NCT07734883

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
13mo left

Started Aug 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 29, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

July 29, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

July 25, 2026

Last Update Submit

July 25, 2026

Conditions

Keywords

Eosinophilic COPDCOPD ExacerbationBlood EosinophilsSputum Eosinophilia

Outcome Measures

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.

    Baseline

Secondary Outcomes (1)

  • Duration of Hospital Stay

    From admission up to discharge, assessed up to 30 days

Study Arms (2)

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).

Eligibility Criteria

Age40 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident at Chest Diseases Department

Study Record Dates

First Submitted

July 25, 2026

First Posted

July 29, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

July 29, 2026

Record last verified: 2026-07