Serum Interleukin 6 in Chronic Obstructive Pulmonary Disease

Serum Interleukin 6 in Chronic Obstructive Pulmonary Disease Patients and Its Relation to Severity and Acute Exacerbation

The aim of this study is to estimate level of IL 6 in COPD patients and its relation to COPD severity and acute exacerbation.

Study Overview

• Status: Completed
• Conditions: Chronic Obstr Lung Disease
• Intervention / Treatment: Diagnostic test: interleukin 6

Detailed Description

1. 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.
2. Thereafter, the detailed physical examination also had been carried out.
3. 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).
4. Labs including Complete blood count, urea, and serum creatinine ,ESR was done for all patients
5. Exercise capacity by six minutes' walk test.
6. Dyspnea score by MMRC score.
7. 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)

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 62511
    • Beni suef university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. All patients aged >40 years and <80 years, of both gender
2. Diagnosed to have COPD according to GOLD 2019 by spirometry
3. Given the consent for participation in the study

Exclusion Criteria:

1- Any patient with systemic inflammation as

1. Bronchial asthma,
2. rheumatoid arthritis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: COPD patient; COPD patients diagnosed based on spirometry, PFT and history	Diagnostic test: interleukin 6; assessment of serum IL-6 by ELISA
No Intervention: Control; Healthy volunteers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
measure level of IL-6	using ELISA	9 monthes

Collaborators and Investigators

• Sponsor: Beni-Suef University
• Investigators: Study Director: Laila Anwar Sharawy, Beni Suef faculty of medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): November 1, 2020
• Study Completion (Actual): November 30, 2020

Study Registration Dates

• First Submitted: January 14, 2022
• First Submitted That Met QC Criteria: January 27, 2022
• First Posted (Actual): January 28, 2022

Study Record Updates

• Last Update Posted (Actual): January 28, 2022
• Last Update Submitted That Met QC Criteria: January 27, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: Faculty of Medicine (Other Identifier: Thammasat University, Thailand)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Available for all researchers
• IPD Sharing Time Frame: 3/2022 for 2 years
• IPD Sharing Access Criteria: All
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No