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Protocol TARC-ABPA

NCT01710930 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2018-04-06

No results posted yet for this study

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.

Conditions

  • Allergic Broncho-Pulmonary Aspergillosis

Interventions

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).

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • Anaïs PIPET, Doctor · Nantes University Hospital

  • Hakima OUKSEL, Doctor · University Hospital, Angers

  • François GOUPIL, Doctor · CH du Mans

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2017-09-21
Completion
2017-09-21

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01710930 on ClinicalTrials.gov