Evaluation of the Benefits of Sublingual AIT (PRACTIS) (PRACTIS)

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).

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis

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 Type: Observational
• Enrollment (Actual): 1635

Contacts and Locations

Study Locations

• France
  • Antony, France, 92160
    • Stallergenes Greer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Stallergenes Greer
• Investigators: Principal Investigator: Pascal DEMOLY, Professor, CHU & IDESP, Montpellier, France

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2018
• Primary Completion (Actual): July 22, 2020
• Study Completion (Actual): October 14, 2021

Study Registration Dates

• First Submitted: August 1, 2024
• First Submitted That Met QC Criteria: August 23, 2024
• First Posted (Actual): August 27, 2024

Study Record Updates

• Last Update Posted (Actual): August 29, 2024
• Last Update Submitted That Met QC Criteria: August 27, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: SLIT treatment, patient adherence/satisfaction, PBI
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: OTH-PES-08-FR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No