Rhinoconjunctivitis Clinical Trial
Official title:
An Optional Follow-Up Study to Evaluate the Continued Efficacy of ToleroMune HDM in House Dust Mite Allergic Subjects Following Challenge With House Dust Mite Allergen in an Environmental Exposure Chamber
House Dust Mites (HDM) are arachnids that infest bedding, carpet, upholstered furniture and
fabric. Like many other allergens, exposure to HDM allergens 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 HDM is currently being developed for the treatment of HDM allergy.
The Purpose of this optional observational follow-on study is to evaluate the continued
efficacy of TM-HDM in HDM allergic subjects based on change in TRSS from TH002 baseline
approximately two years after the completion of the baseline EEC visit in TH002 following
challenge with HDM allergen in an EEC.
Subjects who completed all dosing visits and the post treatment challenge (PTC) in study TH002 will be invited to attend the Screening visit for TH002a. Subjects will attend for 3 visits to the EEU on successive days. Following the last EEC visit a follow-up visit will be performed 3-10 days later. ;
Observational Model: Cohort, Time Perspective: Prospective
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