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

Phase 2

Completed

• Conditions: House Dust Mite Allergy; Asthma
• Interventions: 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

• Registration Number: NCT01930461
• Lead Sponsor: Stallergenes Greer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-16
• Study First Submitted QC: 2013-08-23
• Study First Posted: 2013-08-29
• Study Start: 2013-09
• Primary Completion: 2015-06
• Study Completion: 2015-08
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-17
• Last Update Posted: 2015-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 386

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SLIT (A)	SLIT tablets of HDM allergen extracts, 3 different doses (A)	SLIT tablets of HDM allergen extracts, 3 different doses (A)
SLIT (B)	SLIT tablets of HDM allergen extracts, 3 different doses (B)	SLIT tablets of HDM allergen extracts, 3 different doses (B)
SLIT (C)	SLIT tablets of HDM allergen extracts, 3 different doses (C)	SLIT tablets of HDM allergen extracts, 3 different doses (C)
Placebo	Placebo matching the SLIT tablets of HDM allergen extracts	Placebo matching the SLIT tablets of HDM allergen extracts

Primary Outcome Measures

Name	Time	Method
Effect on the Asthma control test (ACT) score	13 months	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

Secondary Outcome Measures

Name	Time	Method
Number and percentage of subjects with treatment-emergent AEs	Measured during 13 months

Trial Locations

Locations (5)

Majorek-Olechowska Bernadetta; 🇵🇱 Tarnow, Poland

SPZOZ Uniwersytecki Szpital Kliniczny Nr 1im.N.Barlickiego w Uniwersystetu Medycznego w Łodzi; 🇵🇱 Lodz, Poland

NHC, Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France

CHU Arnaud de Villeneuve; 🇫🇷 Montpellier, France

Universitätsmedizin Berlin - Allergie-Centrum-Charité; 🇩🇪 Berlin, Germany