Tiotropium vs. Inhaled Corticosteroids in Children With Nonatopic Asthma Pilot Study (TioNAAP)
Status:
Not yet recruiting
Trial end date:
2023-02-28
Target enrollment:
Participant gender:
Summary
Most children with asthma have concurrent atopy (allergic inflammation), which is associated
with an improved response to ICS. However, the absence of an atopic phenotype is associated
with a poorer ICS response, leaving clinicians with limited treatment options. The nonatopic
asthma phenotype has been characterized as the absence of atopic diseases including allergic
rhinitis, eczema, or food allergies, and a negative skin prick test to common aeroallergens.
Children with mild asthma treated with ICS over 44 weeks without a positive allergen skin
test are 3 times more likely to have an asthma exacerbation when compared with children with
positive skin tests. Similarly, adolescents and adults with asthma with low blood eosinophils
or low sputum eosinophils have no difference in exacerbation rate response to ICS compared
with placebo. Due to poor ICS response in nonatopic children and the known adverse effects of
ICS, the development of non-steroid treatments options is needed.
Monotherapy with the long-acting muscarinic antagonist, tiotropium, was superior to placebo
for treatment failure outcomes in adolescents and adults with low sputum eosinophil levels.
Tiotropium is approved in children as an add on therapy to ICS in children ≥ 6 years with
asthma. But, this combination of treatment would still expose children with nonatopic asthma
to the risks (but potentially without the benefit) of ICS therapy. The objective of this
study is to conduct a feasibility pilot safety study of 6-weeks treatment with tiotropium
monotherapy vs. ICS in children ages 6 to 11 years old with nonatopic mild persistent asthma.