CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 306 enrolled
Drug / intervention
Lansoprazole +1 moredrug
Likely dose
Lansoprazole 15 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00442013
NCT00442013Phase 4Completed
CompareCT.gov

Phase III: The Study of Acid Reflux in Children With Asthma

Johns Hopkins University·interventional·Posted Mar 1, 2007·Updated Dec 6, 2012

In Brief

A Phase 4 clinical trial evaluating Lansoprazole and Matching placebo for Asthma. Completed, enrolled 306 participants across 20 sites.

Detailed Summary

Many individuals with asthma also experience gastroesophageal reflux disease (GERD), a condition in which excess stomach acid flows backwards into the esophagus. This study will evaluate the effectiveness of lansoprazole, a medication commonly used to treat GERD in improving asthma control and reducing symptoms in children with poorly controlled asthma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited States
CollaboratorsAmerican Lung Association Asthma Clinical Research Centers, National Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 1, 2007
Enrollment StartMar 1, 2007
Primary CompletionApr 1, 2011
Study CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 19.3 years ago

Interventions

Lansoprazoledrug

Participants less than 30 kg will receive 15 mg a day, by mouth; participants greater than or equal to 30 kg will receive 30 mg a day, by mouth.

Matching placebodrug

Participants will receive a placebo pill on a daily basis. To maintain masking, there are two doses of the matching placebo provided to participants depending on participant body weight at randomization: 1.) less than 30kg will receive 15mg po once daily or 2.)greater or equal to 30kg 30mg po once daily.