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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

200

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started May 2015

Longer than P75 for not_applicable

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

10.7 years study duration

Study Start

First participant enrolled

May 1, 2015

Completed

7.8 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2023

Completed

23 days until next milestone

First Posted

Study publicly available on registry

March 24, 2023

Completed

2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed

Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

10.7 years

First QC Date

March 1, 2023

Last Update Submit

July 27, 2023

Conditions

COPD Exacerbation Acute Ascaris Lumbricoides Infection Chronic Pulmonary Aspergillosis

Keywords

COPDaspergillosisascariasiscytokineshelminths

Outcome Measures

Primary Outcomes (6)

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 Outcomes (1)

Rate of ascariasis infestation among COPD patients and controls
up to 12 months