Impact of A. Lumbricoides on Pulmonary Aspergillosis Development

COPD Exacerbation Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05783544
• Other study ID #: 01032023
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2015
• Est. completion date: December 31, 2025

Study information

• Verified date: July 2023
• Source: Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan
• Contact: Abdurakhim Dr Toychiev, PhD
• Phone: +998901358977
• Email: abdurahim1988[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Aspergillosis
• Chronic Pulmonary Aspergillosis
• COPD Exacerbation Acute
• Pulmonary Aspergillosis

Intervention

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

Locations

Country	Name	City	State
Uzbekistan	Research institute of epidemiology, microbiology and infectious diseases	Tashkent	Uchtepa

Sponsors (1)

Lead Sponsor	Collaborator
Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan

Country where clinical trial is conducted

Uzbekistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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