Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00214552
Status:
COMPLETED
Last Update Posted:
2011-06-23
First Post:
2005-09-10
Brief Title:
Evaluate the Effects on Asthma Control of Rabeprazole Given Twice Daily in Subjects With Asthma
Sponsor:
Associated Scientists to Help Minimize Allergies
Organization:
Associated Scientists to Help Minimize Allergies
Study Overview
Official Title:
A Double-blind Placebo Controlled Clinical Trial to Evaluate the Effects on Asthma Control of Rabeprazole Given Twice Daily in Subjects With Asthma
Status:
COMPLETED
Status Verified Date:
2011-06
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:
None
Brief Summary:
The hypothesis for this study is that potent anti-secretory therapy with high dose PPI improves asthma control regardless of either asthma severity or the presence of GERD symptoms
Detailed Description:
Many patients with GERD do not experience heartburn symptoms Barium esophagram endoscopy andor overnight esophageal pH monitoring are commonly relied upon to objectively establish the diagnosis of GERD In general overnight esophageal pH monitoring is the most sensitive and specific test available to confirm GERD However the literature exploring GERD as a cause of chronic cough suggests that the currently accepted criteria for defining abnormal overnight esophageal pH may not be adequately sensitive It is therefore possible that aggressive GERD therapy may improve asthma control in patients with normal overnight esophageal pH probe results To our knowledge there are no published data addressing this question
Primary Objective The primary objective is to compare asthma control in asthmatic subjects treated with high dose PPI with asthmatic subjects taking placebo PPI The primary outcome variables will be measurements of asthma symptoms and asthma quality of life
Secondary Objectives Secondary objectives include evaluating the effect of this aggressive anti-secretory therapy on lung function asthma medication use including both baseline and rescue medication and GERD symptoms An additional secondary objective will be to evaluate whether the presence or absence of GERD symptoms at baseline prior to proton pump inhibitor therapy will independently associate with improvement in any of the other outcomes measured
Measurements will include Juniper Asthma Control Questionnaire visits 2 and 5 Juniper Asthma Quality of Life Questionnaire visits 2 - 5 GSAS gastroesophageal reflux instrument visit 2 visit 5 the occurrence of adverse events change in FVC FEF25-75 MIF50 MEF50 peak expiratory flow rate FEV1 reversibility and the physical exam
Additional measurements will include methacholine challenge and eosinophilia in induced sputum specimens Induced sputum will be offered to all patients though it is anticipated that only approximately 50 will agree to this procedure
Primary Objective The primary objective is to compare asthma control in asthmatic subjects treated with high dose PPI with asthmatic subjects taking placebo PPI The primary outcome variables will be measurements of asthma symptoms and asthma quality of life
Secondary Objectives Secondary objectives include evaluating the effect of this aggressive anti-secretory therapy on lung function asthma medication use including both baseline and rescue medication and GERD symptoms An additional secondary objective will be to evaluate whether the presence or absence of GERD symptoms at baseline prior to proton pump inhibitor therapy will independently associate with improvement in any of the other outcomes measured
Measurements will include Juniper Asthma Control Questionnaire visits 2 and 5 Juniper Asthma Quality of Life Questionnaire visits 2 - 5 GSAS gastroesophageal reflux instrument visit 2 visit 5 the occurrence of adverse events change in FVC FEF25-75 MIF50 MEF50 peak expiratory flow rate FEV1 reversibility and the physical exam
Additional measurements will include methacholine challenge and eosinophilia in induced sputum specimens Induced sputum will be offered to all patients though it is anticipated that only approximately 50 will agree to this procedure
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