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A Study in Children and Adolescents With Birch Pollen-induced Rhinoconjunctivitis

NCT04878354 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 952

Last updated 2025-01-22

Study results available
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Summary

This is a clinical study in children and adolescents (5-17 years) with allergy to pollen from birch (or related trees). It compares the tree SLIT-tablet with placebo in relieving rhinoconjunctivitis symptoms during the birch/tree pollen season based on the average allergic rhinoconjunctivitis daily total combined score.

The study will also collect health-related quality of life information in the groups treated with the tree SLIT-tablet or with placebo during the pollen season.

The trial medication used is already approved to treat allergic rhinitis caused by birch/tree pollen in adults in several countries?.

Conditions

  • Allergy

Interventions

DRUG

Tree SLIT-tablet

Sublingual allergy immunotherapy tablets

DRUG

Placebo SLIT-tablet

Placebo

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • ALK-Abelló A/S

    lead INDUSTRY

Principal Investigators

  • Monika Gappa, Prof. MD · Evangelisches Krankenhaus Düsseldorf

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-07
Primary Completion
2023-07-31
Completion
2023-07-31

Countries

  • Austria
  • Belgium
  • Canada
  • Denmark
  • Germany
  • Hungary
  • Lithuania
  • Netherlands
  • Poland
  • Russia
  • Slovakia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04878354 on ClinicalTrials.gov