Serum Interleukin 6 in Chronic Obstructive Pulmonary Disease

NCT ID: NCT05214508

Last Updated: 2022-01-28

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

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2020-11-30

Brief Summary

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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

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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)

Conditions

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Chronic Obstr Lung Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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COPD patient

COPD patients diagnosed based on spirometry, PFT and history

Group Type ACTIVE_COMPARATOR

interleukin 6

Intervention Type DIAGNOSTIC_TEST

assessment of serum IL-6 by ELISA

Control

Healthy volunteers

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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interleukin 6

assessment of serum IL-6 by ELISA

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beni-Suef University

OTHER

Sponsor Role lead

Responsible Party

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Fatma Gamal Mohamed

assisstant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Laila Anwar Sharawy

Role: STUDY_DIRECTOR

Beni Suef faculty of medicine

Locations

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Beni Suef university

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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faculty of medicine

Identifier Type: -

Identifier Source: org_study_id

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