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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).
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:
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| Measure | Description | Time Frame |
|---|---|---|
| PBQ (Patient Benefit Questionnaire) | The Patient Benefit Questionnaire (PBQ) was used as the primary endpoint to evaluate the benefits perceived by patients. | V1 / V2 (6, 9 or 12 months after treatment initiation) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | V1 (at study inclusion) |
| PBI Patient Benefit Index |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Pascal DEMOLY, Professor | CHU & IDESP, Montpellier, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stallergenes Greer | Antony | 92160 | France |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D010349 | Patient Compliance |
| D010549 | Personal Satisfaction |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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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 |
| Patient self-questionnaires returned at V1 (at study inclusion) and V2 (6, 9 or 12 months after treatment initiation) |
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |