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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
Intradermal injection 1 x 4 administrations 4 weeks apart
Intradermal injection 1 x 4 administrations 4 weeks apart
Topstone Research
Toronto, Ontario, Canada
Adverse Events
Time frame: Up to 19 Weeks
FEV1 and FVC
Time frame: Up to 19 Weeks
Peak Expiratory Flow Rate
Time frame: Up to 19 Weeks
VAS Breathlessness
Time frame: Up to 19 weeks
Asthma Exacerbations
Time frame: Up to 19 weeks
Systemic Allergic Reactions
Time frame: Up to 19 Weeks
Injection Site Examinations
Time frame: Up to 19 Weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.