Chronic Obstr Lung DiseaseNCT05214508
Serum Interleukin 6 in Chronic Obstructive Pulmonary Disease
A study testing interleukin 6 in people with Chronic Obstr Lung Disease, run by Beni-Suef University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstr Lung Disease
- What is being tested?
- interleukin 6
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2020to 30 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 1- Any patient with systemic inflammation as
- Bronchial asthma,
- rheumatoid arthritis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serum Interleukin 6 in Chronic Obstructive Pulmonary Disease Patients and Its Relation to Severity and Acute Exacerbation
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
- 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)
- Conditions
- Chronic Obstr Lung Disease
- Being tested
- interleukin 6
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interleukin 6Diagnostic test
assessment of serum IL-6 by ELISA
| Study group | Role | What they receive |
|---|---|---|
| COPD patient | Active comparator | COPD patients diagnosed based on spirometry, PFT and history Receives: Diagnostic Test: interleukin 6 |
| Control | No intervention | Healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure level of IL-6
using ELISA
Measured: 9 monthes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start1 Mar 2020
- Primary completion1 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstr Lung DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Gamal Mohamed, Beni-Suef University
- Investigators
- Laila Anwar Sharawy, Study director, Beni Suef faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05214508
- Sponsor's protocol ID
- faculty of medicine
- Status last verified
- Jan 2022
- First submitted
- 14 Jan 2022
- Last updated
- 28 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Available for all researchers
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Interleukin 6 in Chronic Obstructive Pulmonary Disease Patients and Its Relation to Severity and Acute Exacerbation
- ClinicalTrials.gov ID
- NCT05214508
- Acronym / sponsor ID
- faculty of medicine
- Conditions
- Chronic Obstr Lung Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD patient | Active comparator | Diagnostic Test: interleukin 6COPD patients diagnosed based on spirometry, PFT and history |
| Control | No intervention | –Healthy volunteers |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 1- Any patient with systemic inflammation as
- Bronchial asthma,
- rheumatoid arthritis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interleukin 6assessment of serum IL-6 by ELISA | Diagnostic test | COPD patient |
Primary outcome
measure level of IL-6
Time frame: 9 monthes
using ELISA
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- Individual participant dataSharing planned: Yes. Available for all researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laila Anwar Sharawy study director
Beni Suef faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interleukin 6 in people with Chronic Obstr Lung Disease, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure level of IL-6 (time frame: 9 monthes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2022.