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

House Dust Mites Allergic Rhinitis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01527188
• Other study ID #: VO67.10
• Status: Completed
• Phase: Phase 2
• First received: February 1, 2012
• Last updated: August 1, 2013
• Start date: January 2011
• Est. completion date: September 2012

Study information

• Verified date: August 2013
• Source: Stallergenes
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 355
• Est. completion date: September 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• House Dust Mites Allergic Rhinitis
• Rhinitis

Intervention

Biological:
• 100IR
100IR sublingual tablet of
• 300IR
300IR sublingual tablets of
• 500IR
500IR sublingual tablet of

Other:
• Placebo
Placebo sublingual tablet of

Locations

Country	Name	City	State
Canada	Cetero Research	Mississauga	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Stallergenes

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rhinitis total symptom score (RTSS)	Rhinitis total symptom score = sneezing+rhinorrhea+nasal pruritus+ nasal congestion scored on 0-3 scale, total score range 0-12	6 months	No
Secondary	Safety and tolerability	Analysis of adverse events	6 months and 18 months	No
Secondary	Rhinitis total symptom score	Rhinitis total symptom score=sneezing+rhinorrhea+nasal pruritus+nasal congestion scored on 0-3 scale, total score range 0-12	18 months	No