Dose Ranging Study of SLIT Tablets of House Dust Mite Allergen Extracts (HDM) in Adults With HDM-associated Allergic Asthma

A Dose Ranging Study Investigating the Efficacy and Safety 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 efficacy and safety of different doses of sublingual tablets of house dust mite allergen extracts as compared to placebo in adults with house dust mite-associated allergic asthma.

Study Overview

• Status: Completed
• Conditions: Asthma; House Dust Mite Allergy
• Intervention / Treatment: Biological: SLIT tablets of HDM allergen extracts, 3 different doses (A); Biological: SLIT tablets of HDM allergen extracts, 3 different doses (B); Biological: SLIT tablets of HDM allergen extracts, 3 different doses (C); Biological: Placebo matching the SLIT tablets of HDM allergen extracts

• Study Type: Interventional
• Enrollment (Actual): 386
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • CHU Arnaud de Villeneuve
  • Strasbourg, France, 67091
    • NHC, Hôpitaux Universitaires de Strasbourg
• Germany
  • Berlin, Germany, 10117
    • Universitätsmedizin Berlin - Allergie-Centrum-Charité
• Poland
  • Lodz, Poland, 90-153
    • SPZOZ Uniwersytecki Szpital Kliniczny Nr 1im.N.Barlickiego w Uniwersystetu Medycznego w Łodzi
  • Tarnow, Poland, 33-100
    • Majorek-Olechowska Bernadetta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Written informed consent.
• Male or female from 18 to 50 years of age.
• Diagnosed asthma and rhinitis with medical history consistent with HDM-induced allergic asthma and rhinitis.
• Positive SPT to HDM and and HDM-specific IgE serum value ≥ 0.7 kU/L.
• Stable asthma therapies.
• Spirometry (pre-bronchodilator) with best FEV1 ≥ 70% of the predicted value.
• Spirometry with reversibility in FEV1 of ≥ 12% and ≥ 200 mL.
• Asthma Control Test™ (ACT) score ≤ 19.

Exclusion Criteria:

• Former smoker with > 10 pack year history or current smoker.
• Patient with a urine level of cotinine ≥ 500 ng/mL.
• Co-sensitisation to any allergen possibly leading to clinically relevant symptoms likely to significantly change the asthma symptoms of the subject during the study.
• Patient who received allergen immunotherapy for HDM within the past 10 years.
• Ongoing immunotherapy for an aeroallergen other than house dust mite.
• Patient with any oral condition that could confound the safety assessments or planning to have a dental extraction during the study.
• Patient treated with beta-blockers, tricyclic antidepressants or monoamine oxidase inhibitors (MAOIs).
• Pregnant women or breast-feeding/lactating.
• Women with childbearing potential who are not using a medically accepted birth control method.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: SLIT (A); SLIT tablets of HDM allergen extracts, 3 different doses (A)	Biological: SLIT tablets of HDM allergen extracts, 3 different doses (A); Two sublingual tablets daily for 13 months; Other Names: Sublingual immunotherapy tablet
EXPERIMENTAL: SLIT (B); SLIT tablets of HDM allergen extracts, 3 different doses (B)	Biological: SLIT tablets of HDM allergen extracts, 3 different doses (B); Two sublingual tablets daily for 13 months; Other Names: Sublingual immunotherapy tablet
EXPERIMENTAL: SLIT (C); SLIT tablets of HDM allergen extracts, 3 different doses (C)	Biological: SLIT tablets of HDM allergen extracts, 3 different doses (C); Two sublingual tablets daily for 13 months; Other Names: Sublingual immunotherapy tablet
PLACEBO_COMPARATOR: Placebo; Placebo matching the SLIT tablets of HDM allergen extracts	Biological: Placebo matching the SLIT tablets of HDM allergen extracts; Two sublingual tablets daily for 13 months; Other Names: Sublingual placebo tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect on the Asthma control test (ACT) score	Assessment of the effect of one year of treatment of 3 different doses of sublingual immunotherapy tablets of house dust mite (HDM) allergen extracts as compared to placebo on the Asthma Control Test™ (ACT) score, in adults with HDM-associated allergic asthma	13 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Number and percentage of subjects with treatment-emergent AEs	Measured during 13 months

Other Outcome Measures

Outcome Measure	Time Frame
Changes of Immunological parameters (HDM-specific IgE and IgG4 values)	13 months

Collaborators and Investigators

• Sponsor: Stallergenes Greer
• Investigators: Principal Investigator: Pascal Demoly, MD, Montpellier, France

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (ACTUAL): June 1, 2015
• Study Completion (ACTUAL): August 1, 2015

Study Registration Dates

• First Submitted: August 16, 2013
• First Submitted That Met QC Criteria: August 23, 2013
• First Posted (ESTIMATE): August 29, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): December 18, 2015
• Last Update Submitted That Met QC Criteria: December 17, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Immunologic Factors
• Other Study ID Numbers: VO72.12