NCT07693127

Brief Summary

The purpose of this study is to evaluate if standard, easily accessible blood tests can help doctors predict the severity and outcomes of sudden flare-ups in patients with Chronic Obstructive Pulmonary Disease (COPD). When a patient's COPD suddenly worsens, an event called an acute exacerbation, it can lead to serious health complications, breathing difficulties, and hospitalization. Currently, doctors need simple and cost-effective ways to figure out early on which patients are at the highest risk for severe complications. This observational study will focus on specific components of a routine Complete Blood Count (CBC) test. Researchers will look at the size, volume, and variation of red blood cells (such as Red Cell Distribution Width, or RDW) and platelets. Both red blood cells and platelets are known to be affected by the body's systemic inflammatory response during a severe COPD flare-up. Participants will include adults over 18 years old who are admitted to the hospital for an acute exacerbation of COPD. As part of the study, researchers will collect and analyze routine clinical data, including:

  • Medical history and physical examination findings (including dyspnea severity).
  • Standard laboratory blood tests (evaluating red blood cells, platelets, kidney and liver function, and inflammation markers).
  • Arterial blood gas levels.
  • Pulmonary function tests (breathing tests to measure lung capacity).
  • High-resolution computed tomography (HRCT) chest scans. By analyzing this information, the study aims to determine if red blood cell and platelet indices can accurately predict important clinical outcomes. These outcomes include the need for Intensive Care Unit (ICU) admission, the need for a mechanical ventilator (breathing machine), the total length of the hospital stay, and in-hospital mortality. Identifying reliable biomarkers could help healthcare providers make faster, more targeted treatment decisions for COPD patients.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
50

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

June 28, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 9, 2026

Completed
23 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 9, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

June 28, 2026

Last Update Submit

July 3, 2026

Conditions

Keywords

Red Blood Cell IndicesPlatelet IndicesRed Cell Distribution Width (RDW)Mean Platelet Volume (MPV)Platelet Distribution Width (PDW)BiomarkersPrognosisSystemic Inflammation

Outcome Measures

Primary Outcomes (1)

  • Dyspnea Severity Score

    Dyspnea severity will be quantified using the modified Medical Research Council (mMRC) dyspnea scale. This scale evaluates the degree of breathlessness on a grading system from 0 to 4, with higher grades indicating more severe symptoms.

    Baseline

Secondary Outcomes (1)

  • Length of Hospital Stay

    From the date of hospital admission until the date of hospital discharge, assessed up to 30 days.

Study Arms (1)

AECOPD Patients

Adult patients (over 18 years of age) admitted to the Chest Diseases and Tuberculosis department with an Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD). Participants will undergo routine clinical and laboratory assessments, including complete blood counts to evaluate red blood cell and platelet indices, arterial blood gases, pulmonary function tests (PFTs), and high-resolution computed tomography (HRCT) to predict disease severity and clinical outcomes.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of adult patients (over 18 years of age) diagnosed with Chronic Obstructive Pulmonary Disease (COPD) who are admitted to the Chest Diseases and Tuberculosis Department at Assiut University Hospital due to an acute exacerbation of their condition (AECOPD).

You may qualify if:

  • Patients above 18 years admitted to the department with AECOPD defined as an event characterized by increased dyspnea and/or cough and sputum that worsens in ≤14 days.

You may not qualify if:

  • Primary reason for admission other than AECOPD.
  • The patient has a diagnosis of connective tissue disorder, inflammatory bowel disease, or hematological system diseases (such as malignancy, thalassemia, hemolytic anemia).

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

June 28, 2026

First Posted

July 9, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

July 9, 2026

Record last verified: 2026-07