Protocol TARC-ABPA

Not Applicable

Completed

• Conditions: Allergic Broncho-Pulmonary Aspergillosis
• Interventions: Other: Study of predictive factors

• Registration Number: NCT01710930
• Lead Sponsor: Nantes University Hospital

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 Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-10-15
• Study First Submitted QC: 2012-10-17
• Study First Posted: 2012-10-19
• Primary Completion: 2017-09-21
• Study Completion: 2017-09-21
• Status Verified: 2017-11
• Last Update Submitted: 2018-04-05
• Last Update Posted: 2018-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study of predictive factors	Study of predictive factors	-

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures

Name	Time	Method
Biological parameters		Link between the biological parameters measured at stable state (V1) (total IgE, Asp fspecific IgE, Aspergillus precipitins) and the frequency of exacerbations.
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 Aspf. specific serum IgG		Increase of Aspf. specific serum IgG, measured by ELISA between baseline visit (V1) and the visit (s) in exacerbation
Function parameters		Link between the function parameters measured at baseline state (FEV1 (in%), FVC (in%), compared RV / TLC, FeNO50) and the frequency of exacerbations.
The rate of Exhaled NO(FeNO50)		Increase in exhaled NO (FeNO50) between baseline visit (V1) and the visit (s) in exacerbation.
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.
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.
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.

Trial Locations

Locations (2)

CHU Le Mans; 🇫🇷 Le Mans, France

Nantes University Hospital; 🇫🇷 Nantes, France