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Protocol TARC-ABPA

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ClinicalTrials.gov Identifier: NCT01710930
Recruitment Status : Completed
First Posted : October 19, 2012
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):

October 15, 2012
October 19, 2012
November 14, 2017
July 2012
September 21, 2017   (Final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01710930 on ClinicalTrials.gov Archive Site
  • Induced sputum eosinophils count
    Increase in induced sputum eosinophils count assessed by cytology between baseline visit (V1) and the visit(s) in exacerbation.
  • The rate of Exhaled NO(FeNO50)
    Increase in exhaled NO (FeNO50) between baseline visit (V1) and the visit (s) in exacerbation.
  • The rate of circulating T cells
    Increase in circulating T cells activation, measured by the rate of Th1, Th2, Th17, Treg lymphocytes by flow cytometry before and after specific Asp f. stimulation between baseline visit (V1) and the visit (s) in exacerbation.
  • The rate of Aspf. specific serum IgG
    Increase of Aspf. specific serum IgG, measured by ELISA between baseline visit (V1) and the visit (s) in exacerbation
  • Correlation between markers
    Correlation between previous markers, TARC or specific IgE measured at baseline and the stage of the radiological stage of the disease evaluated at V1 (ABPA-S, ABPA-CB, ABPA-ORF).
  • Fungal exposure at home
    Link of fungal exposure at home with exacerbation frequency and the stage of disease severity.
  • Clincal parameters
    Link between the clinical parameters (sex, complex aspergillosis, smoking, body mass index, reached ENT associated (chronic rhinitis, sinonasal-polyposis)) and the frequency of exacerbations.
  • Biological parameters
    Link between the biological parameters measured at stable state (V1) (total IgE, Asp fspecific IgE, Aspergillus precipitins) and the frequency of exacerbations.
  • Function parameters
    Link between the function parameters measured at baseline state (FEV1 (in%), FVC (in%), compared RV / TLC, FeNO50) and the frequency of exacerbations.
Same as current
Not Provided
Not Provided
 
Protocol TARC-ABPA
Interest of TARC Serum Marker for Follow-up of Patients With Allergic Broncho-Pulmonary Aspergillosis (ABPA), Excluding Cystic Fibrosis

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.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Allergic Broncho-Pulmonary Aspergillosis
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).

Experimental: Study of predictive factors
Intervention: Other: Study of predictive factors
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
September 21, 2017
September 21, 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01710930
RC11_0158
Yes
Not Provided
Not Provided
Nantes University Hospital
Nantes University Hospital
Not Provided
Principal Investigator: Anaïs PIPET, Doctor CHU de Nantes
Study Chair: Hakima OUKSEL, Doctor University Hospital, Angers
Study Chair: François GOUPIL, Doctor CH du Mans
Nantes University Hospital
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP