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

Phase 2

Completed

• Conditions: Allergic Rhinitis Due to House Dust Mite
• Interventions: Biological: 500IR; Other: Placebo; Biological: 100IR; Biological: 300IR; Drug: 100 IR house dust mites allergen extract tablet; Drug: 300 IR house dust mites allergen extract tablet; Drug: 500 IR house dust mites allergen extract tablet; Drug: Placebo tablet

• Registration Number: NCT01527188
• Lead Sponsor: Stallergenes Greer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-08
• Study First Submitted: 2012-02-01
• Study First Submitted QC: 2012-02-03
• Study First Posted: 2012-02-06
• Primary Completion: 2012-03
• Study Completion: 2012-09-19
• Results First Submitted: 2024-11-27
• Status Verified: 2025-01
• Results First Submitted QC: 2025-01-31
• Last Update Submitted: 2025-01-31
• Results First Posted: 2025-02-04
• Last Update Posted: 2025-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 355

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
500IR	500IR	-
Placebo	Placebo	-
100IR	100IR	-
300IR	300IR	-
100 IR	100 IR house dust mites allergen extract tablet	100 IR house dust mites allergen extract tablet
300 IR	300 IR house dust mites allergen extract tablet	300 IR house dust mites allergen extract tablet
500 IR	500 IR house dust mites allergen extract tablet	500 IR house dust mites allergen extract tablet
Placebo	Placebo tablet	Placebo tablet

Primary Outcome Measures

Name	Time	Method
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	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 Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

Cetero Research; 🇨🇦 Mississauga, Ontario, Canada