This trial is active, not recruiting.

Condition allergic broncho-pulmonary aspergillosis
Treatment study of predictive factors
Sponsor Nantes University Hospital
Start date July 2012
End date November 2017
Trial size 29 participants
Trial identifier NCT01710930, RC11-0158


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
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).

Primary Outcomes

The rate of serum TARC
time frame:

Secondary Outcomes

Induced sputum eosinophils count
time frame:
The rate of Exhaled NO(FeNO50)
time frame:
The rate of circulating T cells
time frame:
The rate of Aspf. specific serum IgG
time frame:
Correlation between markers
time frame:
Fungal exposure at home
time frame:
Clincal parameters
time frame:
Biological parameters
time frame:
Function parameters
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Interest of TARC Serum Marker for Follow-up of Patients With Allergic Broncho-Pulmonary Aspergillosis (ABPA), Excluding Cystic Fibrosis
Principal investigator Anaïs PIPET, Doctor
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Nantes University Hospital.