Allergen ImmunotherapyCHOICENCT04038268
Criteria Used by Health Professionals on the Selection of Allergen Immunotherapy in Real Clinical Practice
An observational study of Allergen Immunotherapy, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Background : Allergen Immunotherapy (AIT) is the only etiological treatment for allergic respiratory diseases. In order to improve the competence on the use of AIT, it is important to extend the investigator's knowledge on its use in routine clinical practice, outside the experimental setting of clinical trials, in… Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Allergen Immunotherapy
- Type of treatment
- Pill or oral medicine
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2019to 30 Sep 2020
- Phase
- Observational
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with IgE mediated hypersensitivity to aeroallergens who will initiate AIT, either SCIT, SLIT-drops or SLIT-tablets according to real life clinical standards of practice
Who may be able to join
- Patients with IgE mediated respiratory allergy
- Patients who will initiate any type of aeroallergen AIT according to real life clinical standards of practice
- Any type of aeroallergen for AIT will be included : pollen, house dust mite, animal, dander, moulds
- Patient who is under the care of the Doctor participating in the survey
Who cannot join
- Patients who refuse to give their informed consent
- Food immunotherapy
- Venom Immunotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Criteria Used by Health Professionals on the Selection of Allergen Immunotherapy in Real Clinical Practice: an International E-survey
Background : Allergen Immunotherapy (AIT) is the only etiological treatment for allergic respiratory diseases. In order to improve the competence on the use of AIT, it is important to extend the investigator's knowledge on its use in routine clinical practice, outside the experimental setting of clinical trials, in real life population of patients receiving AIT.
Objective: To evaluate the clinical criteria used by treating clinicians and by the patients themselves, when establishing AIT as treatment in a patient with respiratory disease caused by an IgE-dependent-hypersensitivity to aeroallergens Methods: In 6 country (Denmark, France, Germany, Norway, Spain \& Sweden), the national coordinator will be directly responsible for selection of Survey Doctor's participants (Investigators).
Read more
During 12 months:
- Firstly, each investigator will complete the Survey Doctor, online, on SurveyMonkey platform to explain what are the key drivers in Allergen Immunotherapy (AIT) selection (Doctors' Questionnaire, DQ).
- On the other hand, at each AIT prescription to a patient, doctors will complete the Survey Patient, on the same platform, to explain how and why they have chosen this type of AIT (Patients' Questionnaire, PQ).
- Conditions
- Allergen Immunotherapy
- Keywords
- Immunotherapy, Real Clinical Practice, Respiratory disease, Aeroallergens, IgE-dependent hypersensitivity
- Medical subject headings
- Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Adults and children, males and females, with IgE mediated pollen, house dust mites, animal dander and moulds respiratory allergy who will initiate aeroallergen AIT, either SCIT, SLIT-drops or SLIT-tablets according to real life clinical standards of practice | |
| Prescribers | Doctors who are currently prescribing AIT as part of their regular clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical criteria in AIT
Clinical criteria used by treating clinicians and by the patients themselves, when establishing AIT as treatment in a patient with respiratory disease. These are called "drivers of prescription".
caused by an IgE-dependent-hypersensitivity to aeroallergens Among the different criteria selected by participants, order of priority of AIT drivers will be established
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start1 Sep 2019
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergen ImmunotherapyStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal Demoly, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04038268
- Sponsor's protocol ID
- RECHMPL19_0361
- Acronym
- CHOICE
- Status last verified
- Dec 2020
- First submitted
- 12 Jul 2019
- Last updated
- 29 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Criteria Used by Health Professionals on the Selection of Allergen Immunotherapy in Real Clinical Practice: an International E-survey
- ClinicalTrials.gov ID
- NCT04038268
- Acronym / sponsor ID
- CHOICE / RECHMPL19_0361
- Conditions
- Allergen Immunotherapy
- Keywords
- Immunotherapy, Real Clinical Practice, Respiratory disease, Aeroallergens, IgE-dependent hypersensitivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 30 Jul 2019 (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.
Background : Allergen Immunotherapy (AIT) is the only etiological treatment for allergic respiratory diseases. In order to improve the competence on the use of AIT, it is important to extend the investigator's knowledge on its use in routine clinical practice, outside the experimental setting of clinical trials, in real life population of patients receiving AIT.
Objective: To evaluate the clinical criteria used by treating clinicians and by the patients themselves, when establishing AIT as treatment in a patient with respiratory disease caused by an IgE-dependent-hypersensitivity to aeroallergens Methods: In 6 country (Denmark, France, Germany, Norway, Spain \& Sweden), the national coordinator will be directly responsible for selection of Survey Doctor's participants (Investigators).
During 12 months:
- Firstly, each investigator will complete the Survey Doctor, online, on SurveyMonkey platform to explain what are the key drivers in Allergen Immunotherapy (AIT) selection (Doctors' Questionnaire, DQ).
- On the other hand, at each AIT prescription to a patient, doctors will complete the Survey Patient, on the same platform, to explain how and why they have chosen this type of AIT (Patients' Questionnaire, PQ).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Adults and children, males and females, with IgE mediated pollen, house dust mites, animal dander and moulds respiratory allergy who will initiate aeroallergen AIT, either SCIT, SLIT-drops or SLIT-tablets according to real life clinical standards of practice |
| Prescribers | – | –Doctors who are currently prescribing AIT as part of their regular clinical practice |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with IgE mediated hypersensitivity to aeroallergens who will initiate AIT, either SCIT, SLIT-drops or SLIT-tablets according to real life clinical standards of practice
Key inclusion criteria (4 listed)
- Patients with IgE mediated respiratory allergy
- Patients who will initiate any type of aeroallergen AIT according to real life clinical standards of practice
- Any type of aeroallergen for AIT will be included : pollen, house dust mite, animal, dander, moulds
- Patient who is under the care of the Doctor participating in the survey
Key exclusion criteria (3 listed)
- Patients who refuse to give their informed consent
- Food immunotherapy
- Venom Immunotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical criteria in AIT
Time frame: 1 day
Clinical criteria used by treating clinicians and by the patients themselves, when establishing AIT as treatment in a patient with respiratory disease. These are called "drivers of prescription". caused by an IgE-dependent-hypersensitivity to aeroallergens Among the different criteria selected by participants, order of priority of AIT drivers will be established
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 29 Dec 2020.
- Individual participant dataSharing planned: Undecided. NC
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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.
Pascal Demoly principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergen Immunotherapy, run by University Hospital, Montpellier 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 4 inclusion and 3 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 29 Dec 2020. 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?
Clinical criteria in AIT (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Dec 2020.