Reflux Disease Therapy in the Management of Childhood Asthma-data Entry and Analysis Only
There have been a number of studies which attribute causality between reflux disease and asthma. In addition, clinicians typically treat chronic asthmatics with high dose acid suppressing medications (e.g. lansoprazole). However, clinical trials only recently have shed some light on this dilemma, with recent studies suggesting that the association is not as clear. This "retrospective" analysis of a prospective study which treated mod-severe asthmatics with lansoprazole or placebo will enter the collected raw data into a database, then perform statistical analyses to determine if children with asthma treated with acid suppression improved their asthma compared to those receiving placebo.
Gastroesophageal Reflux Disease
|Study Design:||Time Perspective: Retrospective|
|Official Title:||Data Analysis of a Randomized, Double-Blind, Placebo- Controlled Study of Gastroesophageal Reflux Disease Therapy (Lansoprazole; Solutab™) in the Management of Childhood Asthma|
- Asthma exacerbations in the treatment group [ Time Frame: Over 21 months ] [ Designated as safety issue: No ]This is a retrospective study. We will be entering data collected in a prospective clinical trial and then analyzing such data to determine if intervention with acid suppression, lansoprazole improves the number of asthma exacerbation in a one year period compared to those receiving placebo.
|Study Start Date:||July 2011|
|Study Completion Date:||January 2013|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01536457
|United States, Georgia|
|Children's Center for Digestive Health Care|
|Atlanta, Georgia, United States, 30342|
|Principal Investigator:||Benjamin D Gold, M.D.||Children's Center for Digestive Health Care|