Impact of A. Lumbricoides on Pulmonary Aspergillosis Development

NCT05783544 — Not applicable, Unknown, 200 participants, Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan

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Role of A. Lumbricoides in the Development of Pulmonary Aspergillosis in Chronic Obstructive Pulmonary Disease Patients

Registry	NCT05783544
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: triple, prevention
Enrollment	200 (Estimated)
Sponsor	Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan (Other gov)
Conditions	COPD Exacerbation Acute, Ascaris Lumbricoides Infection, Chronic Pulmonary Aspergillosis
Interventions	Interleukin-1B, Interleukin-4, Interleukin-6, tumor necrosis factor - a, interferon- gamma (Diagnostic test)
Dates	start 2015-05-01, primary completion 2025-12-31 (estimated), completion 2025-12-31 (estimated), first posted 2023-03-24, last updated 2023-08-01
Locations	1 site in Uzbekistan

-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.

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+Arms and interventions

Arm	Type	Interventions
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

Interleukin-1B (Diagnostic test): Level of serum interleukin-1B will be detected
Interleukin-4 (Diagnostic test): Level of serum interleukin-4 will be detected
Interleukin-6 (Diagnostic test): Level of serum interleukin-4 will be detected
tumor necrosis factor - a (Diagnostic test): Level of serum tumor necrosis factor - a will be detected
interferon- gamma (Diagnostic test): Level of serum interferon- gamma will be detected

+Outcome measures

Primary outcomes

Serum interleukin-1B levels in COPD patients and controls [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 [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 [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 [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 [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 [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.

Secondary outcomes

Rate of ascariasis infestation among COPD patients and controls [up to 12 months]: The frequency of ascariasis infestation among COPD patients with and without pulmonary aspergillosis, as well as healthy individuals, will be assessed.

+Eligibility

Sex: All, ages: 30 Years to 100 Years, accepts healthy volunteers

Inclusion Criteria:

* COPD patients
* COPD patients with aspergillosis
* COPD patients with ascariasis
* COPD patients with mix-infection
* Healthy individuals (controls)

Exclusion Criteria:

* COPD patients with other autoimmune diseases
* COPD patients with oncological diseases
* COPD patients with other co-infections

+Locations (1)

Facility	City	Country	Status
Research institute of epidemiology, microbiology and infectious diseases	Tashkent, Uchtepa	Uzbekistan	Recruiting