Allergic RhinitisPRACTISNCT06574061
Evaluation of the Benefits of Sublingual AIT (PRACTIS)
An observational study of Allergic Rhinitis, run by Stallergenes Greer at 1 site in France.
Trial summary
The objective of the study was to evaluate in routine practice the benefits of sublingual allergen immunotherapy (SLIT) for allergic patients with allergic rhinitis (AR), with or without asthma, according to various methods of use (treatment regimen: formulation type, dose, duration, initiation) and type of allergen… Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Allergic Rhinitis
- How many people
- 1,635 participants
- Where
- 1 siteFrance
- Study dates
- 29 Aug 2018to 14 Oct 2021
- 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: The target population included adult patients, adolescents and children (aged ≥5 years) with an allergy to one or more allergens confirmed by a positive skin prick-test and/or the presence of specific IgE antibodies, and eligible for AIT.
Who may be able to join
- Patients aged 5 years or older
- Patients with a respiratory allergy with significant clinical symptoms and whose diagnosis was confirmed by a positive skin prick-test and/or the presence of specific IgE antibodies to one or more allergens implicated in the symptoms
- Patients eligible for AIT (patients who had been treated with AIT in the 3 years prior to the inclusion visit could be included if starting a new form and/or type of AIT)
- Patients previously treated with a pharmacological AR treatment in the month before the inclusion visit or during the previous pollen season, and requiring the initiation of AIT
- Patients (and/or their parents or legal representatives as appropriate) agreeing to take part in the study after having been informed orally and in writing by the observing physician.
Who cannot join
- Patient with a hypersensitivity (allergy) to any of the excipients in the selected AIT
- Patients taking beta-blockers (including local treatments, e.g. eye drops)
- If asthmatic patient:
- Patients with uncontrolled (unstable) or severe asthma (in adults this was defined as daily symptoms and FEV1 <70% of the theoretical value after appropriate drug treatment, and in children and adolescents by FEV1 <80% of the theoretical value after appropriate drug treatment)
- Patients who have had a severe asthma exacerbation in the last three months
- Asthmatic patient with unresolved acute infection of the airways.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation in Routine Practice of the Benefits of Sublingual Allergen Immunotherapy in Allergic Patients According to Different Modalities of Use
The objective of the study was to evaluate in routine practice the benefits of sublingual allergen immunotherapy (SLIT) for allergic patients with allergic rhinitis (AR), with or without asthma, according to various methods of use (treatment regimen: formulation type, dose, duration, initiation) and type of allergen (grass pollen, tree pollen, herbaceous pollen, house dust mites, animal dander, moulds and poly-reactive types).
Read the detailed description
The treatment considered was any SLIT (tablet or liquid forms) accepted by the patient and the parent(s) in the case of minor patients. The treatment was taken as prescribed by the observing physician.
The expected benefits for patients after approximately 6 and 12 months after initiation of SLIT included:
- Decreased intensity of symptoms
- Decreased discomfort
- Decreased consumption of symptomatic treatments or associated treatments (especially in asthmatic patients)
- Improved quality of life
- Reduced absenteeism from school or work
- Beneficial impact on leisure activities.
- Conditions
- Allergic Rhinitis
- Keywords
- SLIT treatment, patient adherence/satisfaction, PBI
- Medical subject headings
- Rhinitis, Allergic, Patient Compliance, Personal Satisfaction
What is being measured
The primary outcome is the main question the study is designed to answer.
PBQ (Patient Benefit Questionnaire)
The Patient Benefit Questionnaire (PBQ) was used as the primary endpoint to evaluate the benefits perceived by patients.
Measured: V1 / V2 (6, 9 or 12 months after treatment initiation)
Secondary outcomes (2)
PNQ (Patient Need Questionnaire)
The Patient Need Questionnaire (PNQ) was used to evaluate the expectations of patients regarding the prescription or new treatment(s) prescribed by the observing physicians.
Measured: V1 (at study inclusion)
PBI Patient Benefit Index
The overall PBI score was calculated using the PNQ questionnaire at V1 (treatment expectations) and the PBQ questionnaire at V2 (treatment benefits).
PBI is an index of the benefits perceived by patients with the AIT received. It considers patient expectations prior to AIT treatment and the perceived benefits after treatment.
A PBI ≥1 is considered as indicating a relevant benefit of the AIT treatment for the patient
Measured: Patient self-questionnaires returned at V1 (at study inclusion) and V2 (6, 9 or 12 months after treatment initiation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start29 Aug 2018
- Primary completion22 Jul 2020
- Study completion14 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,635 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stallergenes Greer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pascal DEMOLY, Professor, Principal investigator, CHU & IDESP, Montpellier, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06574061
- Sponsor's protocol ID
- OTH-PES-08-FR
- Acronym
- PRACTIS
- Status last verified
- Aug 2024
- First submitted
- 1 Aug 2024
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation in Routine Practice of the Benefits of Sublingual Allergen Immunotherapy in Allergic Patients According to Different Modalities of Use
- ClinicalTrials.gov ID
- NCT06574061
- Acronym / sponsor ID
- PRACTIS / OTH-PES-08-FR
- Conditions
- Allergic Rhinitis
- Keywords
- SLIT treatment, patient adherence/satisfaction, PBI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,635 participants (actual)
- Lead sponsor
- Stallergenes GreerIndustry (pharma, biotech, devices)
- Study start
- 29 Aug 2018 (actual)
- Primary completion
- 22 Jul 2020 (actual)
- Study completion
- 14 Oct 2021 (actual)
- First posted
- 27 Aug 2024 (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.
The objective of the study was to evaluate in routine practice the benefits of sublingual allergen immunotherapy (SLIT) for allergic patients with allergic rhinitis (AR), with or without asthma, according to various methods of use (treatment regimen: formulation type, dose, duration, initiation) and type of allergen (grass pollen, tree pollen, herbaceous pollen, house dust mites, animal dander, moulds and poly-reactive types).
Detailed description
The treatment considered was any SLIT (tablet or liquid forms) accepted by the patient and the parent(s) in the case of minor patients. The treatment was taken as prescribed by the observing physician.
The expected benefits for patients after approximately 6 and 12 months after initiation of SLIT included:
- Decreased intensity of symptoms
- Decreased discomfort
- Decreased consumption of symptomatic treatments or associated treatments (especially in asthmatic patients)
- Improved quality of life
- Reduced absenteeism from school or work
- Beneficial impact on leisure activities.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The target population included adult patients, adolescents and children (aged ≥5 years) with an allergy to one or more allergens confirmed by a positive skin prick-test and/or the presence of specific IgE antibodies, and eligible for AIT.
Key inclusion criteria (5 listed)
- Patients aged 5 years or older
- Patients with a respiratory allergy with significant clinical symptoms and whose diagnosis was confirmed by a positive skin prick-test and/or the presence of specific IgE antibodies to one or more allergens implicated in the symptoms
- Patients eligible for AIT (patients who had been treated with AIT in the 3 years prior to the inclusion visit could be included if starting a new form and/or type of AIT)
- Patients previously treated with a pharmacological AR treatment in the month before the inclusion visit or during the previous pollen season, and requiring the initiation of AIT
- Patients (and/or their parents or legal representatives as appropriate) agreeing to take part in the study after having been informed orally and in writing by the observing physician.
Key exclusion criteria (6 listed)
- Patient with a hypersensitivity (allergy) to any of the excipients in the selected AIT
- Patients taking beta-blockers (including local treatments, e.g. eye drops)
- If asthmatic patient:
- Patients with uncontrolled (unstable) or severe asthma (in adults this was defined as daily symptoms and FEV1 <70% of the theoretical value after appropriate drug treatment, and in children and adolescents by FEV1 <80% of the theoretical value after appropriate drug treatment)
- Patients who have had a severe asthma exacerbation in the last three months
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
PBQ (Patient Benefit Questionnaire)
Time frame: V1 / V2 (6, 9 or 12 months after treatment initiation)
The Patient Benefit Questionnaire (PBQ) was used as the primary endpoint to evaluate the benefits perceived by patients.
2 secondary outcomes
PNQ (Patient Need Questionnaire)
Time frame: V1 (at study inclusion)
PBI Patient Benefit Index
Time frame: Patient self-questionnaires returned at V1 (at study inclusion) and V2 (6, 9 or 12 months after treatment initiation)
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 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Allergic Rhinitis
Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
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RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
Active, not recruitingPhase 3
A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
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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, Professor principal investigator
CHU & IDESP, Montpellier, France
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 Allergic Rhinitis, run by Stallergenes Greer 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 5 inclusion and 6 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 Aug 2024. 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?
PBQ (Patient Benefit Questionnaire) (time frame: V1 / V2 (6, 9 or 12 months after treatment initiation)). 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 Aug 2024; AzTrials last refreshed its copy on 7 Nov 2026.