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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01608243
• Other study ID #: VO71.11
• Status: Completed
• Phase: Phase 1
• First received: May 25, 2012
• Last updated: June 30, 2014
• Start date: May 2012
• Est. completion date: June 2014

Study information

• Verified date: June 2014
• Source: Stallergenes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Asthma
• House Dust Mite Allergy

Intervention

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

Locations

Country	Name	City	State
France	CHU Arnaud de Villeneuve	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Stallergenes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety, tolerability as indicated by adverse events and safety laboratory evaluation		10 dosing days	Yes