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Not yet recruitingNCT07734883Updated Jul 29, 2026

Prevalence and Clinical Outcome of Eosinophilic COPD

An observational study in Chronic Obstructive Pulmonary Disease (COPD), Eosinophilic COPD and Acute Exacerbation of Chronic Obstructive Pulmonary Disease, sponsored by Assiut University. Not yet recruiting. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-07-29.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
70
Ages
40 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.
02

Conditions studied

  • Chronic Obstructive Pulmonary Disease (COPD)
  • Eosinophilic COPD
  • Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Keywords

  • Eosinophilic COPD
  • COPD Exacerbation
  • Blood Eosinophils
  • Sputum Eosinophilia
03

In context

Pulmonary Disease, Chronic Obstructive

4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.

This study's planned enrollment of 70 is below the median of 180 across 1,066 observational studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
70 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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).

06

What researchers measure

Primary outcomes

  1. Prevalence of Eosinophilic COPD

    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.

    Time frame: Baseline

Secondary outcomes

  1. Duration of Hospital Stay

    Total number of days the patient remains hospitalized from the time of admission until discharge.

    Time frame: From admission up to discharge, assessed up to 30 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07734883
Lead sponsor
Assiut University
Responsible party
Hagar Awadallah Fahmy Ragheb (Resident at Chest Diseases Department, Assiut University) — Principal investigator
First posted
Jul 29, 2026
Start date
Aug 2026 (estimated)
Primary completion
Aug 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Jul 29, 2026
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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