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NCT03015610 · ClinicalTrials.gov registry record · Phase 3
Genotype-tailored Treatment of Symptomatic Acid-Reflux in Children With Uncontrolled Asthma
A Phase 3 study of Asthma and Gastroesophageal Reflux, sponsored by Jason Lang, M.D., M.P.H..
- Completed
- Registry status
- Phase 3
- Development phase
- 41
- Enrollment target
- 2
- Study locations
NCT03015610: Completed Phase 3 study of Asthma and Gastroesophageal Reflux, sponsored by Jason Lang, M.D., M.P.H..
NCT03015610 is a Phase 3 study of Asthma and Gastroesophageal Reflux that has completed, run by Jason Lang, M.D., M.P.H.. The registered enrollment target is 41 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (97% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03015610, a Phase 3 study of Asthma and Gastroesophageal Reflux, has completed, sponsored by Jason Lang, M.D., M.P.H..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 41 participants
- Enrollment target
- 2
- Study locations
Study Summary
This study will evaluate the effect of CYP2C19 and ABCB1 genes on pharmacokinetics of lansoprazole in children with mild gastroesophageal reflux (GER) and uncontrolled asthma. It will determine if genotype-guided lansoprazole dosing of lansoprazole improves GER and asthma control.
Primary Outcome
The ACQ considers a broad set of common indicators of asthma control including use of bronchodilators, cough, nocturnal symptoms, level of activity, and pulmonary function. Scores range between 0 (totally controlled) and 6 (severely uncontrolled). Reported is the change from week 0 to week 26; a negative change value indicates an improvement in asthma control.
Conditions Studied
Interventions
- DRUG commercially available lansoprazole
- DRUG matched placebo
Study Locations (2)
Florida
- Nemours Children's Specialty Care - Jacksonville
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2017-10-31 |
| Est. Completion | 2024-01-18 |
| Phase | Phase 3 |
What the finished NCT03015610 record still lists
NCT03015610 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Asthma appearing as the primary indexed condition, and to 2 interventions - of which commercially available lansoprazole is the first listed.
NCT03015610 reports a single indexed study location in Florida, North Carolina.
Frequently Asked Questions
What is clinical trial NCT03015610 about?
NCT03015610 is a clinical study titled "Genotype-tailored Treatment of Symptomatic Acid-Reflux in Children With Uncontrolled Asthma". This study will evaluate the effect of CYP2C19 and ABCB1 genes on pharmacokinetics of lansoprazole in children with mild gastroesophageal reflux (GER) and uncontrolled asthma. It will determine if genotype-guided lansoprazole dosing of lansoprazole improves GER and asthma control.
What is the current status of trial NCT03015610?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 41 participants. The study started on 2017-10-31. Estimated completion is 2024-01-18.
What conditions does trial NCT03015610 study?
This clinical trial studies the following conditions: Asthma, Gastroesophageal Reflux.
What interventions are being tested in trial NCT03015610?
The interventions under investigation include: commercially available lansoprazole (DRUG), matched placebo (DRUG).
Who is sponsoring clinical trial NCT03015610?
This trial is sponsored by Jason Lang, M.D., M.P.H., which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03015610 being conducted?
This trial has 2 study locations across Florida, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Asthma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03015610's enrollment target sits among peer trials
41 281st of 374 higher than 94 of 374 other Asthma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Asthma 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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