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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stallergenes
ClinicalTrials.gov Identifier:
NCT01608243
First received: May 25, 2012
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

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
Asthma
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

Resource links provided by NLM:


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

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01608243

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

No publications provided

Responsible Party: Stallergenes
ClinicalTrials.gov 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

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

ClinicalTrials.gov processed this record on September 30, 2014