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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Stallergenes

ClinicalTrials.gov Identifier:

NCT01527188

First received: February 1, 2012

Last updated: February 3, 2012

Last verified: February 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	February 1, 2012
Last Updated Date	February 3, 2012
Start Date ^ICMJE	January 2011
Estimated Primary Completion Date	May 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 3, 2012)	Rhinitis total symptom score (RTSS) [ Time Frame: 6 months ] [ Designated as safety issue: No ] Rhinitis total symptom score = sneezing+rhinorrhea+nasal pruritus+ nasal congestion scored on 0-3 scale, total score range 0-12
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01527188 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 3, 2012)	Safety and tolerability [ Time Frame: 6 months and 18 months ] [ Designated as safety issue: No ] Analysis of adverse events Rhinitis total symptom score [ Time Frame: 18 months ] [ Designated as safety issue: No ] Rhinitis total symptom score=sneezing+rhinorrhea+nasal pruritus+nasal congestion scored on 0-3 scale, total score range 0-12
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Efficacy and Safety of 100IR, 300IR, 500IR Sublingual House Dust Mite (HDM) Tablets in Allergic Rhinitis Environment Exposure Chamber Model
Official Title ^ICMJE	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
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	House Dust Mites Allergic Rhinitis
Intervention ^ICMJE	Biological: 100IR 100IR sublingual tablet of Biological: 300IR 300IR sublingual tablets of Biological: 500IR 500IR sublingual tablet of Other: Placebo Placebo sublingual tablet of
Study Arm (s)	Experimental: 100IR Intervention: Biological: 100IR Experimental: 300IR Intervention: Biological: 300IR Experimental: 500IR Intervention: Biological: 500IR Placebo Comparator: Placebo Intervention: Other: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	355
Estimated Completion Date	November 2012
Estimated Primary Completion Date	May 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 55 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Canada

Administrative Information
NCT Number ^ICMJE	NCT01527188
Other Study ID Numbers ^ICMJE	VO67.10
Has Data Monitoring Committee	No
Responsible Party	Stallergenes
Study Sponsor ^ICMJE	Stallergenes
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Stallergenes
Verification Date	February 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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