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

NCT ID: NCT04008017

Last Updated: 2021-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-01

Study Completion Date

2021-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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

Eosinophilic Cationic Protein biomarker

Intervention Type 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

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

Eosinophilic Cationic Protein biomarker

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Eosinophilic Cationic Protein biomarker

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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).
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohamed Abbas

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut Faculty of Medicine

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Alaa EL-Minshawy, MBBCh

Role: CONTACT

00201128892117

Randa Ahmed, MD

Role: CONTACT

00201003390690

Facility Contacts

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Ahmed Abbas, MD

Role: primary

00201003385183

Other Identifiers

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COPD-ECP

Identifier Type: -

Identifier Source: org_study_id

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