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

May 25, 2012
June 30, 2014
May 2012
June 2014   (final data collection date for primary outcome measure)
Safety, tolerability as indicated by adverse events and safety laboratory evaluation [ Time Frame: 10 dosing days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01608243 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety Study of Sublingual Immunotherapy Tablets of House Dust Mite Allergen Extracts
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Asthma
  • House Dust Mite Allergy
  • Biological: SLIT tablets of house dust mite allergen extracts
    10 dosing days
  • Biological: Matching placebo
    10 dosing days
  • Experimental: SLIT tablets of HDM allergen extracts
    Intervention: Biological: SLIT tablets of house dust mite allergen extracts
  • Placebo Comparator: Placebo
    Intervention: Biological: Matching placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
94
June 2014
June 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01608243
VO71.11
No
Stallergenes
Stallergenes
Not Provided
Principal Investigator: Pascal Demoly, MD CHU Arnaud de Villeneuve, Montpellier, France
Stallergenes
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP