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Serum Interleukin 6 in Chronic Obstructive Pulmonary Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05214508
Recruitment Status : Completed
First Posted : January 28, 2022
Last Update Posted : January 28, 2022
Sponsor:
Information provided by (Responsible Party):
Fatma Gamal Mohamed, Beni-Suef University

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 Not Applicable

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)

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Study Type : Interventional  (Clinical Trial)
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 : March 1, 2020
Actual Primary Completion Date : November 1, 2020
Actual Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

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



Primary Outcome Measures :
  1. measure level of IL-6 [ Time Frame: 9 monthes ]
    using ELISA



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05214508


Locations
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Egypt
Beni Suef university
Cairo, Egypt, 62511
Sponsors and Collaborators
Beni-Suef University
Investigators
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Study Director: Laila Anwar Sharawy Beni Suef faculty of medicine
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Responsible Party: Fatma Gamal Mohamed, assisstant lecturer, Beni-Suef University
ClinicalTrials.gov Identifier: NCT05214508    
Other Study ID Numbers: faculty of medicine
First Posted: January 28, 2022    Key Record Dates
Last Update Posted: January 28, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Available for all researchers
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 3/2022 for 2 years
Access Criteria: All

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases