NCT05214508

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 28, 2022

Completed
Last Updated

January 28, 2022

Status Verified

January 1, 2022

Enrollment Period

8 months

First QC Date

January 14, 2022

Last Update Submit

January 27, 2022

Conditions

Chronic Obstr Lung Disease

Outcome Measures

Primary Outcomes (1)

  • measure level of IL-6

    using ELISA

    9 monthes

Study Arms (2)

COPD patient

ACTIVE COMPARATOR

COPD patients diagnosed based on spirometry, PFT and history

Diagnostic Test: interleukin 6

Control

NO INTERVENTION

Healthy volunteers

Interventions

interleukin 6DIAGNOSTIC_TEST

assessment of serum IL-6 by ELISA

COPD patient

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Any patient with systemic inflammation as
  • Bronchial asthma,
  • rheumatoid arthritis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beni Suef university

Cairo, 62511, Egypt

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Laila Anwar Sharawy

    Beni Suef faculty of medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assisstant lecturer

Study Record Dates

First Submitted

January 14, 2022

First Posted

January 28, 2022

Study Start

March 1, 2020

Primary Completion

November 1, 2020

Study Completion

November 30, 2020

Last Updated

January 28, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will share

Available for all researchers

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
3/2022 for 2 years
Access Criteria
All

Locations

EG(1)