In this study, we aim to characterize the immunological defect in patients with CPA as compared to patients with chronic obstructive pulmonary disease (COPD) without CPA on a functional, genetic, transcriptional and metabolic level.
ID
Source
Brief title
Condition
- Fungal infectious disorders
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters / endpoints are the differences between patients with
CPA and patients with COPD without CPA with regard to:
1. Cytokine production by peripheral blood mononuclear cells (PBMCs) in
response to different stimuli
2. Aspergillus fumigatus conidia killing capacity of polymorphonuclear
neutrophils (PMNs)
3. Single nucleotide polymorphisms (SNPs) in relevant genes involved in immune
recognition and / or immune response
4. RNA expression of relevant genes involved in immune recognition and / or
response in PBMCs
5. Metabolome pathways in macrophages (derived from CD14+ monocytes from
peripheral blood)
6. LC3-associated phagocytosis (LAP) by CD14+ monocytes
Depending on interim results, the investigators would like to retain the
possibility to decide to change the exact stimuli and read-out parameters
during the course of this research project, not leading to any changes in the
amount of blood drawn or burden in any other way for the patients.
To be able to correlate experimental results to clinical characteristics,
several clinical characteristics will be collected about the patients in coded
form (coded according to patient number in the electronic patient file),
including:
- Age
- Sex
- CPA subgroup (aspergilloma, Aspergillus nodule, CCPA, CFPA)
- Medication used
- HIV status, if known
Secondary outcome
Not applicable.
Background summary
Aspergillus species can cause a spectrum of disease in human hosts, ranging
from invasive infections to allergic disease (e.g., allergic bronchopulmonary
aspergillosis or ABPA). Which disease the host develops is largely dependent on
the immune response he or she mounts against this ubiquitous fungus. On the one
hand, invasive pulmonary aspergillosis (IPA) develops in (severely)
immunocompromised patients, whereas allergic bronchopulmonary aspergillosis
(ABPA) can develop in patients with underlying allergic disease. However,
chronic pulmonary aspergillosis (CPA) develops in apparently immunocompetent
patients or those with underlying anatomical/structural lung disease, raising
the question why some patients develop CPA, whereas others do not.
Study objective
In this study, we aim to characterize the immunological defect in patients with
CPA as compared to patients with chronic obstructive pulmonary disease (COPD)
without CPA on a functional, genetic, transcriptional and metabolic level.
Study design
Comparative in vitro / ex vivo functional, genetic, transcriptional and
metabolomics study.
Study burden and risks
Patients will be asked to donate 60 ml of peripheral venous blood once. The
risk and burden of this intervention is considered to be minimal, potentially
consisting of pain during collection of blood, vasovagal syncope during
collection of blood, possible haematoma formation after blood donation and the
slight risk of local infection of the puncture site.
Geert Grooteplein-Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein-Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
1. Adult patient (> 18 years of age)
2. Patient is able to give written informed consent
3. Diagnosis of CPA is established in the patient based on the diagnostic
criteria according to the ESCMID/ERS guidelines
Exclusion criteria
Known active infection with HIV
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL69716.091.19 |