Serum Interleukin 6 in Chronic Obstructive Pulmonary Disease

Sponsor

Beni-Suef University (Other)

Overall Status

Completed

CT.gov ID

NCT05214508

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstr Lung Disease	Diagnostic Test: interleukin 6	N/A

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)

Study Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Mar 1, 2020

Actual Primary Completion Date :

Nov 1, 2020

Actual Study Completion Date :

Nov 30, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

measure level of IL-6 [9 monthes]
using ELISA

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beni Suef university	Cairo		Egypt	62511

Sponsors and Collaborators

Beni-Suef University

Investigators

Study Director: Laila Anwar Sharawy, Beni Suef faculty of medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fatma Gamal Mohamed, assisstant lecturer, Beni-Suef University

ClinicalTrials.gov Identifier:

NCT05214508

Other Study ID Numbers:

faculty of medicine

First Posted:

Jan 28, 2022

Last Update Posted:

Jan 28, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lung Diseases

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Jan 28, 2022