Clinical trial NCT01930461: Dose Ranging Study of SLIT Tablets of House Dust Mite Allergen Extracts (HDM) in Adults With HDM-associated Allergic Asthma
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
House Dust Mite Allergy
Lead sponsor: Stallergenes Greer
Sponsor class: INDUSTRY
First posted: 2013-08-29
Enrollment: 386
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Effect on the Asthma control test (ACT) score
timeFrame: 13 months
Secondary outcomes:
measure: Number and percentage of subjects with treatment-emergent AEs
timeFrame: Measured during 13 months
Other outcomes:
measure: Changes of Immunological parameters (HDM-specific IgE and IgG4 values)
timeFrame: 13 months
Locations:
city: Montpellier
country: France
facility: CHU Arnaud de Villeneuve
city: Strasbourg
country: France
facility: NHC, Hôpitaux Universitaires de Strasbourg
city: Berlin
country: Germany
facility: Universitätsmedizin Berlin - Allergie-Centrum-Charité
city: Lodz
country: Poland
facility: SPZOZ Uniwersytecki Szpital Kliniczny Nr 1im.N.Barlickiego w Uniwersystetu Medycznego w Łodzi
city: Tarnow
country: Poland
facility: Majorek-Olechowska Bernadetta
Study officials:
affiliation: Montpellier, France
name: Pascal Demoly, MD
role: PRINCIPAL_INVESTIGATOR
References: