Protocol TARC-ABPA

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

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.

Study Overview

• Status: Completed
• Conditions: Allergic Broncho-Pulmonary Aspergillosis
• Intervention / Treatment: Other: Study of predictive factors

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Le Mans, France, 72037
    • CHU Le Mans
  • Nantes, France, 44093
    • Nantes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Pre-inclusion criteria :

• Major patients, of indifferent sex,
• Patients insured,
• Patients accepting to give, after information, their signed informed consent form,
• Patients affected by ABPA,
• Patients in remission without treatment, or stable under current treatment for at least 3 months.

Inclusion criteria :

This inclusion will be definitive in V1, if :

• The pre-inclusion criteria are respected,
• The patient has not presented any exacerbation since V0 thereby define a basic state.

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 :

• Minor patients,
• Adults under guardianship,
• Pregnant or lactating women,
• Patients unable to follow the protocol or to give consent,
• Patients with an infection of the lower respiratory tract in the 4 weeks preceding V0 or between V0 and V1,
• Patients who were hospitalized for respiratory problems in the 4 weeks preceding V0 or between V0 and V1,
• Patients with chronic inflammatory diseases unrelated to ABPA which could influence the results,
• Patients with cancer,
• Patients followed for cystic fibrosis defined by a positive sweat test,
• Patients with known compliance problems identified prior to the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description
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

Outcome Measure	Measure Description
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.

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Anaïs PIPET, Doctor, CHU de Nantes; Study Chair: Hakima OUKSEL, Doctor, University Hospital, Angers; Study Chair: François GOUPIL, Doctor, CH du Mans

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (ACTUAL): September 21, 2017
• Study Completion (ACTUAL): September 21, 2017

Study Registration Dates

• First Submitted: October 15, 2012
• First Submitted That Met QC Criteria: October 17, 2012
• First Posted (ESTIMATE): October 19, 2012

Study Record Updates

• Last Update Posted (ACTUAL): April 6, 2018
• Last Update Submitted That Met QC Criteria: April 5, 2018
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Allergic Broncho-Pulmonary Aspergillosis
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bacterial Infections and Mycoses; Respiratory Hypersensitivity; Hypersensitivity; Mycoses; Lung Diseases, Fungal; Aspergillosis; Pulmonary Aspergillosis; Aspergillosis, Allergic Bronchopulmonary
• Other Study ID Numbers: RC11_0158