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

Stallergenes Greer

Status and phase: Completed; Phase 2

Conditions: Allergic Rhinitis Due to House Dust Mite

Treatments: Drug: 100 IR house dust mites allergen extract tablet; Drug: Placebo tablet; Drug: 500 IR house dust mites allergen extract tablet; Drug: 300 IR house dust mites allergen extract tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT01527188

VO67.10

Details and patient eligibility

About

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.

Enrollment: 355 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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355 participants in 4 patient groups, including a placebo group

100 IR

Experimental group

Description:

100 IR house dust mites allergen extract tablet

Treatment:

Drug: 100 IR house dust mites allergen extract tablet

300 IR

Experimental group

Description:

300 IR house dust mites allergen extract tablet

Treatment:

Drug: 300 IR house dust mites allergen extract tablet

500 IR

Experimental group

Description:

500 IR house dust mites allergen extract tablet

Treatment:

Drug: 500 IR house dust mites allergen extract tablet

Placebo

Placebo Comparator group

Description:

Placebo tablet

Treatment:

Drug: Placebo tablet