Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00237068
Status:
UNKNOWN
Last Update Posted:
2011-03-16
First Post:
2005-10-11
Brief Title:
A Randomized Double-Blind Placebo-Controlled Study of Gastroesophageal Reflux Disease Therapy
Sponsor:
Emory University
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Study of Gastroesophageal Reflux Disease Therapy Lansoprazole Solutab in the Management of Childhood Asthma
Status:
UNKNOWN
Status Verified Date:
2011-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Asthma and gastroesophageal reflux disease GERD are common disorders which although are not usually lethal both have high morbidity and high healthcare costs Recent studies have demonstrated that asthma and GERD often co-exists and that this co-existence is more frequent than just chance Therefore studies that characterize associations between these conditions and help in the development of interventions will positively impact the outcomes of these patients which are critically needed
Subjects that participate in this study are required to be between the ages of 4-11 years old This protocol proposes to enroll 100 children with asthma on inhaled steroids who have poor asthma control defined on the basis of frequent symptoms excessive beta-agonists use or frequent asthma episodes
The purpose of this research study is to
1 Determine whether children with symptomatic poorly controlled asthma assigned to treatment with a PPI Proton Pump Inhibitor have fewer asthma exacerbations than similar participants assigned to placebo for a similar duration of time
2 Determine whether children treated with Lansoprazole ie proton pump inhibitor have a longer time to first exacerbation have improved lung function improved asthma symptom scores improved quality of life decreased rescue inhaler use or other asthma medications reduced emergency roomurgent care physician office visits that are asthma related
3 Determine whether a subgroup of symptomatic asthmatics who show a greater benefit from PPIs can be identified
Subjects that participate in this study are required to be between the ages of 4-11 years old This protocol proposes to enroll 100 children with asthma on inhaled steroids who have poor asthma control defined on the basis of frequent symptoms excessive beta-agonists use or frequent asthma episodes
The purpose of this research study is to
1 Determine whether children with symptomatic poorly controlled asthma assigned to treatment with a PPI Proton Pump Inhibitor have fewer asthma exacerbations than similar participants assigned to placebo for a similar duration of time
2 Determine whether children treated with Lansoprazole ie proton pump inhibitor have a longer time to first exacerbation have improved lung function improved asthma symptom scores improved quality of life decreased rescue inhaler use or other asthma medications reduced emergency roomurgent care physician office visits that are asthma related
3 Determine whether a subgroup of symptomatic asthmatics who show a greater benefit from PPIs can be identified
Detailed Description:
GERD and asthma likely co-exist and may be pathogenetically linked However it is controversial whether GERD per se is an important risk factor for severe asthma and whether treatment of GERD andor GERD symptoms improves asthma control In addition there are no published data on how often asthmatics are treated with the anti-secretory agents proton pump inhibitors PPIs for GERD However a preliminary survey from the American Lung Associations Asthma Clinical Research Centers consortium show diverse practice patterns among clinics with about 15 of children and 20 - 30 of adults being prescribed medical treatment unpublished data
The NIH Expert Panel on The Diagnosis and Management of Asthma recommends that for patients with poorly controlled asthma particularly with a nocturnal component investigation for gastroesophageal reflux may be warranted even in the absence of suggestive symptoms The American Thoracic Society ATS workshop on severe refractory asthma concluded that GERD could contribute to the severity of asthma and recommended that all patients with severe refractory asthma undergo esophageal pH probe monitoring to evaluate for the presence of GERD Noticeably absent in both of these expert panel documents were randomized placebo controlled trial data in all populations and properly designed clinical trial information in the pediatric population with clear case and control definitions of GERD and asthma The American Gastroenterological Association recommends ambulatory pH probe monitoring in adult patients with reflux-triggered asthma but to date has developed no recommendations for children 20 While these are reasonable recommendations there is no convincing evidence that GERD is more common in patients with severe asthma than mild asthma or that treatment of reflux can decrease asthma severity PPIs the most effective treatment for GERD ie resolve both symptoms and mucosal disease have a retail cost between 100 and 153 per month However recent hospital data demonstrates that anti-reflux surgery is being performed at an increasing rate in children with respiratory manifestations of their GERD at a sizeable cost and with no long term outcome studies to date Thus it can be estimated that the cost for diagnosing and treating GERD in symptomatic asthmatics ranges from 1 to 8 billion dollars per year if all poorly controlled asthmatics were both investigated and treated Therefore randomized controlled clinical trials are critically needed to reduce overall healthcare costs and the public health burden of these two chronic conditions
The NIH Expert Panel on The Diagnosis and Management of Asthma recommends that for patients with poorly controlled asthma particularly with a nocturnal component investigation for gastroesophageal reflux may be warranted even in the absence of suggestive symptoms The American Thoracic Society ATS workshop on severe refractory asthma concluded that GERD could contribute to the severity of asthma and recommended that all patients with severe refractory asthma undergo esophageal pH probe monitoring to evaluate for the presence of GERD Noticeably absent in both of these expert panel documents were randomized placebo controlled trial data in all populations and properly designed clinical trial information in the pediatric population with clear case and control definitions of GERD and asthma The American Gastroenterological Association recommends ambulatory pH probe monitoring in adult patients with reflux-triggered asthma but to date has developed no recommendations for children 20 While these are reasonable recommendations there is no convincing evidence that GERD is more common in patients with severe asthma than mild asthma or that treatment of reflux can decrease asthma severity PPIs the most effective treatment for GERD ie resolve both symptoms and mucosal disease have a retail cost between 100 and 153 per month However recent hospital data demonstrates that anti-reflux surgery is being performed at an increasing rate in children with respiratory manifestations of their GERD at a sizeable cost and with no long term outcome studies to date Thus it can be estimated that the cost for diagnosing and treating GERD in symptomatic asthmatics ranges from 1 to 8 billion dollars per year if all poorly controlled asthmatics were both investigated and treated Therefore randomized controlled clinical trials are critically needed to reduce overall healthcare costs and the public health burden of these two chronic conditions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None