Skip to main content
OpenTrials
Completed

NCT Number: NCT01527188

Efficacy and Safety of 100IR, 300IR, 500IR Sublingual House Dust Mite Tablets in Allergic Rhinitis Environment Exposure Chamber Model

The purpose of this study is to assess the effect of 3 doses of sublingual house dust mite (HDM) tablets versus placebo in the change from baseline of rhinitis total symptom score during the allergen chamber challenge before and after 6 months of treatment.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Allergic Rhinitis Due to House Dust Mite Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cetero Research

Mississauga, Ontario, L4W 1N2, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • history of HDM rhinitis allergy for > 1 year
  • sensitized to D. pteronyssinus and/or D. farinae
  • RTSS >= 6 at least 2 time points during allergen challenge session

Exclusion criteria

  • co sensitization to other allergen than HDM
  • FEV1 < 80%
  • Asthma GINA > 1

Treatment and study plan

100 IR house dust mites allergen extract tablet

Drug

One sublingual tablet daily during 6 months

Other names: Sublingual immunotherapy tablet

300 IR house dust mites allergen extract tablet

Drug

One sublingual tablet daily during 6 months

Other names: Sublingual immunotherapy tablet

500 IR house dust mites allergen extract tablet

Drug

One sublingual tablet daily during 6 months

Other names: Sublingual immunotherapy tablet

Placebo Tablet

Drug

One sublingual tablet daily during 6 months

Other names: Sublingual placebo tablet

Primary outcomes

  1. Change From Baseline to the End-of-treatment Period in the Area Under the Curve of the Rhinitis Total Symptom Score Recorded During 4 Hours (0-4h) of the Allergen Challenge

    Time frame: 6 months

    The primary efficacy endpoint was the change from baseline (ChBL) (that is the first allergen challenge before treatment initiation) to the end-of-treatment period (6 months) in the Area Under the Curve (AUC) of the Rhinitis Total Symptom Score (RTSS) recorded during the four hours of the allergen challenge in the Environmental Exposure Chamber (EEC).

    The RTSS is the sum of four individual nasal symptom scores (rhinorrhoea, nasal congestion, nasal pruritus and sneezing), each assessed on a 0-3 rating scale. The RTSS was evaluated every 15 minutes in the first 2 hours and every 30 minutes in the last two hours, i.e. at 13 timepoints during each allergen challenge (from T0 to T240), and the scores were plotted against time (0 to 4 hours) to calculate the area under the curve, AUCRTSS_0-4h. A decrease in the AUCRTSS_0-4h value represents relief from the HDM allergic symptoms.

Secondary outcomes

  1. Change From Baseline to the End-of-treatment Period in the Area Under the Curve of the Rhinitis Total Symptom Score Recorded During 2 Hours (2-4h) of the Allergen Challenge

    Time frame: 6 months

    Change from baseline (ChBL) (that is the first allergen challenge before treatment initiation) to the end-of-treatment period (6 months) in the Area Under the Curve (AUC) of the Rhinitis Total Symptom Score (RTSS) recorded during the last two hours (2-4h) of the allergen challenge in the Environmental Exposure Chamber (EEC).

    The RTSS is the sum of four individual nasal symptom scores (rhinorrhoea, nasal congestion, nasal pruritus and sneezing), each assessed on a 0-3 rating scale.

Sponsors and collaborators

Lead sponsor

Stallergenes Greer

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Dose Ranging Phase II Study to Assess the Efficacy and Safety of 100IR, 300IR and 500IR Sublingual Tablets of House Dust Mite Allergen for the Treatment of Allergic Rhinitis in an Environmental Exposure Chamber Model

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Feb 6, 2012
Registry last updated
Feb 4, 2025

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.