Clinical trial NCT01710930: 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
Overall status: COMPLETED
Phase: NA
Conditions: Allergic Broncho-Pulmonary Aspergillosis
Keywords: Allergic Broncho-Pulmonary Aspergillosis
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2012-10-19
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: The rate of serum TARC
Secondary outcomes:
measure: Induced sputum eosinophils count
measure: The rate of Exhaled NO(FeNO50)
measure: The rate of circulating T cells
measure: The rate of Aspf. specific serum IgG
measure: Correlation between markers
measure: Fungal exposure at home
measure: Clincal parameters
measure: Biological parameters
measure: Function parameters
Other outcomes:
Locations:
city: Le Mans
country: France
facility: CHU Le Mans
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Anaïs PIPET, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Angers
name: Hakima OUKSEL, Doctor
role: STUDY_CHAIR
affiliation: CH du Mans
name: François GOUPIL, Doctor
role: STUDY_CHAIR
References: