Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00234117
Status:
COMPLETED
Last Update Posted:
2011-07-22
First Post:
2005-10-05
Brief Title:
Improvement in Bronchial Asthma in Patients With Extraesophageal Reflux After Acid Suppression
Sponsor:
Ponce Gastroenterology Research
Organization:
Ponce Gastroenterology Research
Study Overview
Official Title:
Overall Assessment of Improvement in Bronchial Asthma Patients With Extraesophageal Reflux After Effective Acid Suppression
Status:
COMPLETED
Status Verified Date:
2005-10
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 purpose of this study is to determine if 20mg BID of Rabeprazole is effective in controlling GERD in patients with concomitant bronchial asthma and to assess improvement in asthma after reflux control
Detailed Description:
Gastroesophageal Reflux Disease has been considered as having a role in the course of asthma as shown by the improvement of symptoms with adequate acid suppression therapy It is important to consider and establish the presence of GERD in patients with asthma specially those who fail to respond to conventional asthma management It is believed that two mechanisms may play a role in the association between Bronchial Asthma and GERD most commonly microaspiration of acid causing bronchoconstriction the second being increased vagal tone
Establishing an adequate and timely diagnosis and confirming or excluding a relationship between the two entities in asthmatic patients is the first step towards effective patient management The next important consideration is establishing the correct acid suppression therapy and monitoring response to therapy with objective testing such as Pulmonary Function Testing PFT and esophageal pH testing Since there is not a real normal or physiologic reflux measure for patients with extresophageal manifestations as seen in patients with classic reflux where a total time of exposure to acid pH 4 less than 5 is considered normal in these patients it will be necessary to establish a more strict pH control than in those with classic GERD Achieving complete acid control in this population is expected to require higher doses of medication than those used in patients with classic reflux and no extraesophageal manifestations Thus we have developed this study in which we will assess the response to 20 mg BID dosing of Rabeprazole measured by pH monitoring and then follow improvement in Pulmonary Function Testing objective measureas well as symptomatic response
Establishing an adequate and timely diagnosis and confirming or excluding a relationship between the two entities in asthmatic patients is the first step towards effective patient management The next important consideration is establishing the correct acid suppression therapy and monitoring response to therapy with objective testing such as Pulmonary Function Testing PFT and esophageal pH testing Since there is not a real normal or physiologic reflux measure for patients with extresophageal manifestations as seen in patients with classic reflux where a total time of exposure to acid pH 4 less than 5 is considered normal in these patients it will be necessary to establish a more strict pH control than in those with classic GERD Achieving complete acid control in this population is expected to require higher doses of medication than those used in patients with classic reflux and no extraesophageal manifestations Thus we have developed this study in which we will assess the response to 20 mg BID dosing of Rabeprazole measured by pH monitoring and then follow improvement in Pulmonary Function Testing objective measureas well as symptomatic response
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