COPD Exacerbation AcuteNCT05783544
Impact of A. Lumbricoides on Pulmonary Aspergillosis Development
A study testing Interleukin-1B, Interleukin-4 and Interleukin-6 in people with COPD Exacerbation Acute and Ascaris Lumbricoides Infection, run by Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan at 1 site in Uzbekistan.
Trial summary
The prevalence of ascariasis in COPD patients with and without concomitant pulmonary aspergillosis and in controls will be determined. To assess the influence of ascaridosis on the development of pulmonary aspergillosis in COPD patients cytokine status of patients will be studied. Read more about this study
- Who is it for?
- Ages 30 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD Exacerbation Acute, Ascaris Lumbricoides Infection, Chronic Pulmonary Aspergillosis
- What is being tested?
- Interleukin-1B, Interleukin-4 and Interleukin-6
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUzbekistan
- Study dates
- 1 May 2015to 31 Dec 2025
- 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 30 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- COPD patients
- COPD patients with aspergillosis
- COPD patients with ascariasis
- COPD patients with mix-infection
- Healthy individuals (controls)
Who cannot join
- COPD patients with other autoimmune diseases
- COPD patients with oncological diseases
- COPD patients with other co-infections
Trial locations and contacts
1 site in 1 country.
Uzbekistan1 site, 1 recruiting
- Recruiting
Research institute of epidemiology, microbiology and infectious diseases
Tashkent, Uchtepa, 100133
About this study
Official title: Role of A. Lumbricoides in the Development of Pulmonary Aspergillosis in Chronic Obstructive Pulmonary Disease Patients
The prevalence of ascariasis in COPD patients with and without concomitant pulmonary aspergillosis and in controls will be determined. To assess the influence of ascaridosis on the development of pulmonary aspergillosis in COPD patients cytokine status of patients will be studied.
- Being tested
- Interleukin-1B, Interleukin-4, Interleukin-6, tumor necrosis factor - a, interferon- gamma
- Keywords
- COPD, aspergillosis, ascariasis, cytokines, helminths
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Aspergillosis, Ascariasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interleukin-1BDiagnostic test
Level of serum interleukin-1B will be detected
Interleukin-4Diagnostic test
Level of serum interleukin-4 will be detected
Interleukin-6Diagnostic test
Level of serum interleukin-4 will be detected
tumor necrosis factor - aDiagnostic test
Level of serum tumor necrosis factor - a will be detected
interferon- gammaDiagnostic test
Level of serum interferon- gamma will be detected
| Study group | Role | What they receive |
|---|---|---|
| COPD patients without any comorbidities | Active comparator | Not described Receives: Diagnostic Test: Interleukin-1B; Diagnostic Test: Interleukin-4; Diagnostic Test: Interleukin-6; Diagnostic Test: tumor necrosis factor - a; Diagnostic Test: interferon- gamma |
| COPD patients with chronic pulmonary aspergillosis | Active comparator | Not described Receives: Diagnostic Test: Interleukin-1B; Diagnostic Test: Interleukin-4; Diagnostic Test: Interleukin-6; Diagnostic Test: tumor necrosis factor - a; Diagnostic Test: interferon- gamma |
| COPD patients with ascariasis | Active comparator | Not described Receives: Diagnostic Test: Interleukin-1B; Diagnostic Test: Interleukin-4; Diagnostic Test: Interleukin-6; Diagnostic Test: tumor necrosis factor - a; Diagnostic Test: interferon- gamma |
| COPD patients with chronic pulmonary aspergillosis and ascariasis | Active comparator | Not described Receives: Diagnostic Test: Interleukin-1B; Diagnostic Test: Interleukin-4; Diagnostic Test: Interleukin-6; Diagnostic Test: tumor necrosis factor - a; Diagnostic Test: interferon- gamma |
| healthy control | Active comparator | Not described Receives: Diagnostic Test: Interleukin-1B; Diagnostic Test: Interleukin-4; Diagnostic Test: Interleukin-6; Diagnostic Test: tumor necrosis factor - a; Diagnostic Test: interferon- gamma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum interleukin-1B levels in COPD patients and controls
Serum interleukin-1B (pg/mL) levels will be measured in COPD patients without concomitant infection, COPD patients with pulmonary aspergillosis, COPD patients with ascariasis, COPD patients with ascariasis and pulmonary aspergillosis, and healthy individuals.
Measured: up to 12 months
Serum interleukin-4 levels in COPD patients and controls
Serum interleukin-4 (pg/mL) levels will be measured in COPD patients without concomitant infection, COPD patients with pulmonary aspergillosis, COPD patients with ascariasis, COPD patients with ascariasis and pulmonary aspergillosis, and healthy individuals.
Measured: up to 12 months
Serum interleukin-6 levels in COPD patients and controls
Serum interleukin-6 (pg/mL) levels will be measured in COPD patients without concomitant infection, COPD patients with pulmonary aspergillosis, COPD patients with ascariasis, COPD patients with ascariasis and pulmonary aspergillosis, and healthy individuals.
Measured: up to 12 months
Serum tumor necrosis factor-a levels in COPD patients and controls
Serum tumor necrosis factor-a (pg/mL) levels will be measured in COPD patients without concomitant infection, COPD patients with pulmonary aspergillosis, COPD patients with ascariasis, COPD patients with ascariasis and pulmonary aspergillosis, and healthy individuals.
Measured: up to 12 months
Serum interferon-gamma levels in COPD patients and controls
Serum interferon-gamma (pg/mL) levels will be measured in COPD patients without concomitant infection, COPD patients with pulmonary aspergillosis, COPD patients with ascariasis, COPD patients with ascariasis and pulmonary aspergillosis, and healthy individuals.
Measured: up to 12 months
Correlation between cytokine status with chronic pulmonary aspergilosis insidence rate in COPD patients with and without ascariasis
The correlation between serum interleukin-1B, interleukin-4, interleukin-6, tumor necrosis factor-a and interferon-y levels with chronic pulmonary aspergilosis insidence rate in COPD patients with and without ascariasis will be assessed.
Measured: up to 12 months
Secondary outcomes (1)
Rate of ascariasis infestation among COPD patients and controls
The frequency of ascariasis infestation among COPD patients with and without pulmonary aspergillosis, as well as healthy individuals, will be assessed.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start1 May 2015
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD Exacerbation AcuteStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Svetlana Osipova, MD, PhD, DS, Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05783544
- Sponsor's protocol ID
- 01032023
- Status last verified
- Jul 2023
- First submitted
- 1 Mar 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of A. Lumbricoides in the Development of Pulmonary Aspergillosis in Chronic Obstructive Pulmonary Disease Patients
- ClinicalTrials.gov ID
- NCT05783544
- Acronym / sponsor ID
- 01032023
- Keywords
- COPD, aspergillosis, ascariasis, cytokines, helminths
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Research Institute of Epidemiology, Microbiology and Infectious Diseases, UzbekistanOther government
- Study start
- 1 May 2015 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Mar 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.
The prevalence of ascariasis in COPD patients with and without concomitant pulmonary aspergillosis and in controls will be determined. To assess the influence of ascaridosis on the development of pulmonary aspergillosis in COPD patients cytokine status of patients will be studied.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| COPD patients without any comorbidities | Active comparator | Diagnostic Test: Interleukin-1B, Diagnostic Test: Interleukin-4, Diagnostic Test: Interleukin-6, Diagnostic Test: tumor necrosis factor - a, Diagnostic Test: interferon- gamma |
| COPD patients with chronic pulmonary aspergillosis | Active comparator | Diagnostic Test: Interleukin-1B, Diagnostic Test: Interleukin-4, Diagnostic Test: Interleukin-6, Diagnostic Test: tumor necrosis factor - a, Diagnostic Test: interferon- gamma |
| COPD patients with ascariasis | Active comparator | Diagnostic Test: Interleukin-1B, Diagnostic Test: Interleukin-4, Diagnostic Test: Interleukin-6, Diagnostic Test: tumor necrosis factor - a, Diagnostic Test: interferon- gamma |
| COPD patients with chronic pulmonary aspergillosis and ascariasis | Active comparator | Diagnostic Test: Interleukin-1B, Diagnostic Test: Interleukin-4, Diagnostic Test: Interleukin-6, Diagnostic Test: tumor necrosis factor - a, Diagnostic Test: interferon- gamma |
| healthy control | Active comparator | Diagnostic Test: Interleukin-1B, Diagnostic Test: Interleukin-4, Diagnostic Test: Interleukin-6, Diagnostic Test: tumor necrosis factor - a, Diagnostic Test: interferon- gamma |
Who may qualify
- Ages
- 30 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- COPD patients
- COPD patients with aspergillosis
- COPD patients with ascariasis
- COPD patients with mix-infection
- Healthy individuals (controls)
Key exclusion criteria (3 listed)
- COPD patients with other autoimmune diseases
- COPD patients with oncological diseases
- COPD patients with other co-infections
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-1BLevel of serum interleukin-1B will be detected | Diagnostic test | COPD patients with ascariasis, COPD patients with chronic pulmonary aspergillosis, COPD patients with chronic pulmonary aspergillosis and ascariasis, COPD patients without any comorbidities, healthy control |
| Interleukin-4Level of serum interleukin-4 will be detected | Diagnostic test | COPD patients with ascariasis, COPD patients with chronic pulmonary aspergillosis, COPD patients with chronic pulmonary aspergillosis and ascariasis, COPD patients without any comorbidities, healthy control |
| Interleukin-6Level of serum interleukin-4 will be detected | Diagnostic test | COPD patients with ascariasis, COPD patients with chronic pulmonary aspergillosis, COPD patients with chronic pulmonary aspergillosis and ascariasis, COPD patients without any comorbidities, healthy control |
| tumor necrosis factor - aLevel of serum tumor necrosis factor - a will be detected | Diagnostic test | COPD patients with ascariasis, COPD patients with chronic pulmonary aspergillosis, COPD patients with chronic pulmonary aspergillosis and ascariasis, COPD patients without any comorbidities, healthy control |
| interferon- gammaLevel of serum interferon- gamma will be detected | Diagnostic test | COPD patients with ascariasis, COPD patients with chronic pulmonary aspergillosis, COPD patients with chronic pulmonary aspergillosis and ascariasis, COPD patients without any comorbidities, healthy control |
Primary outcome
Serum interleukin-1B levels in COPD patients and controls
Time frame: up to 12 months
Serum interleukin-1B (pg/mL) levels will be measured in COPD patients without concomitant infection, COPD patients with pulmonary aspergillosis, COPD patients with ascariasis, COPD patients with ascariasis and pulmonary aspergillosis, and healthy individuals.
Serum interleukin-4 levels in COPD patients and controls
Time frame: up to 12 months
Serum interleukin-4 (pg/mL) levels will be measured in COPD patients without concomitant infection, COPD patients with pulmonary aspergillosis, COPD patients with ascariasis, COPD patients with ascariasis and pulmonary aspergillosis, and healthy individuals.
Serum interleukin-6 levels in COPD patients and controls
Time frame: up to 12 months
Serum interleukin-6 (pg/mL) levels will be measured in COPD patients without concomitant infection, COPD patients with pulmonary aspergillosis, COPD patients with ascariasis, COPD patients with ascariasis and pulmonary aspergillosis, and healthy individuals.
Serum tumor necrosis factor-a levels in COPD patients and controls
Time frame: up to 12 months
Serum tumor necrosis factor-a (pg/mL) levels will be measured in COPD patients without concomitant infection, COPD patients with pulmonary aspergillosis, COPD patients with ascariasis, COPD patients with ascariasis and pulmonary aspergillosis, and healthy individuals.
Serum interferon-gamma levels in COPD patients and controls
Time frame: up to 12 months
Serum interferon-gamma (pg/mL) levels will be measured in COPD patients without concomitant infection, COPD patients with pulmonary aspergillosis, COPD patients with ascariasis, COPD patients with ascariasis and pulmonary aspergillosis, and healthy individuals.
Correlation between cytokine status with chronic pulmonary aspergilosis insidence rate in COPD patients with and without ascariasis
Time frame: up to 12 months
The correlation between serum interleukin-1B, interleukin-4, interleukin-6, tumor necrosis factor-a and interferon-y levels with chronic pulmonary aspergilosis insidence rate in COPD patients with and without ascariasis will be assessed.
1 secondary outcome
Rate of ascariasis infestation among COPD patients and controls
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Individual participant dataSharing planned: No
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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.
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-1B, Interleukin-4 and Interleukin-6 in people with COPD Exacerbation Acute and Ascaris Lumbricoides Infection, run by Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan at 1 site in Uzbekistan.
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 5 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: status not confirmed, as of the sponsor's last update on 1 Aug 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 Uzbekistan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdurakhim Dr Toychiev, PhD (+998901358977, abdurahim1988@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum interleukin-1B levels in COPD patients and controls (time frame: up to 12 months). The study lists 6 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 1 Aug 2023.