Protocol TARC-ABPA

Nantes University Hospital (NUH)

Status: Completed

Conditions: Allergic Broncho-Pulmonary Aspergillosis

Treatments: Other: Study of predictive factors

Study type: Interventional

Funder types: Other

Identifiers

NCT01710930

RC11_0158

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

29 participants in 1 patient group

Study of predictive factors

Experimental group

Treatment:

Other: Study of predictive factors