Eosinophilic Cationic Protein as a Biomarker in Diagnosis of Acute Exacerbation of Chronic Obstructive Pulmonary Disease

The Role of Eosinophilic Cationic Protein as a Biomarker in Diagnosis of Acute Exacerbation of Chronic Obstructive Pulmonary Disease at Assiut University Hospital

Chronic obstructive pulmonary disease is a type of obstructive lung disease characterized by long-term breathing problems and poor airflow. It is changed to acute exacerbation of Chronic obstructive pulmonary disease when respiratory symptoms worsen, beyond normal day-to-day variations, severely enough that changes in medication are required.

Inflammation is a core feature of acute exacerbation of Chronic obstructive pulmonary disease since it gives insight into the pathological changes causing an exacerbation. Eosinophils may play a significant role in airway inflammation in some patients with Chronic obstructive pulmonary disease.

Previous studies have indicated that eosinophilic airway inflammation is also associated with the development of severe acute exacerbation of Chronic obstructive pulmonary disease. Eosinophilic Cationic Protein has various biological activities, including antibacterial, antiviral, antiparasitic and neurotoxic functions, and it contributes to the regulation of fibroblast activity. Eosinophilic Cationic Protein also induces airway mucus secretion and interacts with the coagulation and complement systems. Eosinophilic Cationic Protein has been developed as a marker for eosinophilic disease and quantified in biological fluids including serum, bronchoalveolar lavage and nasal secretions. It is found in diseases such as allergic asthma and allergic rhinitis but also occasionally in other diseases. Only activated eosinophil granulocytes release the granule content and therefore the determination of Eosinophilic Cationic Protein concentration is a considerably more specific indicator of eosinophil inflammation than eosinophil granulocyte count in peripheral blood as serum Eosinophilic Cationic Protein levels increase during acute exacerbation of Chronic obstructive pulmonary disease

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Diagnostic test: Eosinophilic Cationic Protein biomarker

• Study Type: Observational
• Enrollment (Anticipated): 64

Contacts and Locations

• Study Contact: Name: Alaa EL-Minshawy, MBBCh; Phone Number: 00201128892117; Email: alaa01194@med.au.edu.eg
• Study Contact Backup: Name: Randa Ahmed, MD; Phone Number: 00201003390690; Email: randaelzohne@yahoo.com

Study Locations

• Egypt
  • Assiut, Egypt
    • Recruiting
    • Assiut Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with confirmed diagnosis of Chronic obstructive pulmonary disease and acute exacerbation of Chronic obstructive pulmonary disease based on Gold guidelines, at the Chest Department and Respiratory Intensive Care Unit and chest outpatient clinic at Assiut University Hospital.

Description

Inclusion Criteria:

• clinical features of Chronic obstructive pulmonary disease
• spirometry compatible with the GOLD criteria (Forced expiratory volume 1/ Forced vital capacity <70%) post bronchodilator.

Exclusion Criteria:

• Patients with bronchial asthma
• Asthma -Chronic obstructive pulmonary disease overlap syndrome
• Atopic patients
• Pneumothorax
• Congestive heart failure
• Cancer of any kind
• A history of major surgery in the preceding 4 weeks.
• Patients undergoing mechanical ventilation or presenting with azotaemia (serum creatinine >1.5 mg/dl).

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
stable Chronic obstructive pulmonary disease; clinical features of Chronic obstructive pulmonary disease and associated spirometry compatible with the GOLD criteria (Forced expiratory volume 1/ Forced vital capacity <70%) post bronchodilator	Diagnostic test: Eosinophilic Cationic Protein biomarker; 3 ml blood for serum sample for estimation of Eosinophilic Cationic Protein biomarker level using ELISA
acute exacerbation of Chronic obstructive pulmonary disease; patients developed fever, increased dyspnea and sputum production plus the clinical features of Chronic obstructive pulmonary disease and associated spirometry compatible with the GOLD criteria (Forced expiratory volume 1/ Forced vital capacity <70%) post bronchodilator	Diagnostic test: Eosinophilic Cationic Protein biomarker; 3 ml blood for serum sample for estimation of Eosinophilic Cationic Protein biomarker level using ELISA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The mean difference in the level of Eosinophilic Cationic Protein biomarker in the two study groups	measurement by ELISA	3 months

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: July 2, 2019
• First Submitted That Met QC Criteria: July 2, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): April 23, 2021
• Last Update Submitted That Met QC Criteria: April 22, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Immunologic Factors; Eosinophil Cationic Protein
• Other Study ID Numbers: COPD-ECP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No