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CompletedNCT05214508Updated Jan 28, 2022

Serum Interleukin 6 in Chronic Obstructive Pulmonary Disease

An interventional study of interleukin 6 in Chronic Obstr Lung Disease, sponsored by Beni-Suef University. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2022-01-28.

Sponsored by Beni-Suef University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled Mar 2020, registered Jan 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Sex
All
01

Study 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.

Read the 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)

02

Conditions studied

  • Chronic Obstr Lung Disease
03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 90 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Beni-Suef University is the lead sponsor of 333 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

1- Any patient with systemic inflammation as

  1. Bronchial asthma,
  2. rheumatoid arthritis.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (actual)

Study arms

  • Active comparator
    COPD patient

    COPD patients diagnosed based on spirometry, PFT and history

    Diagnostic Test: interleukin 6

  • No intervention
    Control

    Healthy volunteers

Interventions

  • Diagnostic testinterleukin 6

    assessment of serum IL-6 by ELISA

06

What researchers measure

Primary outcomes

  1. measure level of IL-6

    using ELISA

    Time frame: 9 monthes

07

Study locations

1 site
  • Beni Suef university
    Cairo, 62511, Egypt
08

References and documents

Individual participant data

Plan to share: Yes — Available for all researchers

Supporting information: Study protocol, Sap

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05214508
Lead sponsor
Beni-Suef University
Responsible party
Fatma Gamal Mohamed (assisstant lecturer, Beni-Suef University) — Principal investigator
First posted
Jan 28, 2022
Start date
Mar 1, 2020
Primary completion
Nov 1, 2020
Completion
Nov 30, 2020
Last update
Jan 28, 2022

Study contacts

Laila Anwar Sharawy
study director · Beni Suef faculty of medicine

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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