Serum Interleukin 6 in Chronic Obstructive Pulmonary Disease | NCT05214508

Studies
Serum Interleukin 6 in Chronic Obstructive Pulmonary Disease

NCT05214508

Sponsor

Beni-Suef University

Status

Completed

Last Update Posted

Jan 28, 2022Actual

Enrollment

90Actual

Phase

Not Applicable

Conditions

Chronic Obstr Lung Disease

Interventions

interleukin 6

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2020Actual

Primary Completion Date

Nov 1, 2020Actual

Completion Date

Nov 30, 2020Actual

First Submitted Date

Jan 14, 2022

First Submission Date that Met QC Criteria

Jan 27, 2022

First Posted Date

Jan 28, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2022

Last Update Posted Date

Jan 28, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
COPD patient	Active Comparator	COPD patients diagnosed based on spirometry, PFT and history	Diagnostic Test: interleukin 6
Control	No Intervention	Healthy volunteers

Interventions

Name	Type	Description	Arm Group Labels	Other Names
interleukin 6	Diagnostic Test	assessment of serum IL-6 by ELISA	COPD patient

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Laila Anwar Sharawy	Beni Suef faculty of medicine	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beni Suef university		Cairo		62511	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Available for all researchers

Types

Study Protocol
Statistical Analysis Plan (SAP)

Time Frame

3/2022 for 2 years

Access Criteria

All

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided