Tiotropium vs. Inhaled Corticosteroids in Children With Nonatopic Asthma Pilot Study

1753113-1

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.

2022-01-01

2024-07-28

2024-07-28

Recruiting

Early phase I

26

Inclusion Criteria: 1. Children ages 6 to 11 years with controlled mild nonatopic persistent physician diagnosed asthma 1. Non-atopic asthma: absence of a positive SPT to inhaled aeroallergens or negative specific IgE to a common regional allergen panel; historical serum IgE less than 200 IU/ml; historical serum eosinophils less than 350 cells per microliter (cells/mcL); no history of eczema; no history of allergic rhinitis; no history of food allergy 2. Physician-diagnosed asthma: positive family history, recurrent asthma symptoms, bronchodilator responsiveness, and evidence of obstruction. 3. Mild persistent asthma: current treatment with as-needed albuterol or low-dose ICS or daily montelukast (Step 2 therapy) 4. Controlled asthma: Childhood Asthma Control Test score \>19 2. Pre-bronchodilator FEV1 ≥ 80% of predicted Exclusion Criteria: 1. Oral corticosteroid use in the past 6 weeks 2. Use of ICS in combination with long-acting beta agonist or montelukast 3. History of life-threatening asthma requiring treatment with intubation or mechanical ventilation within the past 5 years 4. Respiratory tract infection within the past 4 weeks 5. Any other chronic diseases or medical conditions (other than asthma) that in the opinion of the investigator would prevent participation in a trial

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This is a prospective, randomized, open-label crossover pilot feasibility trial.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 26, 'type': 'ESTIMATED'}}

2024-03-27