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 :
- To investigate if induced sputum eosinophils count (compared to baseline) is associated with the occurrence of exacerbations.
- To examine if the exhaled NO (compared to a baseline) is associated with the occurrence of exacerbations.
- To investigate if activation of circulating T cells (compared to a baseline) is associated with the occurrence of exacerbations.
- To examine if the rate of specific Asp f IgG measured by ELISA (compared to a baseline) is associated with the occurrence of exacerbations.
- To determine if the variation of one of the markers above, TARC or Asp f specific IgE measured at baseline, may be associated with the radiological stage of the disease (ABPA-S, ABPA-CB, ABPA-ORF).
- To investigate if there is a link between fungal exposure at home (visually assessed by the contamination level and the proportion of positive samples for Asp. f) and the frequency of exacerbations.
- To establish if some of the clinical, functional or biological data studied are associated with the frequency of exacerbations.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Interest of TARC Serum Marker for Follow-up of Patients With Allergic Broncho-Pulmonary Aspergillosis (ABPA), Excluding Cystic Fibrosis|
- The rate of serum TARCThe 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 countIncrease 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 cellsIncrease 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 IgGIncrease of Aspf. specific serum IgG, measured by ELISA between baseline visit (V1) and the visit (s) in exacerbation
- Correlation between markersCorrelation 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 homeLink of fungal exposure at home with exacerbation frequency and the stage of disease severity.
- Clincal parametersLink between the clinical parameters (sex, complex aspergillosis, smoking, body mass index, reached ENT associated (chronic rhinitis, sinonasal-polyposis)) and the frequency of exacerbations.
- Biological parametersLink between the biological parameters measured at stable state (V1) (total IgE, Asp fspecific IgE, Aspergillus precipitins) and the frequency of exacerbations.
- Function parametersLink between the function parameters measured at baseline state (FEV1 (in%), FVC (in%), compared RV / TLC, FeNO50) and the frequency of exacerbations.
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||November 2017|
|Estimated Primary Completion Date:||November 2017 (Final data collection date for primary outcome measure)|
|Experimental: Study of predictive factors||
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01710930
|Angers, France, 49033|
|CHU Le Mans|
|Le Mans, France, 72037|
|Nantes University Hospital|
|Nantes, France, 44093|
|Principal Investigator:||Anaïs PIPET, Doctor||CHU de Nantes|
|Study Chair:||Hakima OUKSEL, Doctor||University Hospital, Angers|
|Study Chair:||François GOUPIL, Doctor||CH du Mans|