Skip to main content
OpenTrials
Completed

NCT Number: NCT06574061

Evaluation of the Benefits of Sublingual AIT (PRACTIS)

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

5 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stallergenes Greer

Antony, 92160, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. PBQ (Patient Benefit Questionnaire)

    Time frame: V1 / V2 (6, 9 or 12 months after treatment initiation)

    The Patient Benefit Questionnaire (PBQ) was used as the primary endpoint to evaluate the benefits perceived by patients.

Secondary outcomes

  1. PNQ (Patient Need Questionnaire)

    Time frame: V1 (at study inclusion)

    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.

  2. PBI Patient Benefit Index

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

    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

Sponsors and collaborators

Lead sponsor

Stallergenes Greer

Industry

Registry information

Official study title

Evaluation in Routine Practice of the Benefits of Sublingual Allergen Immunotherapy in Allergic Patients According to Different Modalities of Use

Acronym: PRACTIS

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Aug 27, 2024
Registry last updated
Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.