Impact of A. Lumbricoides on Pulmonary Aspergillosis Development

Study Overview
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Brief Summary
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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.

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

Conditions
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COPD Exacerbation Acute, Ascaris Lumbricoides Infection, Chronic Pulmonary Aspergillosis

Intervention / Treatment
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* Diagnostic Test: Interleukin-1B
* Diagnostic Test: Interleukin-4
* Diagnostic Test: Interleukin-6
* Diagnostic Test: tumor necrosis factor - a
* Diagnostic Test: interferon- gamma


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: COPD patients without any comorbidities<br> | Diagnostic Test: Interleukin-1B<br>* Level of serum interleukin-1B will be detected<br>Diagnostic Test: Interleukin-4<br>* Level of serum interleukin-4 will be detected<br>Diagnostic Test: Interleukin-6<br>* Level of serum interleukin-4 will be detected<br>Diagnostic Test: tumor necrosis factor - a<br>* Level of serum tumor necrosis factor - a will be detected<br>Diagnostic Test: interferon- gamma<br>* Level of serum interferon- gamma will be detected<br>|
| Active Comparator: COPD patients with chronic pulmonary aspergillosis<br> | Diagnostic Test: Interleukin-1B<br>* Level of serum interleukin-1B will be detected<br>Diagnostic Test: Interleukin-4<br>* Level of serum interleukin-4 will be detected<br>Diagnostic Test: Interleukin-6<br>* Level of serum interleukin-4 will be detected<br>Diagnostic Test: tumor necrosis factor - a<br>* Level of serum tumor necrosis factor - a will be detected<br>Diagnostic Test: interferon- gamma<br>* Level of serum interferon- gamma will be detected<br>|
| Active Comparator: COPD patients with ascariasis<br> | Diagnostic Test: Interleukin-1B<br>* Level of serum interleukin-1B will be detected<br>Diagnostic Test: Interleukin-4<br>* Level of serum interleukin-4 will be detected<br>Diagnostic Test: Interleukin-6<br>* Level of serum interleukin-4 will be detected<br>Diagnostic Test: tumor necrosis factor - a<br>* Level of serum tumor necrosis factor - a will be detected<br>Diagnostic Test: interferon- gamma<br>* Level of serum interferon- gamma will be detected<br>|
| Active Comparator: COPD patients with chronic pulmonary aspergillosis and ascariasis<br> | Diagnostic Test: Interleukin-1B<br>* Level of serum interleukin-1B will be detected<br>Diagnostic Test: Interleukin-4<br>* Level of serum interleukin-4 will be detected<br>Diagnostic Test: Interleukin-6<br>* Level of serum interleukin-4 will be detected<br>Diagnostic Test: tumor necrosis factor - a<br>* Level of serum tumor necrosis factor - a will be detected<br>Diagnostic Test: interferon- gamma<br>* Level of serum interferon- gamma will be detected<br>|
| Active Comparator: healthy control<br> | Diagnostic Test: Interleukin-1B<br>* Level of serum interleukin-1B will be detected<br>Diagnostic Test: Interleukin-4<br>* Level of serum interleukin-4 will be detected<br>Diagnostic Test: Interleukin-6<br>* Level of serum interleukin-4 will be detected<br>Diagnostic Test: tumor necrosis factor - a<br>* Level of serum tumor necrosis factor - a will be detected<br>Diagnostic Test: interferon- gamma<br>* Level of serum interferon- gamma will be detected<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, aspergillosis, ascariasis, cytokines, helminths