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Prevalence and Clinical Outcome of Eosinophilic COPD

25 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

70

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

N/A

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
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).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Prevalence of Eosinophilic COPD
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Duration of Hospital Stay
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 agosto 2026

Completamento primario (Stimato)

1 agosto 2027

Completamento dello studio (Stimato)

1 settembre 2027

Date di iscrizione allo studio

Primo inviato

25 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

25 luglio 2026

Primo Inserito (Effettivo)

29 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

29 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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