Clinical trial NCT06574061: Evaluation of the Benefits of Sublingual AIT (PRACTIS)
Official title: Evaluation in Routine Practice of the Benefits of Sublingual Allergen Immunotherapy in Allergic Patients According to Different Modalities of Use
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergic Rhinitis
Keywords: SLIT treatment, patient adherence/satisfaction, PBI
Lead sponsor: Stallergenes Greer
Sponsor class: INDUSTRY
First posted: 2024-08-27
Enrollment: 1635
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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 (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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: PBQ (Patient Benefit Questionnaire)
timeFrame: V1 / V2 (6, 9 or 12 months after treatment initiation)
Secondary outcomes:
measure: PNQ (Patient Need Questionnaire)
timeFrame: V1 (at study inclusion)
measure: PBI Patient Benefit Index
timeFrame: Patient self-questionnaires returned at V1 (at study inclusion) and V2 (6, 9 or 12 months after treatment initiation)
Other outcomes:
Locations:
city: Antony
country: France
facility: Stallergenes Greer
Study officials:
affiliation: CHU & IDESP, Montpellier, France
name: Pascal DEMOLY, Professor
role: PRINCIPAL_INVESTIGATOR
References: