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

This study has been completed.
Information provided by (Responsible Party):
Stallergenes Identifier:
First received: May 25, 2012
Last updated: June 30, 2014
Last verified: June 2014

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.

Condition Intervention Phase
House Dust Mite Allergy
Biological: SLIT tablets of house dust mite allergen extracts
Biological: Matching placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Stallergenes:

Primary Outcome Measures:
  • Safety, tolerability as indicated by adverse events and safety laboratory evaluation [ Time Frame: 10 dosing days ] [ Designated as safety issue: Yes ]

Enrollment: 94
Study Start Date: May 2012
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SLIT tablets of HDM allergen extracts Biological: SLIT tablets of house dust mite allergen extracts
10 dosing days
Placebo Comparator: Placebo Biological: Matching placebo
10 dosing days


Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01608243

CHU Arnaud de Villeneuve
Montpellier, France, 34295
Sponsors and Collaborators
Principal Investigator: Pascal Demoly, MD CHU Arnaud de Villeneuve, Montpellier, France
  More Information

No publications provided

Responsible Party: Stallergenes Identifier: NCT01608243     History of Changes
Other Study ID Numbers: VO71.11
Study First Received: May 25, 2012
Last Updated: June 30, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé processed this record on October 08, 2015