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Can a smart inhaler deliver better asthma care for kids?
NCT ID NCT06290102
First seen Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time
Summary
This trial is testing a new inhaler that combines two asthma medications—fluticasone propionate and albuterol sulfate—in a single device with an electronic module. The study involves children aged 4 to 11 with stable asthma. The goal is to measure how much of the medication gets into the body and to compare it with an existing inhaler. The study also checks for any side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- fluticasone propionate and albuterol sulfate combination inhaler
- What this could lead to
- If successful, this could lead to a more convenient and effective inhaler for children with asthma, potentially improving symptom control.
- What could go wrong
- This is an early-stage trial with a small number of participants, so results may not apply to all children. The study focuses on drug levels and safety, not long-term effectiveness.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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30 people
The number who actually took part.
- Started
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May 2024
- Finished
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Oct 2024
- 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
-
4 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.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participant has a diagnosis of asthma as defined by the Global Initiative for Asthma guidelines (GINA 2023), which has been present for a minimum of 3 months and has been stable (defined as no exacerbations and no changes in asthma medication) for at least 30 days before the Screening Visit * Has persistent asthma, with a forced expiratory value (FEV1) that is greater than or equal to 80% of the value predicted for age, height, sex, and race at the Screening Visit * Demonstrate acceptable inhalation technique with the training inhaler * Able to stop (as judged by the Investigator) his or her rescue medication, for approximately 6 hours before the Screening Visit and for approximately 4 hours before training sessions in periods 1-3 * Has body mass index (BMI) within the 3rd and 97th percentiles for the participant's age and gender. The participant must have a weight of ≥18 kilograms (kg) * Able to achieve a peak inspiratory flow (PIF) rate of at least 60 liters per minute (L/min) on an inhaler training device NOTE- Additional criteria apply, please contact the investigator for more information Exclusion Criteria: * Participant has a history of a life-threatening asthma exacerbation that is defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest, or hypoxic seizures * Has participated as a randomized participant in any investigational drug trial within 30 days (starting from the final follow-up visit of that trial) preceding the Screening Visit or plans to participate in another investigational drug trial at any time during this trial * Known hypersensitivity to any corticosteroid, albuterol, or any of the ingredients in the investigational medicinal product * Asthma exacerbation requiring systemic corticosteroids within 30 days of the Screening Visit, or has had any hospitalization for asthma within 2 months of the Screening Visit NOTE- Additional criteria apply, please contact the investigator for more information
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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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Teva Investigational Site 12001
Boerne, Texas, 78006, United States
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Teva Investigational Site 12002
Miami, Florida, 33155, United States
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Teva Investigational Site 12003
Long Beach, California, 90815, United States
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Teva Investigational Site 12005
Miami, Florida, 33142, United States
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Teva Investigational Site 12007
Miami, Florida, 33130, United States
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Teva Investigational Site 12008
Lafayette, Louisiana, 70508, United States
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Teva Investigational Site 12009
San Antonio, Texas, 78249, United States
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Teva Investigational Site 12010
Mobile, Alabama, 36608, United States
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Teva Investigational Site 12011
Columbia, Missouri, 65203, United States
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Teva Investigational Site 12012
Oklahoma City, Oklahoma, 73120-9389, United States
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