Chronic Obstructive Pulmonary DiseaseNCT04008017
Eosinophilic Cationic Protein as a Biomarker in Diagnosis of Acute Exacerbation of Chronic Obstructive Pulmonary Disease
An observational study of Chronic Obstructive Pulmonary Disease, run by Assiut University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Eosinophilic Cationic Protein biomarker
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2019to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- clinical features of Chronic obstructive pulmonary disease
- spirometry compatible with the GOLD criteria (Forced expiratory volume 1/ Forced vital capacity <70%) post bronchodilator.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut Faculty of Medicine
Asyut
Ahmed Abbas, MD, 00201003385183, bmr90@hotmail.com
About this study
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
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
- Being tested
- Eosinophilic Cationic Protein biomarker
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eosinophilic Cationic Protein biomarkerDiagnostic test
3 ml blood for serum sample for estimation of Eosinophilic Cationic Protein biomarker level using ELISA
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Diagnostic Test: Eosinophilic Cationic Protein biomarker |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean difference in the level of Eosinophilic Cationic Protein biomarker in the two study groups
measurement by ELISA
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start1 Aug 2019
- Primary completionSep 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04008017
- Sponsor's protocol ID
- COPD-ECP
- Status last verified
- Apr 2021
- First submitted
- 2 Jul 2019
- Last updated
- 23 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04008017
- Acronym / sponsor ID
- COPD-ECP
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stable Chronic obstructive pulmonary disease | – | Diagnostic Test: Eosinophilic Cationic Protein biomarkerclinical features of Chronic obstructive pulmonary disease and associated spirometry compatible with the GOLD criteria (Forced expiratory volume 1/ Forced vital capacity <70%) post bronchodilator |
| acute exacerbation of Chronic obstructive pulmonary disease | – | Diagnostic Test: Eosinophilic Cationic Protein biomarkerpatients 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- clinical features of Chronic obstructive pulmonary disease
- spirometry compatible with the GOLD criteria (Forced expiratory volume 1/ Forced vital capacity <70%) post bronchodilator.
Key exclusion criteria (8 listed)
- Patients with bronchial asthma
- Asthma -Chronic obstructive pulmonary disease overlap syndrome
- Atopic patients
- Pneumothorax
- Congestive heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eosinophilic Cationic Protein biomarker3 ml blood for serum sample for estimation of Eosinophilic Cationic Protein biomarker level using ELISA | Diagnostic test | acute exacerbation of Chronic obstructive pulmonary disease, stable Chronic obstructive pulmonary disease |
Primary outcome
The mean difference in the level of Eosinophilic Cationic Protein biomarker in the two study groups
Time frame: 3 months
measurement by ELISA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alaa EL-Minshawy, MBBCh (00201128892117, alaa01194@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean difference in the level of Eosinophilic Cationic Protein biomarker in the two study groups (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2021.