Asthma pill for kids shows promise in early trial
NCT ID NCT03650400
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at how a new chewable asthma tablet called fevipiprant works in children aged 6 to 12. The goal was to measure the drug's levels in the body and check for safety. Only 11 children took part before the study was stopped early.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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11 people
The number who actually took part.
- Started
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May 2019
- Finished
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Jan 2020
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 to 11 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Children * Written informed consent by parent(s)/legal guardian(s) for the pediatric patient and assent by the pediatric patient (depending on local requirements) must be obtained before any study-specific assessment is performed. * Confirmed/documented diagnosis of asthma, as defined by national or international asthma guidelines for at least 6 months prior to study enrollment. * Subjects using asthma rescue medication (e.g. SABA) without asthma controller therapy or patients receiving daily treatment with a stable dose ICS (with or without additional controller such as long-acting β-agonists (LABA), long-acting muscarinic antagonists (LAMA)) for at least 4 weeks prior to Treatment Visit (Day 1). * Subjects must be able to attend study visits as per Study Visit Assessment Schedule (Section 8) which includes 8 to 9 hours in the clinic/home on the day of End of Treatment Visit and have blood draws as scheduled in the study. Exclusion Criteria: * Use of other investigational drugs within 5 half-lives of enrollment, or (within 30 days (for small molecules)/until the expected pharmacodynamic effect has returned to baseline (for biologics)), whichever is longer. * Subject is unable to ingest banana and/or yogurt * History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes. * History of chronic lung disease other than asthma such as and not limited to, sarcoidosis interstitial lung disease, cystic fibrosis, mycobacterial or other infection (including active tuberculosis or atypical mycobacterial disease). * History of active bacterial, viral or fungal infection within 6 weeks of Treatment Visit (Day 1).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Novartis Investigative Site
Minneapolis, Minnesota, 55402, United States
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Novartis Investigative Site
Columbia, Missouri, 65203, United States
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Novartis Investigative Site
Tulsa, Oklahoma, 74136, United States
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Novartis Investigative Site
Boerne, Texas, 78006, United States
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Novartis Investigative Site
El Paso, Texas, 79903, United States
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Novartis Investigative Site
San Antonio, Texas, 78229, United States
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