Status:
COMPLETED
Evaluation of the Benefits of Sublingual AIT (PRACTIS)
Lead Sponsor:
Stallergenes Greer
Conditions:
Allergic Rhinitis
Eligibility:
All Genders
5+ years
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, accor...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 29 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 14 2021
Estimated Enrollment :
1635 Patients enrolled
Trial Details
Trial ID
NCT06574061
Start Date
August 29 2018
End Date
October 14 2021
Last Update
August 29 2024
Active Locations (1)
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1
Stallergenes Greer
Antony, France, 92160