Evaluation of the Benefits of Sublingual AIT (PRACTIS)

NCT06574061 | Completed

• 1 other identifier: OTH-PES-08-FR
• Study Type: observational
• Target: 1,635
• Locations: 1 country
• Sites: 1

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).

Conditions

Allergic Rhinitis

Keywords

SLIT treatment, patient adherence/satisfaction, PBI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• PNQ (Patient Need Questionnaire)

  V1 (at study inclusion)

• PBI Patient Benefit Index

  Patient self-questionnaires returned at V1 (at study inclusion) and V2 (6, 9 or 12 months after treatment initiation)

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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 (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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stallergenes Greer: lead

Study Sites (1)

Stallergenes Greer

Antony, 92160, France

Location

MeSH Terms

Conditions

Rhinitis, Allergic; Patient Compliance; Personal Satisfaction

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Pascal DEMOLY, Professor

  CHU & IDESP, Montpellier, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 27, 2024
• Study Start: August 29, 2018
• Primary Completion: July 22, 2020
• Study Completion: October 14, 2021
• Last Updated: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)