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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
386
Two sublingual tablets daily for 13 months
Two sublingual tablets daily for 13 months
Two sublingual tablets daily for 13 months
CHU Arnaud de Villeneuve
Montpellier, France
NHC, Hôpitaux Universitaires de Strasbourg
Strasbourg, France
Universitätsmedizin Berlin - Allergie-Centrum-Charité
Berlin, Germany
SPZOZ Uniwersytecki Szpital Kliniczny Nr 1im.N.Barlickiego w Uniwersystetu Medycznego w Łodzi
Lodz, Poland
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
Time frame: 13 months
Number and percentage of subjects with treatment-emergent AEs
Time frame: Measured during 13 months
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Two sublingual tablets daily for 13 months
Majorek-Olechowska Bernadetta
Tarnów, Poland