CopdPhase 1NCT05718453
Assessment of Trace Elements, Systemic Inflammation and Electrolytes
A Phase 1 study testing Laboratory Tests in people with Copd, run by Egymedicalpedia at 1 site in Egypt.
Trial summary
COPD is one of the most common causes of health problems worldwide. It is a disease that is associated with several systemic features that affect its morbidity and mortality. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Copd
- What is being tested?
- Laboratory Tests
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2019to 15 Dec 2019
- Phase
- Phase 1
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- COPD patients
Who cannot join
- Patients with Cardiovascular diseases,
- diabetes mellitus,
- chronic kidney disease,
- chronic liver disease,
- collagen vascular diseases,
- cancer,
- currently smoking,
- current pneumonia or inflammation, or refused to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Trace Elements, Systemic Inflammation and Electrolytes in Patients With Chronic Obstructive Pulmonary Disease
COPD is one of the most common causes of health problems worldwide. It is a disease that is associated with several systemic features that affect its morbidity and mortality.
Read the detailed description
The most prominent features of COPD are systemic inflammation and oxidative stress. There is growing interest in establishing the significance of systemic inflammatory biomarkers in COPD patients, as they could be useful in evaluating exacerbations, monitoring disease progression, and evaluating treatment outcomes.
C-reactive protein (CRP) is a biomarker for systemic inflammation, produced mostly by hepatocytes in response to tissue injury or inflammation.
Tumor necrosis factor - alpha (TNF-α) is a key modulator of the immune system's response to infection. At the sites of inflammation, this cytokine regulates the function of poly-morphs and lymphocytes, with essentially protective benefits for the host. Increased TNF-α production may enhance an injury process locally and also elevated circulating levels may have negative systemic consequences.
Trace elements are hypothesized to play a role in the pathogenesis of many diseases, either directly or indirectly. Trace elements play an important function in the inhibition and activation of enzyme processes .
Zinc, for example, is a co-factor for various enzymes and is important for cell membrane stability, protein synthesis, proper tissue growth, and nucleic acid metabolism.
Severity of COPD exacerbation is associated with increased levels of copper (Cu) and zinc (Zn).
Patients with COPD are liable for various electrolyte derangements, especially during exacerbations. Hyponatremia is typically observed in the final stages of COPD. Hypokalemia may also occur independently or concomitantly with hyponatremia, and because magnesium plays a role in muscle tone, a drop in magnesium levels in COPD is a component that reduces respiratory muscle function and causes muscle fatigue.
- Conditions
- Copd
- Being tested
- Laboratory Tests
- Keywords
- COPD, Biomarkers, Trace elements, Electrolytes
- 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.
Laboratory TestsCombination product
Measurement of serum level of CRP, tumor necrosis factor, zinc, copper, potassium, sodium, and magnesium in patients with stable COPD and during exacerbation.
| Study group | Role | What they receive |
|---|---|---|
| COPD patients | Active comparator | It is about 60 patients with Stable COPD Receives: Combination Product: Laboratory Tests |
| Acute exacerbation COPD | Active comparator | It is about 40 patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD). Receives: Combination Product: Laboratory Tests |
| healthy controls | Placebo comparator | It is about 40 healthy controls were included in the study Receives: Combination Product: Laboratory Tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the pain resulted in COPD
The Pain was measured by using the visual analogue score (VAS) as Total scores vary from 0 to 10 in this method, with a higher score indicating more severe pain
Measured: from baseline to 72 hours
Number of participants with abnormal laboratory test results
he study tried to assess some Laboratory Tests in blood and comparing the level of their results in patients with stable and patients with exacerbation of theirs disease and aslo comparing their values between patients who needed and those who did not need mechanical ventilation
Measured: from baseline to 48 hours after the taking blood samle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start1 Jun 2019
- Primary completion1 Dec 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CopdStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Measurement of serum level of CRP, tumor necrosis factor, zinc, copper, potassium, sodium, and magnesium in patients with stable COPD and during exacerbation.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egymedicalpedia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mohammad O Abdel Aziz, Professor, Study director, Department of Internal medicine Minia university, Minia, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05718453
- Sponsor's protocol ID
- Rasha Abdelfattah
- Status last verified
- Feb 2023
- First submitted
- 4 Jan 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Trace Elements, Systemic Inflammation and Electrolytes in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT05718453
- Acronym / sponsor ID
- Rasha Abdelfattah
- Conditions
- Copd
- Keywords
- COPD, Biomarkers, Trace elements, Electrolytes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- EgymedicalpediaIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 8 Feb 2023 (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.
COPD is one of the most common causes of health problems worldwide. It is a disease that is associated with several systemic features that affect its morbidity and mortality.
Detailed description
The most prominent features of COPD are systemic inflammation and oxidative stress. There is growing interest in establishing the significance of systemic inflammatory biomarkers in COPD patients, as they could be useful in evaluating exacerbations, monitoring disease progression, and evaluating treatment outcomes.
C-reactive protein (CRP) is a biomarker for systemic inflammation, produced mostly by hepatocytes in response to tissue injury or inflammation.
Tumor necrosis factor - alpha (TNF-α) is a key modulator of the immune system's response to infection. At the sites of inflammation, this cytokine regulates the function of poly-morphs and lymphocytes, with essentially protective benefits for the host. Increased TNF-α production may enhance an injury process locally and also elevated circulating levels may have negative systemic consequences.
Trace elements are hypothesized to play a role in the pathogenesis of many diseases, either directly or indirectly. Trace elements play an important function in the inhibition and activation of enzyme processes .
Zinc, for example, is a co-factor for various enzymes and is important for cell membrane stability, protein synthesis, proper tissue growth, and nucleic acid metabolism.
Severity of COPD exacerbation is associated with increased levels of copper (Cu) and zinc (Zn).
Patients with COPD are liable for various electrolyte derangements, especially during exacerbations. Hyponatremia is typically observed in the final stages of COPD. Hypokalemia may also occur independently or concomitantly with hyponatremia, and because magnesium plays a role in muscle tone, a drop in magnesium levels in COPD is a component that reduces respiratory muscle function and causes muscle fatigue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Measurement of serum level of CRP, tumor necrosis factor, zinc, copper, potassium, sodium, and magnesium in patients with stable COPD and during exacerbation.
| Arm | Type | Receives |
|---|---|---|
| COPD patients | Active comparator | Combination Product: Laboratory TestsIt is about 60 patients with Stable COPD |
| Acute exacerbation COPD | Active comparator | Combination Product: Laboratory TestsIt is about 40 patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD). |
| healthy controls | Placebo comparator | Combination Product: Laboratory TestsIt is about 40 healthy controls were included in the study |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- COPD patients
Key exclusion criteria (8 listed)
- Patients with Cardiovascular diseases,
- diabetes mellitus,
- chronic kidney disease,
- chronic liver disease,
- collagen vascular diseases,
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 |
|---|---|---|
| Laboratory TestsMeasurement of serum level of CRP, tumor necrosis factor, zinc, copper, potassium, sodium, and magnesium in patients with stable COPD and during exacerbation. | Combination product | Acute exacerbation COPD, COPD patients, healthy controls |
Primary outcome
Assessment of the pain resulted in COPD
Time frame: from baseline to 72 hours
The Pain was measured by using the visual analogue score (VAS) as Total scores vary from 0 to 10 in this method, with a higher score indicating more severe pain
Number of participants with abnormal laboratory test results
Time frame: from baseline to 48 hours after the taking blood samle
he study tried to assess some Laboratory Tests in blood and comparing the level of their results in patients with stable and patients with exacerbation of theirs disease and aslo comparing their values between patients who needed and those who did not need mechanical ventilation
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 8 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Copd
Enrolling by invitationObservational study
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Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruitingPhase 3
The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
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RecruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
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Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia
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.
Mohammad O Abdel Aziz, Professor study director
Department of Internal medicine Minia university, Minia, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Laboratory Tests in people with Copd, run by Egymedicalpedia 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 1 inclusion and 8 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 8 Feb 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Assessment of the pain resulted in COPD (time frame: from baseline to 72 hours). The study lists 2 primary outcomes in all. 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 8 Feb 2023.