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Protocol TARC-ABPA

Primary Purpose

Allergic Broncho-Pulmonary Aspergillosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Study of predictive factors
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Allergic Broncho-Pulmonary Aspergillosis focused on measuring Allergic Broncho-Pulmonary Aspergillosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU Le Mans
  • Nantes University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study of predictive factors

Arm Description

Outcomes

Primary Outcome Measures

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

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.

Full Information

First Posted
October 15, 2012
Last Updated
April 5, 2018
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01710930
Brief Title
Protocol TARC-ABPA
Official Title
Interest of TARC Serum Marker for Follow-up of Patients With Allergic Broncho-Pulmonary Aspergillosis (ABPA), Excluding Cystic Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
September 21, 2017 (Actual)
Study Completion Date
September 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 : 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Broncho-Pulmonary Aspergillosis
Keywords
Allergic Broncho-Pulmonary Aspergillosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study of predictive factors
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Study of predictive factors
Intervention Description
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).
Primary Outcome Measure Information:
Title
The rate of serum TARC
Description
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 Measure Information:
Title
Induced sputum eosinophils count
Description
Increase in induced sputum eosinophils count assessed by cytology between baseline visit (V1) and the visit(s) in exacerbation.
Title
The rate of Exhaled NO(FeNO50)
Description
Increase in exhaled NO (FeNO50) between baseline visit (V1) and the visit (s) in exacerbation.
Title
The rate of circulating T cells
Description
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.
Title
The rate of Aspf. specific serum IgG
Description
Increase of Aspf. specific serum IgG, measured by ELISA between baseline visit (V1) and the visit (s) in exacerbation
Title
Correlation between markers
Description
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).
Title
Fungal exposure at home
Description
Link of fungal exposure at home with exacerbation frequency and the stage of disease severity.
Title
Clincal parameters
Description
Link between the clinical parameters (sex, complex aspergillosis, smoking, body mass index, reached ENT associated (chronic rhinitis, sinonasal-polyposis)) and the frequency of exacerbations.
Title
Biological parameters
Description
Link between the biological parameters measured at stable state (V1) (total IgE, Asp fspecific IgE, Aspergillus precipitins) and the frequency of exacerbations.
Title
Function parameters
Description
Link between the function parameters measured at baseline state (FEV1 (in%), FVC (in%), compared RV / TLC, FeNO50) and the frequency of exacerbations.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anaïs PIPET, Doctor
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hakima OUKSEL, Doctor
Organizational Affiliation
University Hospital, Angers
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
François GOUPIL, Doctor
Organizational Affiliation
CH du Mans
Official's Role
Study Chair
Facility Information:
Facility Name
CHU Le Mans
City
Le Mans
ZIP/Postal Code
72037
Country
France
Facility Name
Nantes University Hospital
City
Nantes
ZIP/Postal Code
44093
Country
France

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