NCT01199133

Brief Summary

The purpose of this study is to assess the efficacy of one dose of sublingual immunotherapy (SLIT) administered to children and adolescents as allergen-based tablets once daily over a period of 24 months over 3 years compared to placebo, for reduction of allergic rhinitis symptoms and rescue medication use.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
471

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2009

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 10, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
13.5 years until next milestone

Results Posted

Study results publicly available

February 11, 2025

Completed
Last Updated

February 11, 2025

Status Verified

January 1, 2025

Enrollment Period

1.3 years

First QC Date

September 9, 2010

Results QC Date

November 27, 2024

Last Update Submit

January 23, 2025

Conditions

Allergic Rhinitis Due to Dust Mite

Outcome Measures

Primary Outcomes (1)

  • Average Adjusted Symptom Score (AASS) During the Treatment Period

    The primary efficacy endpoint was the Average Adjusted Symptom Score (AAdSS) during the period from 1 October 2010 to 30 November 2010 (Year 1 Primary Period) assessed in the Full Analysis Set defined for Year 1. The Average Adjusted Symptom Score (AAdSS) ranges from 0 to 12, with a higher score meaning a worse outcome. It is a score assessing four rhinitis symptoms: sneezing, rhinorrhoea, nasal pruritus and nasal congestion, adjusted on the rescue medication intake

    Year 1 Primary Period = 01 OCT to 30 NOV 2010 The value was obtained by averaging the daily scores over the primary period

Study Arms (2)

300 IR

ACTIVE COMPARATOR

300 IR house dust mites allergen extract tablet

Drug: 300 IR house dust mites allergen extract tablet

Placebo

PLACEBO COMPARATOR

Placebo tablet

Drug: Placebo tablet

Interventions

300 IR house dust mites allergen extract tabletDRUG

One sublingual tablet daily for one year.

Also known as: House dust mites (Der p and Der f) allergen extract tablet
300 IR
Placebo tabletDRUG

One sublingual tablet daily for one year.

Also known as: Sublingual placebo tablet
Placebo

Eligibility Criteria

Age5 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Male or female outpatients, aged 5-17 years inclusive
  • History of house dust mite-related allergic rhinitis for at least 1 year requiring regular intake of symptomatic treatment(s)
  • Sensitised to D. pteronyssinus and/or D. farinae (positive skin prick test with wheal diameter greater than 3 mm and specific IgE level ≥ 0.7 kU/L)

You may not qualify if:

  • Co-sensitization associated with clinically relevant allergic rhinitis, sinusitis, conjunctivitis or asthma likely to significantly change the symptoms of the patient throughout the study (that means patient symptomatic to another allergen than house dust mites to which the patient will be exposed during the study, i.e. will notably be excluded
  • patients sensitised to cat or dog allergens and regularly exposed to these allergens
  • patients sensitised to aspergillus, cladosporium, alternaria
  • patients sensitised to parietaria , ragweed, or mugwort, if this allergen is endemic to the region

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Worm M, Demoly P, Okamoto Y, Vidal C, Daghildjian K, Yan K, Casale TB, Bergmann KC. Safety of 300IR house dust mite sublingual tablet from pooled clinical trial and post-marketing data. World Allergy Organ J. 2024 Jun 25;17(7):100924. doi: 10.1016/j.waojou.2024.100924. eCollection 2024 Jul.

    PMID: 39035788DERIVED

MeSH Terms

Interventions

Allergens

Intervention Hierarchy (Ancestors)

AntigensBiological Factors

Results Point of Contact

Title
Michel Roux, Medical Director
Organization
Stallergenes
mroux@stallergenes.com
+33 (0) 1 55 59 29 70

Study Officials

  • Ulrich Wahn, MD

    Charite- Campus Virchow klinikum

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2010

First Posted

September 10, 2010

Study Start

October 1, 2009

Primary Completion

January 1, 2011

Study Completion

September 1, 2011

Last Updated

February 11, 2025

Results First Posted

February 11, 2025

Record last verified: 2025-01