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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01608243
Recruitment Status : Completed
First Posted : May 31, 2012
Last Update Posted : July 1, 2014
Information provided by (Responsible Party):
Stallergenes Greer

Brief Summary:
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 or disease Intervention/treatment Phase
Asthma House Dust Mite Allergy Biological: SLIT tablets of house dust mite allergen extracts Biological: Matching placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : May 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Odactra
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Safety, tolerability as indicated by adverse events and safety laboratory evaluation [ Time Frame: 10 dosing days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01608243

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

Responsible Party: Stallergenes Greer Identifier: NCT01608243     History of Changes
Other Study ID Numbers: VO71.11
First Posted: May 31, 2012    Key Record Dates
Last Update Posted: July 1, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases