Protocol TARC-ABPA - Full Text View

Purpose

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.

Condition	Intervention
Allergic Broncho-Pulmonary Aspergillosis	Other: Study of predictive factors


Study Type:	Interventional
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

Resource links provided by NLM:

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Aspergillosis

Genetic and Rare Diseases Information Center resources: Cystic Fibrosis Aspergillosis Allergic Bronchopulmonary Aspergillosis

U.S. FDA Resources

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:

The rate of serum TARC [ Designated as safety issue: No ]
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 [ Designated as safety issue: No ]
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) [ Designated as safety issue: No ]
Increase in exhaled NO (FeNO50) between baseline visit (V1) and the visit (s) in exacerbation.
The rate of circulating T cells [ Designated as safety issue: No ]
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 [ Designated as safety issue: No ]
Increase of Aspf. specific serum IgG, measured by ELISA between baseline visit (V1) and the visit (s) in exacerbation
Correlation between markers [ Designated as safety issue: No ]
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 [ Designated as safety issue: No ]
Link of fungal exposure at home with exacerbation frequency and the stage of disease severity.
Clincal parameters [ Designated as safety issue: No ]
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 [ Designated as safety issue: No ]
Link between the biological parameters measured at stable state (V1) (total IgE, Asp fspecific IgE, Aspergillus precipitins) and the frequency of exacerbations.
Function parameters [ Designated as safety issue: No ]
Link between the function parameters measured at baseline state (FEV1 (in%), FVC (in%), compared RV / TLC, FeNO50) and the frequency of exacerbations.


Enrollment:	29
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)

Arms	Assigned Interventions
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).

Arms

Assigned Interventions

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).

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01710930

Locations


France
CHU Angers
Angers, France, 49033
CHU Le Mans
Le Mans, France, 72037
Nantes University Hospital
Nantes, France, 44093

Sponsors and Collaborators

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

More Information


Responsible Party:	Nantes University Hospital
ClinicalTrials.gov Identifier:	NCT01710930 History of Changes
Other Study ID Numbers:	RC11-0158
Study First Received:	October 15, 2012
Last Updated:	February 19, 2016
Health Authority:	France : ANSM

Keywords provided by Nantes University Hospital:


Allergic Broncho-Pulmonary Aspergillosis

Additional relevant MeSH terms:


Aspergillosis, Allergic Bronchopulmonary Aspergillosis Pulmonary Aspergillosis Hyalohyphomycosis Dermatomycoses Skin Diseases, Infectious Infection Mycoses Skin Diseases	Lung Diseases, Fungal Lung Diseases Respiratory Tract Diseases Respiratory Hypersensitivity Respiratory Tract Infections Hypersensitivity, Immediate Hypersensitivity Immune System Diseases

ClinicalTrials.gov processed this record on September 27, 2016