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Gene-Guided reflux drug may tame childhood asthma

NCT ID NCT03015610

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested whether adjusting the dose of a common acid reflux medicine (lansoprazole) based on a child's genes could improve asthma control. 41 children aged 6-17 with uncontrolled asthma and mild reflux participated. Researchers measured changes in asthma symptoms and reflux over 24 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lansoprazole
What this could lead to
If successful, this could lead to personalized dosing of acid reflux medicine to better control asthma in children.
What could go wrong
This is a small, completed Phase 3 trial with only 41 participants, so results may not apply to all children. The benefit of gene-guided dosing over standard care remains uncertain.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

41 people

The number who actually took part.

Started

Oct 2017

Finished

Jan 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 17 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: * Age: 6-17 year olds with documented clinician-diagnosed asthma * Evidence of recent uncontrolled asthma (must meet at least one of the following). This convention for defining poorly-controlled asthma has been successfully used in a large pediatric trial. * ACQ \> 1.2 * Use of short-acting beta-agonist for asthma symptoms twice/week or more on average over the past month * Nocturnal awakenings with asthma symptoms more than once per week on average over the last month * Two or more emergency department visits, unscheduled provider visits, prednisone courses or hospitalizations for asthma in the past 12 months * Currently on stable dose of daily inhaled corticosteroid medication (ICS) for asthma control equivalent to 88mcg of fluticasone or greater for at least 6 weeks from the time of enrollment. Participant must be on National Asthma Education and Prevention Program (NAEPP) controller step 2, 3 or 4. * Currently with mild GERD symptoms reported at V1 defined by a score on the Pediatric GERD Symptom Assessment Score greater than 15 and less than 80. GSAS ranges from 0 to \>440. Exclusion Criteria: * Taking daily CYP2C19 substrates, inducers or inhibitors medication * Past or current history of moderate-severe GERD or related disorders (erosive esophagitis, peptic ulcer disease, eosinophilic esophagitis) which in the opinion of the pediatric gastroenterology safety specialist/study physician requires treatment with acid-blocking agents; * Daily use of a PPI for more than 4 consecutive weeks in the past 6 months; * previous intubation for asthma, * admission to intensive care unit for more than 24 hours for asthma in the past year, * Previous surgery involving the esophagus or stomach (anti-reflux surgery, peptic ulcer surgery, trachea-esophageal fistula repair); * Forced expiratory volume in 1 second (FEV1) \< 60% of predicted at enrollment; * Any major chronic illness that would interfere with participation in the intervention or completion of the study procedures; * History of phenylketonuria (PKU); * Medication use: treatment of GERD symptoms with over-the-counter antacids 4 days/week or more on average over past month; * Theophylline preparations, azoles, anti-coagulants, insulin for Type 1 diabetes, digitalis, oral iron supplements when administered for iron deficiency within 1 month; * Any investigational drugs within the past 2 months; * Drug Allergies: previous allergic reaction from lansoprazole or other proton pump inhibitor medication or adverse reaction to aspartame; * Inability to complete baseline measurements in a satisfactory manner according to the judgment of the research coordinator or site PI; * Less than 75% completion of daily diary for asthma symptoms, SABA use and ICS medication adherence during the run-in period; * Plan for family to move from study location within the next 6 months.

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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

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Nemours Children's Specialty Care

    Jacksonville, Florida, 32207, United States

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