Protocol TARC-ABPA

NCT01710930 | Completed DMC

• 1 other identifier: RC11_0158
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

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. 1.To investigate if induced sputum eosinophils count (compared to baseline) is associated with the occurrence of exacerbations.
2. 2.To examine if the exhaled NO (compared to a baseline) is associated with the occurrence of exacerbations.
3. 3.To investigate if activation of circulating T cells (compared to a baseline) is associated with the occurrence of exacerbations.
4. 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. 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. 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. 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

Keywords

Allergic Broncho-Pulmonary Aspergillosis

Outcome Measures

Primary Outcomes (1)

• The rate of serum TARC

  The rate of serum TARC will be measured by ELISA and expressed in pg / ml.Doubling of TARC rate compared between baseline (V1) and exacerbations is the primary endpoint (qualitative binary).

Secondary Outcomes (9)

• Induced sputum eosinophils count

• The rate of Exhaled NO(FeNO50)

• The rate of circulating T cells

• The rate of Aspf. specific serum IgG

• Correlation between markers

Study Arms (1)

Study of predictive factors

EXPERIMENTAL

Other: Study of predictive factors

Interventions

Study of predictive factors 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).

Study of predictive factors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (2)

CHU Le Mans

Le Mans, 72037, France

Location

Nantes University Hospital

Nantes, 44093, France

Location

Study Officials

• Anaïs PIPET, Doctor

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

• Hakima OUKSEL, Doctor

  University Hospital, Angers

  STUDY CHAIR

• François GOUPIL, Doctor

  CH du Mans

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2012
• First Posted: October 19, 2012
• Study Start: July 1, 2012
• Primary Completion: September 21, 2017
• Study Completion: September 21, 2017
• Last Updated: April 6, 2018

Record last verified: 2017-11

Locations

FR (2)