Clinical Trial: Protocol TARC-ABPA

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Interest of TARC Serum Marker for Follow-up of Patients With Allergic Broncho-Pulmonary Aspergillosis (ABPA), Excluding Cystic Fibrosis

Brief Summary:

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 :

  1. To investigate if induced sputum eosinophils count (compared to baseline) is associated with the occurrence of exacerbations.
  2. To examine if the exhaled NO (compared to a baseline) is associated with the occurrence of exacerbations.
  3. To investigate if activation of circulating T cells (compared to a baseline) is associated with the occurrence of exacerbations.
  4. To examine if the rate of specific Asp f IgG measured by ELISA (compared to a baseline) is associated with the occurrence of exacerbations.
  5. 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).
  6. 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.
  7. To establish if some of the clinical, functional or biological data studied are associated with the frequency of exacerbations.

Detailed Summary:
Sponsor: Nantes University Hospital

Current Primary Outcome: 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).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: Nantes University Hospital

Dates:
Date Received: October 15, 2012
Date Started: July 2012
Date Completion: November 2017
Last Updated: February 19, 2016
Last Verified: February 2016