Safety Study of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts in Adolescents

January 3, 2014 updated by: Stallergenes Greer

Investigation of the Safety and Tolerability of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts in Adolescents With House Dust Mite-associated Allergic Rhinitis

The purpose of this study is to investigate the safety and tolerability of different doses of sublingual tablets of house dust mite (HDM) allergen extracts in adolescents with house dust mite-associated allergic rhinitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Mississauga, Ontario, Canada, L4W 1N2
        • Inflamax Research Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Written informed consent from patient and parent(s)/legal representative.
  • Male or female patient from 12 to 17 years.
  • Diagnosed rhinitis with medical history consistent with HDM-induced allergic rhinitis for at least 1 year before visit 1
  • Positive Skin Prick Test to House Dust Mites(HDM)and HDM-specific IgE serum value ≥ 0.7 kUnit/L.
  • Concommittant controlled asthma allowed up to GINA 1 or 2 treatment step
  • Spirometry with best FEV1 > 80% of predicted FEV1.

Exclusion Criteria:

  • Patient with a nasal or oral disease that could interfere with the safety assessments
  • Patient has undergone recent nasal surgery
  • Patient with asthma receiving therapy consistent with GINA (Global INitiative for Asthama) treatment step 3, 4, or 5.
  • Patient with partially controlled or uncontrolled asthma
  • Patient with a past or current disease, which as judged by the Investigator, may affect the patient's participation in or the outcome of this study.
  • Female patient pregnant or breast-feeding/lactating.
  • Female patient of childbearing potential planning a pregnancy during this trial or not using a medically accepted contraceptive method.
  • Patient treated with beta-blockers, tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs).
  • Patient who received allergy specific immunotherapy for house dust mites for more than 1 month in the 5 years before screening or who is currently receiving immunotherapy with any allergen.
  • patient with a history of anaphylaxis
  • patient having participated in any clinical study within the 12 weeks before visit 1

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo Sub Lingual Immunotherapy Tablets (SLIT)
Placebo tablets Matching the HDM allergen extract Sub Lingual Immunotherapy Tablets
Biological: SLIT tablets of HDM allergen extracts
EXPERIMENTAL: SLIT of HDM allergen extracts
Sublingual Immunotherapy Tablets of House Dust Mite allergen extracts
Biological: SLIT tablets of HDM allergen extracts

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability evaluated on treatment emergent adverse events
Time Frame: 10 dosing treatment days
Safety, tolerability evaluated on treatment adverse events and safety laboratory testings
10 dosing treatment days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment emergent Serious Adverse Events
Time Frame: 10 dosing treatment days
Treatment emergent Serious Adverse Events
10 dosing treatment days
Adverse Events leading to study withdrawal
Time Frame: 10 dosing treatment days
Incidence of adverse events leading to study withdrawal
10 dosing treatment days
Spirometry parameters
Time Frame: 10 dosing treatment days
Change in spirometry parameters between selection visit and last treatment day
10 dosing treatment days
Safety laboratory testings
Time Frame: 10 dosing treatment days
Change in safety laboratory testing values between selection visit and last treatment day
10 dosing treatment days
12 lead ECG parameters
Time Frame: 10 dosing treatment days
Change in ECG parameters between selection visit and last treatment day
10 dosing treatment days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stallergenes Greer

Collaborators

Syneos Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (ACTUAL)

September 1, 2013

Study Completion (ACTUAL)

September 1, 2013

Study Registration Dates

First Submitted

August 2, 2013

First Submitted That Met QC Criteria

August 6, 2013

First Posted (ESTIMATE)

August 9, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 6, 2014

Last Update Submitted That Met QC Criteria

January 3, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VO73.13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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