Protocol TARC-ABPA

NCT ID: NCT01710930

Last Updated: 2018-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2017-09-21

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.

Conditions

Allergic Broncho-Pulmonary Aspergillosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Study of predictive factors

Group Type: EXPERIMENTAL

Study of predictive factors

Intervention Type: OTHER

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).

Interventions

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).

Intervention Type: OTHER

Eligibility Criteria

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.

This inclusion will be definitive in V1, if :

• The patient has not presented any exacerbation since V0 thereby define a basic state.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anaïs PIPET, Doctor

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Hakima OUKSEL, Doctor

Role: STUDY_CHAIR

University Hospital, Angers

François GOUPIL, Doctor

Role: STUDY_CHAIR

CH du Mans

Locations

CHU Le Mans

Le Mans, , France

Nantes University Hospital

Nantes, , France

Countries

France

Other Identifiers

RC11_0158

Identifier Type: -

Identifier Source: org_study_id