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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04008017
• Other study ID #: COPD-ECP
• Status: Recruiting
• Start date: August 1, 2019
• Est. completion date: December 2021

Study information

• Verified date: April 2021
• Source: Assiut University
• Contact: Alaa EL-Minshawy, MBBCh
• Phone: 00201128892117
• Email: alaa01194[@]med.au.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: December 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Diagnostic Test:
• Eosinophilic Cationic Protein biomarker
3 ml blood for serum sample for estimation of Eosinophilic Cationic Protein biomarker level using ELISA

Locations

Country	Name	City	State
Egypt	Assiut Faculty of Medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean difference in the level of Eosinophilic Cationic Protein biomarker in the two study groups	measurement by ELISA	3 months