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NCT04990167 · ClinicalTrials.gov registry record · Phase 2
Tiotropium vs. Inhaled Corticosteroids in Children With Nonatopic Asthma Pilot Study (TioNAAP)
A Phase 2 study, sponsored by Nemours Children's Clinic.
- Terminated
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT04990167 is a Phase 2 study that was terminated before completion, run by Nemours Children's Clinic. The registered enrollment target is 11 participants.
The verdict
NCT04990167, a Phase 2 study, was terminated before completion, sponsored by Nemours Children's Clinic.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study 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.
Interventions
- DRUG Tiotropium Bromide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2022-01-01 |
| Est. Completion | 2025-10-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04990167
The ClinicalTrials.gov registry entry for NCT04990167 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nemours Children's Clinic, which has 108 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Tiotropium Bromide is the first listed.
NCT04990167 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04990167 about?
NCT04990167 is a clinical study titled "Tiotropium vs. Inhaled Corticosteroids in Children With Nonatopic Asthma Pilot Study (TioNAAP)". 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 b...
What is the current status of trial NCT04990167?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2022-01-01. Estimated completion is 2025-10-31.
What interventions are being tested in trial NCT04990167?
The interventions under investigation include: Tiotropium Bromide (DRUG).
Who is sponsoring clinical trial NCT04990167?
This trial is sponsored by Nemours Children's Clinic, which has 108 total clinical trials registered on ClinicalTrials.gov.
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