Role of A. Lumbricoides in the Development of Pulmonary Aspergillosis in Chronic Obstructive Pulmonary Disease Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Serum tumor necrosis factor-a levels in COPD patients and controls
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
healthy control
Intervention: Interleukin-4 (Diagnostic Test)
COPD patients with chronic pulmonary aspergillosis
Intervention: Interleukin-4 (Diagnostic Test)
COPD patients with chronic pulmonary aspergillosis and ascariasis
Intervention: Interleukin-4 (Diagnostic Test)
healthy control
Intervention: Interleukin-6 (Diagnostic Test)
COPD patients with chronic pulmonary aspergillosis
Intervention: Interleukin-1B (Diagnostic Test)
COPD patients with chronic pulmonary aspergillosis and ascariasis
Intervention: Interleukin-1B (Diagnostic Test)
COPD patients with chronic pulmonary aspergillosis and ascariasis
Intervention: tumor necrosis factor - a (Diagnostic Test)
healthy control
Intervention: Interleukin-1B (Diagnostic Test)
healthy control
Intervention: interferon- gamma (Diagnostic Test)
healthy control
Intervention: tumor necrosis factor - a (Diagnostic Test)
COPD patients without any comorbidities
Intervention: Interleukin-1B (Diagnostic Test)
COPD patients without any comorbidities
Intervention: tumor necrosis factor - a (Diagnostic Test)
COPD patients with chronic pulmonary aspergillosis
Intervention: tumor necrosis factor - a (Diagnostic Test)
COPD patients with ascariasis
Intervention: Interleukin-1B (Diagnostic Test)
COPD patients with ascariasis
Intervention: tumor necrosis factor - a (Diagnostic Test)
COPD patients with chronic pulmonary aspergillosis and ascariasis
Intervention: Interleukin-6 (Diagnostic Test)
COPD patients with ascariasis
Intervention: interferon- gamma (Diagnostic Test)
COPD patients with ascariasis
Intervention: Interleukin-6 (Diagnostic Test)
COPD patients with ascariasis
Intervention: Interleukin-4 (Diagnostic Test)
COPD patients with chronic pulmonary aspergillosis
Intervention: interferon- gamma (Diagnostic Test)
COPD patients with chronic pulmonary aspergillosis
Intervention: Interleukin-6 (Diagnostic Test)
COPD patients without any comorbidities
Intervention: interferon- gamma (Diagnostic Test)
COPD patients without any comorbidities
Intervention: Interleukin-4 (Diagnostic Test)
COPD patients without any comorbidities
Intervention: Interleukin-6 (Diagnostic Test)
COPD patients with chronic pulmonary aspergillosis and ascariasis
Intervention: interferon- gamma (Diagnostic Test)
Outcomes
Primary Outcomes
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.
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.
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.
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.
Secondary Outcomes
- Rate of ascariasis infestation among COPD patients and controls(up to 12 months)
Investigators
Svetlana Osipova, MD, PhD, DS
Head of Department of Immunology of Parasitic and Fungal Diseases
Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan