An interventional study of Study of predictive factors in Allergic Broncho-Pulmonary Aspergillosis, sponsored by Nantes University Hospital. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-06.
Sponsored by Nantes University Hospital · Not applicable, Interventional, and Diagnostic
The main objective of this study is to determine if a doubling of serum TARC (compared to baseline) is associated with the occurrence of exacerbations of ABPA.
The secondary objectives of the study are :
201 studies on the registry are indexed under Aspergillosis; 22 are open to participants now.
This study's enrollment of 29 is below the median of 50 across 106 interventional studies indexed under Aspergillosis.
Browse Aspergillosis studies →Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.
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Pre-inclusion criteria :
Inclusion criteria :
This inclusion will be definitive in V1, if :
If patient could not be included, it will be possible to re-screen him for the study, provided he meets the pre-inclusion and inclusion criteria. In this case, a new V0 will be scheduled at least 3 months after the first V0.
Exclusion criteria :
Other: Study of predictive factors
Phase 1 : Inclusion of patients (V0) : In the case of a participation agreement, data on age, profession, previous history, history of the disease and current treatments will be collected. Different tests will be performed at this visit. Phase 2 : Determination of the baseline (V1) : Patients will be reviewed one month after V0 (V1). In the absence of exacerbation between V0 and V1, the examinations performed in routine practice will be used to determine the basic state of biological parameters of interest. During this visit, different tests will be performed. Phase 3 : Quarterly monitoring of patients (V2-V9) : Patients will be followed every three months for 2 years (V2-V9).
The rate of serum TARC
The rate of serum TARC will be measured by ELISA and expressed in pg / ml.Doubling of TARC rate compared between baseline (V1) and exacerbations is the primary endpoint (qualitative binary).
Induced sputum eosinophils count
Increase in induced sputum eosinophils count assessed by cytology between baseline visit (V1) and the visit(s) in exacerbation.
The rate of Exhaled NO(FeNO50)
Increase in exhaled NO (FeNO50) between baseline visit (V1) and the visit (s) in exacerbation.
The rate of circulating T cells
Increase in circulating T cells activation, measured by the rate of Th1, Th2, Th17, Treg lymphocytes by flow cytometry before and after specific Asp f. stimulation between baseline visit (V1) and the visit (s) in exacerbation.
The rate of Aspf. specific serum IgG
Increase of Aspf. specific serum IgG, measured by ELISA between baseline visit (V1) and the visit (s) in exacerbation
Correlation between markers
Correlation between previous markers, TARC or specific IgE measured at baseline and the stage of the radiological stage of the disease evaluated at V1 (ABPA-S, ABPA-CB, ABPA-ORF).
Fungal exposure at home
Link of fungal exposure at home with exacerbation frequency and the stage of disease severity.
Clincal parameters
Link between the clinical parameters (sex, complex aspergillosis, smoking, body mass index, reached ENT associated (chronic rhinitis, sinonasal-polyposis)) and the frequency of exacerbations.
Biological parameters
Link between the biological parameters measured at stable state (V1) (total IgE, Asp fspecific IgE, Aspergillus precipitins) and the frequency of exacerbations.
Function parameters
Link between the function parameters measured at baseline state (FEV1 (in%), FVC (in%), compared RV / TLC, FeNO50) and the frequency of exacerbations.
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Nantes University Hospital