Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Can a smart inhaler deliver better asthma care for kids?

NCT ID NCT06290102

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

30 people

The number who actually took part.

Started

May 2024

Finished

Oct 2024

Lead sponsor

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

Anyone

Healthy volunteers

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

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Asthma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

  • Teva Investigational Site 12001

    Boerne, Texas, 78006, United States

  • Teva Investigational Site 12002

    Miami, Florida, 33155, United States

  • Teva Investigational Site 12003

    Long Beach, California, 90815, United States

  • Teva Investigational Site 12005

    Miami, Florida, 33142, United States

  • Teva Investigational Site 12007

    Miami, Florida, 33130, United States

  • Teva Investigational Site 12008

    Lafayette, Louisiana, 70508, United States

  • Teva Investigational Site 12009

    San Antonio, Texas, 78249, United States

  • Teva Investigational Site 12010

    Mobile, Alabama, 36608, United States

  • Teva Investigational Site 12011

    Columbia, Missouri, 65203, United States

  • Teva Investigational Site 12012

    Oklahoma City, Oklahoma, 73120-9389, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.