Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00442013
Status:
COMPLETED
Last Update Posted:
2012-12-06
First Post:
2007-02-28
Brief Title:
Lansoprazole to Treat Children With Asthma
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Phase III The Study of Acid Reflux in Children With Asthma
Status:
COMPLETED
Status Verified Date:
2012-12
Last Known Status:
None
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:
SARCA
Brief 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
Detailed Description:
Approximately 75 of individuals with asthma also experience GERD If left untreated GERD can lead to lung damage esophageal ulcers or esophageal cancer Children and adults whose asthma is poorly controlled with inhaled corticosteroids are often prescribed drugs that suppress gastric acid production however this treatment is expensive and has not been proven beneficial Lansoprazole is a proton pump inhibitor medication that reduces stomach acid production It may also decrease the frequency of asthma exacerbations in children with poorly controlled asthma The purpose of this study is to evaluate the effectiveness of lansoprazole at improving asthma control quality of life and lung function in children with asthma
This study will enroll children with poor asthma control who are receiving inhaled corticosteroids Participants will be randomly assigned to receive either lansoprazole or placebo on a daily basis for 6 months Study visits will occur at baseline and Weeks 4 8 12 16 20 and 24 and participants will be contacted by telephone at Week 2 A physical examination blood collection and methacholine challenge test will occur at selected visits The methacholine challenge test will be used to help determine the severity of an individuals asthma Lung function and airway pressure testing questionnaires on asthma control and quality of life medical history review pill counts and distribution of medication will occur at most study visits Participants will record asthma symptoms and lung function in a daily diary throughout the study A select group of participants will also wear an esophageal potential Hydrogen pH monitor for 24 hours to evaluate GERD symptoms and the relationship between GERD and asthma symptoms
This study will enroll children with poor asthma control who are receiving inhaled corticosteroids Participants will be randomly assigned to receive either lansoprazole or placebo on a daily basis for 6 months Study visits will occur at baseline and Weeks 4 8 12 16 20 and 24 and participants will be contacted by telephone at Week 2 A physical examination blood collection and methacholine challenge test will occur at selected visits The methacholine challenge test will be used to help determine the severity of an individuals asthma Lung function and airway pressure testing questionnaires on asthma control and quality of life medical history review pill counts and distribution of medication will occur at most study visits Participants will record asthma symptoms and lung function in a daily diary throughout the study A select group of participants will also wear an esophageal potential Hydrogen pH monitor for 24 hours to evaluate GERD symptoms and the relationship between GERD and asthma symptoms
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01HL080450-01 | NIH | None | httpsreporternihgovquickSearchU01HL080450-01 |