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House Dust Mites (HDMs) are arachnids that infest bedding, carpet, upholstered furniture and fabric. Like many other allergens, exposure to HDMA in sensitised patients is associated with poorer lung function, greater medication requirements and more asthma symptoms as well as chronic rhinosinusitis symptoms. In contrast to other allergens, there is evidence that HDMA leads to the development of asthma, in addition to exacerbating pre-existing asthma in HDM-sensitised patients.
ToleroMune House Dust Mite (TM-HDM), a combination of seven Synthetic Peptide Immuno-Regulatory Epitopes, is being developed for the treatment of HDM allergy.
This study to assess the tolerability of ToleroMune House Dust Mite in subjects with controlled asthma and house dust mite-induced rhinoconjunctivitis.
Full description
A multi-centre, randomised, double-blind, placebo-controlled, parallel-group, multiple dose study to evaluate the tolerability of four intradermal doses of TM-HDM in subjects with controlled asthma and HDM-induced rhinoconjunctivitis.
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Inclusion criteria
Exclusion criteria
History of life-threatening asthma
Asthma exacerbation in the 12 weeks prior to randomisation
Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) < 80 % of predicted, regardless of the cause.
Post-bronchodilator FEV1/Forced Vital Capacity ratio of < 0.7.
Concurrent respiratory disease that would confound study participation or affect subject safety.
Non-HDM allergy that may significantly interfere with the results of this study.
Primary purpose
Allocation
Interventional model
Masking
30 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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