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

• Sponsor: Assiut University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04008017
• Collaborator: (none)
• Enrollment: 64
• Location: 1
• Anticipated Duration (Months): 28
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Diagnostic Test: Eosinophilic Cationic Protein biomarker

Study Design

• Study Type: Observational
• Anticipated Enrollment: 64 participants
• Observational Model: Other
• Time Perspective: Cross-Sectional
• 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
• Actual Study Start Date: Aug 1, 2019
• Anticipated Primary Completion Date: Sep 1, 2021
• Anticipated Study Completion Date: Dec 1, 2021

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. The mean difference in the level of Eosinophilic Cationic Protein biomarker in the two study groups [3 months]

   measurement by ELISA

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut Faculty of Medicine	Assiut		Egypt

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmed Mohamed Abbas, Principal investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT04008017
• Other Study ID Numbers: COPD-ECP
• First Posted: Jul 5, 2019
• Last Update Posted: Apr 23, 2021
• Last Verified: Apr 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Eosinophil Cationic Protein

Study Results

No Results Posted as of Apr 23, 2021