CClinicalTrials.gg
TerminatedNCT02550041Updated May 9, 2019

Analysis T Cells Response for Identification of Aspergillus Bronchitis With Cystic Fibrosis Patients

An interventional study of T specific response for diagnostic of aspergillus bronchitis in Cystic Fibrosis Patient and Patient Without Treatment Against A.Fumigatus, sponsored by University Hospital, Montpellier. Terminated at 1 site in France. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2019-05-09.

Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Diagnostic

Why this study was terminated
Difficulties for inclusions
Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Not applicable
Ages
15 Years and older
Sex
All
01

Study summary

The study aims to asses the ability of cell tests based on the analysis of the anti-Aspergillus cell responses and identify Aspergillus bronchitis with patients with cystic fibrosis.

In addition, the study will evaluate the contribution of biological classification of aspergillosis according to criteria recently proposed by Baxter et al. compared to the classification used in clinical practice in the hospital of Montpellier.

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Conditions studied

  • Cystic Fibrosis Patient
  • Patient Without Treatment Against A.Fumigatus

Keywords

  • Bronchitis aspergillus
  • cystic fibrosis
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In context

Bronchitis

268 studies on the registry are indexed under Bronchitis; 26 are open to participants now.

This study's enrollment of 68 is below the median of 120 across 184 interventional studies indexed under Bronchitis.

Browse Bronchitis studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patient with cystic fibrosis followed at Resource Centers and Cystic Fibrosis Skills (CRCM) Montpellier
  • Patient aged 15 or over
  • Patient able to understand the nature, purpose and methodology of the study.
  • Patient and his legal representative for minors who have given their free and informed consent
  • Affiliate or beneficiary of a social security scheme.

Exclusion criteria

Exclusion Criteria:

  • Patients on antifungal treatment at the time of sampling
  • Pregnant or breastfeeding
  • Major protected by law (guardianship, curator or under Backup Justice)
  • Inability to understand the nature and goals of the study and / or communication difficulties with the investigator
  • Subject attending another search including a period of exclusion still going to run-in
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
68 participants (actual)

Study arms

  • Other
    Cystic fibrosis

    Other: T specific response for diagnostic of aspergillus bronchitis

Interventions

  • OtherT specific response for diagnostic of aspergillus bronchitis
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What researchers measure

Primary outcomes

  1. Number of CD4 T cell response against Aspergillus fumigatus in patients with cystis fibrosis

    Analysis T cells response for identification of aspergillus bronchitis with cystic fibrosis patients

    Time frame: 12 months

  2. Cytokine level of TCD8

    Qualitative Evaluation of cytokine level (IFNg, TNFa, IL10 and IL4) of TCD8 to identify ABPA and aspergillus bronchitis

    Time frame: 12 months

  3. Cytokine level CD4 cells

    Qualitative Evaluation of cytokine level CD4 cells in order to identify ABPA and aspergillus bronchitis

    Time frame: 12 months

Secondary outcomes

  1. Level of fumigatus specific IgE

    Contribution of several biological tests improve classification of aspergillus bronchitis

    Time frame: 12 months

  2. Level of fumigatus specific IgG

    Contribution of several biological tests improve classification of aspergillus bronchitis

    Time frame: 12 months

  3. Real-time PCR for aspergillus in sputum

    Contribution of several biological tests improve classification of aspergillus bronchitis

    Time frame: 12 months

  4. Galactomannan by enzyme immune assay detection in sputum

    Contribution of several biological tests improve classification of aspergillus bronchitis

    Time frame: 12 months

  5. Levels of cytokine (IFNg, IL10, IL4 and TNF) evaluated by flow cytometry

    Contribution of several biological tests improve classification of aspergillus bronchitis

    Time frame: 12 months

  6. Level of IL10 evaluated by Elispot dedicated to anti-aspergillus CD4 T cells

    Contribution of several biological tests improve classification of aspergillus bronchitis

    Time frame: 12 months

  7. Flow cytometry techniques dedicated to anti-aspergillus CD4 T cell assessment

    Time frame: 12 months

  8. Level of IFNg evaluated by Elispot dedicated to anti-aspergillus CD4 T cells

    Contribution of several biological tests improve classification of aspergillus bronchitis

    Time frame: 12 months

  9. Elispot dedicated to anti-aspergillus CD4 T cell

    Time frame: 12 months

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Study locations

1 site
  • Irmb/U1058
    Montpellier, 34000, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02550041
Lead sponsor
University Hospital, Montpellier
Responsible party
Sponsor
First posted
Sep 15, 2015
Start date
Sep 7, 2015
Primary completion
Sep 7, 2016
Completion
Jun 2017
Last update
May 9, 2019

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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