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Prevalence and Clinical Outcome of Eosinophilic COPD

2026年7月25日 更新者:Hagar Awadallah Fahmy Ragheb、Assiut University

Prevalence and Clinical Outcome of Eosinophilic COPD at Assiut University

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.

調査の概要

詳細な説明

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.

研究の種類

観察的

入学 (推定)

70

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

なし

サンプリング方法

非確率サンプル

調査対象母集団

Patients aged > 40 years with a confirmed diagnosis of COPD according to GOLD 2026 guidelines, presenting with an acute exacerbation at the Department of Chest Disease and Tuberculosis at Assiut University Hospitals.

説明

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
Eosinophilic COPD
Patients > 40 years of age with a confirmed diagnosis of COPD (according to GOLD 2026 guidelines) presenting with an acute exacerbation, who are identified as having a blood eosinophil count > 300 cells/µL.
Non-eosinophilic COPD
Patients > 40 years of age with a confirmed diagnosis of COPD (according to GOLD 2026 guidelines) presenting with an acute exacerbation, who do not meet the criteria for eosinophilia (blood eosinophil count ≤ 300 cells/µL).

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Prevalence of Eosinophilic COPD
時間枠:Baseline
The proportion of patients presenting with an acute exacerbation of COPD who are identified as having the eosinophilic phenotype, defined as a peripheral blood eosinophil count greater than 300 cells/µL.
Baseline

二次結果の測定

結果測定
メジャーの説明
時間枠
Duration of Hospital Stay
時間枠:From admission up to discharge, assessed up to 30 days
Total number of days the patient remains hospitalized from the time of admission until discharge.
From admission up to discharge, assessed up to 30 days

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年8月1日

一次修了 (推定)

2027年8月1日

研究の完了 (推定)

2027年9月1日

試験登録日

最初に提出

2026年7月25日

QC基準を満たした最初の提出物

2026年7月25日

最初の投稿 (実際)

2026年7月29日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月29日

QC基準を満たした最後の更新が送信されました

2026年7月25日

最終確認日

2026年7月1日

詳しくは

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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