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

NCT04008017 | Unknown

• 1 other identifier: COPD-ECP
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• The mean difference in the level of Eosinophilic Cationic Protein biomarker in the two study groups

  measurement by ELISA

  3 months

Study Arms (2)

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

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

Interventions

Eosinophilic Cationic Protein biomarker DIAGNOSTIC_TEST

3 ml blood for serum sample for estimation of Eosinophilic Cationic Protein biomarker level using ELISA

acute exacerbation of Chronic obstructive pulmonary disease; stable Chronic obstructive pulmonary disease

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut Faculty of Medicine

Asyut, Egypt

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Alaa EL-Minshawy, MBBCh

CONTACT

00201128892117; alaa01194@med.au.edu.eg

Randa Ahmed, MD

CONTACT

00201003390690; randaelzohne@yahoo.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 5, 2019
• Study Start: August 1, 2019
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 23, 2021

Record last verified: 2021-04

Locations

EG (1)