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

June 30, 2014 updated by: Stallergenes Greer

Investigation of the Safety, Tolerability and Pharmacodynamic Effects of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts in Adults With House Dust Mite-associated Allergic Asthma

The purpose of this study is to investigate the safety of different doses of sublingual tablets of house dust mite allergen extracts in adults with house dust mite-associated allergic asthma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

94

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

  • France
      • Montpellier, France, 34295
        • CHU Arnaud de Villeneuve

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

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Written informed consent.
  • Male or female patient from 18 to 50 years.
  • Diagnosed asthma with medical history consistent with HDM-induced allergic asthma.
  • Positive SPT to House Dust Mites(HDM)and HDM-specific IgE serum value ≥ 0.7 kU/L.
  • Stable asthma treatments.
  • Spirometry with best FEV1 > 70% of the predicted value.
  • Spirometry with reversibility of FEV1 of ≥ 12% and ≥ 200 mL.
  • Asthma Control Test™ (ACT) score ≥ 20.

Exclusion Criteria:

  • Current smoker or former smoker with > 10 pack/year history.
  • Co-sensitisation to any allergen possibly leading to clinically relevant respiratory allergy likely to significantly change the symptoms of the patient throughout the treatment period.
  • 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.
  • Patient with any oral condition that could confound the safety assessments or planning to have a dental extraction during the study.
  • Female patient pregnant or breast-feeding/lactating.
  • Female patient of childbearing potential not using a medically accepted contraceptive method.
  • Patient treated with beta-blockers, tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs).
  • Patient who received allergen immunotherapy for HDM in the last 10 years.
  • Ongoing treatment by immunotherapy with another allergen.

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
Biological: Matching placebo
10 dosing days
EXPERIMENTAL: SLIT tablets of HDM allergen extracts
Biological: SLIT tablets of house dust mite allergen extracts
10 dosing days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety, tolerability as indicated by adverse events and safety laboratory evaluation
Time Frame: 10 dosing days
10 dosing days

Collaborators and Investigators

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

Sponsor

Stallergenes Greer

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

May 1, 2012

Primary Completion (ACTUAL)

June 1, 2014

Study Completion (ACTUAL)

June 1, 2014

Study Registration Dates

First Submitted

May 25, 2012

First Submitted That Met QC Criteria

May 25, 2012

First Posted (ESTIMATE)

May 31, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

July 1, 2014

Last Update Submitted That Met QC Criteria

June 30, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VO71.11

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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