Avian Hypersensitivity PneumonitisHYPERSENSNCT03056404
Research for Specific Proteins of Interest for the Serological Diagnosis of Bird Fancier's Lung
A study testing additional blood sample and respiratory functional exploration in people with Avian Hypersensitivity Pneumonitis, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
This study aims at identifying bird proteins useful for diagnostic tests to determine the cause of Bird Fancier's Lung (BFL). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Avian Hypersensitivity Pneumonitis
- What is being tested?
- additional blood sample and respiratory functional exploration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jun 2016to 28 Sep 2016
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Exposure known about birds
- Non-smoker
- Absence of compatible respiratory symptoms with a HP
Who cannot join
- Farmer,
- smoker,
- pregnancy and feeding,
- minor subject,
- known immunizing deficit
Trial locations and contacts
1 site in 1 country.
About this study
This study aims at identifying bird proteins useful for diagnostic tests to determine the cause of Bird Fancier's Lung (BFL).
Read the detailed description
Allergic diseases are an important part of health concerns in Europe and in countries "industrialized". Among them are distinguished from hypersensitivity pneumonitis (HP), consecutive to repeated inhalation of organic substances (bacteria, fungi, avian proteins ...).
As with other HP, the BFL is a invalidating disease, but usually not lethal if the patient reduced sufficiently early exposure to antigens.
Associated symptoms include breathing difficulties a dry cough, a general fatigued state accompanied by a fever and a rapid and pronounced weight loss.
These clinical signs may be similar to a flu-like condition, difficult to discern from other respiratory disease. Diagnosis is based on a set of clinical, radiological and biological arguments that are often discussed.
Using these criteria as predictors would increase opportunities to diagnose HP without using invasive clinical examinations such as biopsy and bronchoalveolar lavage.
Although serology is a useful argument for the diagnosis, its value is often criticized.
Thus, significant variations in performance of serological tests are observed from one provider to another and, for the same supplier, from one batch to another.
This issue could be raised by the use of recombinant antigens. The principle is to use only to the reaction the purified protein of interest produced by genetic engineering.
The Parasitology-Mycology department has acquired expertise in the research of proteins of interest for serology allergic diseases and in the manufacture of recombinant antigens. Thus the work of the team have identified proteins of interest for the diagnosis of two HP of occupational origin and translates this expertise to identify pigeon's proteins and study the feasibility of this research.
For this project, the pigeon droppings (Columba livia), collected from different breeders in the region were identified as antigenic source.
The objective of the HYPERSENS project is to extend the problematic to other species of birds and understand the specific species of antigenic proteins. The aim is also to identify and produce recombinant proteins that will identify the cause of avian hypersensitivity pneumonitis.
- Conditions
- Avian Hypersensitivity Pneumonitis
- Being tested
- additional blood sample, respiratory functional exploration
- Medical subject headings
- Bird Fancier's Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
additional blood sampleOther
respiratory functional explorationOther
| Study group | Role | What they receive |
|---|---|---|
| control subject | Experimental | additional blood sample and 15 control subjects will be seen in consultations in the service of pneumology. The visit will include an auscultation, a respiratory functional exploration and a blood test (2 tubes of 7 ml of total blood). A questionnaire of exhibition will be realized to collect the species of birds and the times of exhibition. Receives: Other: additional blood sample; Other: respiratory functional exploration |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of protein of interest
5 and 15 proteins for all selected birds
Measured: 24 months
Secondary outcomes (2)
Selection and identification of protein of interest specific for each selected bird
Identifying at least three specific proteins for each bird species by 2D-Electrophoresis and Western blotting (based on previous study).
Measured: 24 months
Selection and identification of proteins of interest common to all selected bird'droppings
Identifying at least one common protein to all droppings of selected bird species by 2D-Electrophoresis and Western blotting. This protein will be recognized by the antibodies of all patients regardless of their exposure and not recognized by controls. It would make the diagnosis of BFL for any avian exposure.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2017
- Study start20 Jun 2016
- Primary completion28 Sep 2016
- Study completion28 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Avian Hypersensitivity PneumonitisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurence Millon, Principal investigator, lmillon@chu-besancon.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03056404
- Sponsor's protocol ID
- API/2015/66
- Acronym
- HYPERSENS
- Status last verified
- Nov 2019
- First submitted
- 10 Aug 2016
- Last updated
- 21 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Rouzet A, Reboux G, Dalphin JC, Gondouin A, De Vuyst P, Balliau T, Millon L, Valot B, Roussel S. An immunoproteomic approach revealed antigenic proteins enhancing serodiagnosis performance of bird fancier's lung. J Immunol Methods. 2017 Nov;450:58-65. doi: 10.1016/j.jim.2017.07.012. Epub 2017 Jul 29.
PubMed 28760669
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research for Specific Proteins of Interest for the Serological Diagnosis of Bird Fancier's Lung
- ClinicalTrials.gov ID
- NCT03056404
- Acronym / sponsor ID
- HYPERSENS / API/2015/66
- Conditions
- Avian Hypersensitivity Pneumonitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 20 Jun 2016 (actual)
- Primary completion
- 28 Sep 2016 (actual)
- Study completion
- 28 Sep 2016 (actual)
- First posted
- 17 Feb 2017 (actual)
- 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.
This study aims at identifying bird proteins useful for diagnostic tests to determine the cause of Bird Fancier's Lung (BFL).
Detailed description
Allergic diseases are an important part of health concerns in Europe and in countries "industrialized". Among them are distinguished from hypersensitivity pneumonitis (HP), consecutive to repeated inhalation of organic substances (bacteria, fungi, avian proteins ...).
As with other HP, the BFL is a invalidating disease, but usually not lethal if the patient reduced sufficiently early exposure to antigens.
Associated symptoms include breathing difficulties a dry cough, a general fatigued state accompanied by a fever and a rapid and pronounced weight loss.
These clinical signs may be similar to a flu-like condition, difficult to discern from other respiratory disease. Diagnosis is based on a set of clinical, radiological and biological arguments that are often discussed.
Using these criteria as predictors would increase opportunities to diagnose HP without using invasive clinical examinations such as biopsy and bronchoalveolar lavage.
Although serology is a useful argument for the diagnosis, its value is often criticized.
Thus, significant variations in performance of serological tests are observed from one provider to another and, for the same supplier, from one batch to another.
This issue could be raised by the use of recombinant antigens. The principle is to use only to the reaction the purified protein of interest produced by genetic engineering.
The Parasitology-Mycology department has acquired expertise in the research of proteins of interest for serology allergic diseases and in the manufacture of recombinant antigens. Thus the work of the team have identified proteins of interest for the diagnosis of two HP of occupational origin and translates this expertise to identify pigeon's proteins and study the feasibility of this research.
For this project, the pigeon droppings (Columba livia), collected from different breeders in the region were identified as antigenic source.
The objective of the HYPERSENS project is to extend the problematic to other species of birds and understand the specific species of antigenic proteins. The aim is also to identify and produce recombinant proteins that will identify the cause of avian hypersensitivity pneumonitis.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| control subject | Experimental | Other: additional blood sample, Other: respiratory functional explorationadditional blood sample and 15 control subjects will be seen in consultations in the service of pneumology. The visit will include an auscultation, a respiratory functional exploration and a blood test (2 tubes of 7 ml of total blood). A questionnaire of exhibition will be realized to collect the species of birds and the times of exhibition. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Exposure known about birds
- Non-smoker
- Absence of compatible respiratory symptoms with a HP
Key exclusion criteria (5 listed)
- Farmer,
- smoker,
- pregnancy and feeding,
- minor subject,
- known immunizing deficit
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 |
|---|---|---|
| additional blood sample | Other | control subject |
| respiratory functional exploration | Other | control subject |
Primary outcome
number of protein of interest
Time frame: 24 months
5 and 15 proteins for all selected birds
2 secondary outcomes
Selection and identification of protein of interest specific for each selected bird
Time frame: 24 months
Selection and identification of proteins of interest common to all selected bird'droppings
Time frame: 24 months
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 21 Nov 2019.
- Derived from this study: PubMed 28760669Rouzet A, Reboux G, Dalphin JC, Gondouin A, De Vuyst P, Balliau T, Millon L, Valot B, Roussel S. An immunoproteomic approach revealed antigenic proteins enhancing serodiagnosis performance of bird fancier's lung. J Immunol Methods. 2017 Nov;450:58-65. doi: 10.1016/j.jim.2017.07.012. Epub 2017 Jul 29.
- Individual participant dataSharing planned: No
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.
Laurence Millon principal investigator
lmillon@chu-besancon.fr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing additional blood sample and respiratory functional exploration in people with Avian Hypersensitivity Pneumonitis, run by Centre Hospitalier Universitaire de Besancon at 1 site 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 3 inclusion and 5 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 21 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
number of protein of interest (time frame: 24 months). 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 NCT03056404, which also lists 1 linked publication.
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 21 Nov 2019.