confirmed by stool analysis.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07734883 · Outcomes of Eosinophilic COPD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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