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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: Clinical Trial Phase 2 study, sponsored by Nemours Children's Clinic.
NCT04990167 is a Phase 2 study that was terminated before completion, run by Nemours Children's Clinic. The registered enrollment target is 11 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary outcome is change in asthma control from baseline to the end of 6-weeks treatment with tiotropium versus ICS. Asthma control will be assessed by the Childhood Asthma Control Test (c-ACT) score. The c-ACT is well validated for assessing asthma control in children aged 4-11 years.41 The c-ACT ranges from 0 to 27; a score of 19 indicates inadequately controlled 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 |
Why NCT04990167 stopped before completion
NCT04990167 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Tiotropium Bromide is the first listed.
NCT04990167 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04990167's enrollment target sits among peer trials
11 1967th of 2000 higher than 33 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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