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

• Sponsor: Stallergenes Greer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01527188
• Collaborator: (none)
• Enrollment: 355
• Location: 1
• Arms: 4
• Duration (Months): 20
• Patients Per Site Per Month: 17.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
House Dust Mites Allergic Rhinitis	Biological: 100IR; Biological: 300IR; Biological: 500IR; Other: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 355 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 100IR	Biological: 100IR; 100IR sublingual tablet of
Experimental: 300IR	Biological: 300IR; 300IR sublingual tablets of
Experimental: 500IR	Biological: 500IR; 500IR sublingual tablet of
Placebo Comparator: Placebo	Other: Placebo; Placebo sublingual tablet of

Outcome Measures

Primary Outcome Measures

1. Rhinitis total symptom score (RTSS) [6 months]

   Rhinitis total symptom score = sneezing+rhinorrhea+nasal pruritus+ nasal congestion scored on 0-3 scale, total score range 0-12

Secondary Outcome Measures

1. Safety and tolerability [6 months and 18 months]

   Analysis of adverse events

2. Rhinitis total symptom score [18 months]

   Rhinitis total symptom score=sneezing+rhinorrhea+nasal pruritus+nasal congestion scored on 0-3 scale, total score range 0-12

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cetero Research	Mississauga	Ontario	Canada	L4W 1N2

Sponsors and Collaborators

• Stallergenes Greer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stallergenes Greer
• ClinicalTrials.gov Identifier: NCT01527188
• Other Study ID Numbers: VO67.10
• First Posted: Feb 6, 2012
• Last Update Posted: Aug 2, 2013
• Last Verified: Aug 1, 2013

• Keywords provided by Stallergenes Greer: HDM; allergic rhinitis
• Additional relevant MeSH terms: Rhinitis; Rhinitis, Allergic

Study Results

No Results Posted as of Aug 2, 2013