Allergic Broncho-Pulmonary AspergillosisNCT01710930

Protocol TARC-ABPA

A study testing Study of predictive factors in people with Allergic Broncho-Pulmonary Aspergillosis, run by Nantes University Hospital at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Allergic Broncho-Pulmonary Aspergillosis
What is being tested?: Study of predictive factors
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 2 sitesFrance
Study dates: Jul 2012to 21 Sep 2017
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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,

Show all 10Show fewer

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.

Trial locations and contacts

2 sites in 1 country.

France2 sites

CHU Le Mans
Le Mans, 72037
Nantes University Hospital
Nantes, 44093

Other trials in France

About this study

Official title: 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 :

To investigate if induced sputum eosinophils count (compared to baseline) is associated with the occurrence of exacerbations.
To examine if the exhaled NO (compared to a baseline) is associated with the occurrence of exacerbations.
To investigate if activation of circulating T cells (compared to a baseline) is associated with the occurrence of exacerbations.
To examine if the rate of specific Asp f IgG measured by ELISA (compared to a baseline) is associated with the occurrence of exacerbations.
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).
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.
To establish if some of the clinical, functional or biological data studied are associated with the frequency of exacerbations.

Conditions: Allergic Broncho-Pulmonary Aspergillosis
Being tested: Study of predictive factors
Keywords: Allergic Broncho-Pulmonary Aspergillosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study of predictive factorsOther
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 groups in NCT01710930
Study group	Role	What they receive
Study of predictive factors	Experimental	Not described Receives: Other: Study of predictive factors

What is being measured

The primary outcome is the main question the study is designed to answer.

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
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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 201221 Sep 2017

First posted19 Oct 2012 (estimated)
Study startJul 2012
Primary completion21 Sep 2017
Study completion21 Sep 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Allergic Broncho-Pulmonary AspergillosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01710930
Sponsor's protocol ID: RC11_0158
Status last verified: Nov 2017
First submitted: 15 Oct 2012
Last updated: 6 Apr 2018
Results posted: No
Data monitoring committee: Yes

Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Interest of TARC Serum Marker for Follow-up of Patients With Allergic Broncho-Pulmonary Aspergillosis (ABPA), Excluding Cystic Fibrosis
ClinicalTrials.gov ID: NCT01710930
Acronym / sponsor ID: RC11_0158
Conditions: Allergic Broncho-Pulmonary Aspergillosis
Keywords: Allergic Broncho-Pulmonary Aspergillosis
Study type: Interventional
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: Nantes University HospitalUniversity, hospital or other
Study start: Jul 2012
Primary completion: 21 Sep 2017 (actual)
Study completion: 21 Sep 2017 (actual)
First posted: 19 Oct 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 :

To investigate if induced sputum eosinophils count (compared to baseline) is associated with the occurrence of exacerbations.
To examine if the exhaled NO (compared to a baseline) is associated with the occurrence of exacerbations.
To investigate if activation of circulating T cells (compared to a baseline) is associated with the occurrence of exacerbations.
To examine if the rate of specific Asp f IgG measured by ELISA (compared to a baseline) is associated with the occurrence of exacerbations.
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).
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.
To establish if some of the clinical, functional or biological data studied are associated with the frequency of exacerbations.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Study of predictive factors	Experimental	Other: Study of predictive factors

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (10 listed)

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,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Study of predictive factorsPhase 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).	Other	Study of predictive factors

Primary outcome

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).

9 secondary outcomes

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
Fungal exposure at home
Clincal parameters
Biological parameters
Function parameters

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anaïs PIPET, Doctor principal investigator

Nantes University Hospital

Hakima OUKSEL, Doctor study chair

University Hospital, Angers

François GOUPIL, Doctor study chair

CH du Mans

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Study of predictive factors in people with Allergic Broncho-Pulmonary Aspergillosis, run by Nantes University Hospital at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The rate of serum TARC. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01710930.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2018.