Serum Interleukin 6 in Chronic Obstructive Pulmonary Disease
Primary Purpose
Chronic Obstr Lung Disease
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
interleukin 6
Sponsored by
About this trial
This is an interventional diagnostic trial for Chronic Obstr Lung Disease
Eligibility Criteria
Inclusion Criteria:
- All patients aged >40 years and <80 years, of both gender
- Diagnosed to have COPD according to GOLD 2019 by spirometry
- Given the consent for participation in the study
Exclusion Criteria:
1- Any patient with systemic inflammation as
- Bronchial asthma,
- rheumatoid arthritis.
Sites / Locations
- Beni Suef university
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
COPD patient
Control
Arm Description
COPD patients diagnosed based on spirometry, PFT and history
Healthy volunteers
Outcomes
Primary Outcome Measures
measure level of IL-6
using ELISA
Secondary Outcome Measures
Full Information
NCT ID
NCT05214508
First Posted
January 14, 2022
Last Updated
January 27, 2022
Sponsor
Beni-Suef University
1. Study Identification
Unique Protocol Identification Number
NCT05214508
Brief Title
Serum Interleukin 6 in Chronic Obstructive Pulmonary Disease
Official Title
Serum Interleukin 6 in Chronic Obstructive Pulmonary Disease Patients and Its Relation to Severity and Acute Exacerbation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
November 1, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beni-Suef University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of this study is to estimate level of IL 6 in COPD patients and its relation to COPD severity and acute exacerbation.
Detailed Description
A detailed clinical history was be carried out for every patient. In the clinical history, duration of COPD with a history of exacerbation and treatment will be elicited. History of the presence of risk factors such as smoking, exposure to fumes (biomass), and the presence of any other chronic disease were be inquired.
Thereafter, the detailed physical examination also had been carried out.
Pulmonary function test was performed by master screen NO : 781040 (care fusion) Measurements were obtained for FVC,FEV1,Ratio between them, PEF,FEF25%,FEF50% ,and FEF75% (The readings for FEV1 and Ratio were the ones included in the statistical analysis as indices for obstructive pattern of respiration).
Labs including Complete blood count, urea, and serum creatinine ,ESR was done for all patients
Exercise capacity by six minutes' walk test.
Dyspnea score by MMRC score.
Health state assessment by CAT score
3- 8- Determination of IL 6 serum levels. by sandwich enzyme-linked immunosorbent assay (ELISA). The detection range (0.2 ng/L- 8ng/L)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstr Lung Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COPD patient
Arm Type
Active Comparator
Arm Description
COPD patients diagnosed based on spirometry, PFT and history
Arm Title
Control
Arm Type
No Intervention
Arm Description
Healthy volunteers
Intervention Type
Diagnostic Test
Intervention Name(s)
interleukin 6
Intervention Description
assessment of serum IL-6 by ELISA
Primary Outcome Measure Information:
Title
measure level of IL-6
Description
using ELISA
Time Frame
9 monthes
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All patients aged >40 years and <80 years, of both gender
Diagnosed to have COPD according to GOLD 2019 by spirometry
Given the consent for participation in the study
Exclusion Criteria:
1- Any patient with systemic inflammation as
Bronchial asthma,
rheumatoid arthritis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laila Anwar Sharawy
Organizational Affiliation
Beni Suef faculty of medicine
Official's Role
Study Director
Facility Information:
Facility Name
Beni Suef university
City
Cairo
ZIP/Postal Code
62511
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Available for all researchers
IPD Sharing Time Frame
3/2022 for 2 years
IPD Sharing Access Criteria
All
Learn more about this trial
Serum Interleukin 6 in Chronic Obstructive Pulmonary Disease
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