Improvement in Bronchial Asthma in Patients With Extraesophageal Reflux After Acid Suppression
Primary Purpose
Bronchial Asthma, Gastroesophageal Reflux
Status
Completed
Phase
Not Applicable
Locations
Puerto Rico
Study Type
Interventional
Intervention
Rabeprazole
Sponsored by
About this trial
This is an interventional treatment trial for Bronchial Asthma
Eligibility Criteria
Inclusion Criteria: Moderate Persistent or moderate severe bronchial asthma as determined by the study pulmonologist Gastroesophageal Reflux disease Exclusion Criteria: History of hypersensitivity to rabeprazole or its metabolites
Sites / Locations
- Ponce Gastroentrology Research
Outcomes
Primary Outcome Measures
Efficacy of rabeprazole treatment will be described using the proportion of the subjects with complete acid suppression at week 12
Secondary Outcome Measures
Full Information
NCT ID
NCT00234117
First Posted
October 5, 2005
Last Updated
July 20, 2011
Sponsor
Ponce Gastroenterology Research
Collaborators
PriCara, Unit of Ortho-McNeil, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00234117
Brief Title
Improvement in Bronchial Asthma in Patients With Extraesophageal Reflux After Acid Suppression
Official Title
Overall Assessment of Improvement in Bronchial Asthma Patients With Extraesophageal Reflux After Effective Acid Suppression
Study Type
Interventional
2. Study Status
Record Verification Date
October 2005
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Ponce Gastroenterology Research
Collaborators
PriCara, Unit of Ortho-McNeil, Inc.
4. Oversight
5. Study Description
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 measure),as well as symptomatic response.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchial Asthma, Gastroesophageal Reflux
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Rabeprazole
Primary Outcome Measure Information:
Title
Efficacy of rabeprazole treatment will be described using the proportion of the subjects with complete acid suppression at week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Moderate Persistent or moderate severe bronchial asthma as determined by the study pulmonologist
Gastroesophageal Reflux disease
Exclusion Criteria:
History of hypersensitivity to rabeprazole or its metabolites
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alvaro Reymunde, MD
Organizational Affiliation
Ponce Gastroenterology Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ponce Gastroentrology Research
City
Ponce
ZIP/Postal Code
00717
Country
Puerto Rico
12. IPD Sharing Statement
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Improvement in Bronchial Asthma in Patients With Extraesophageal Reflux After Acid Suppression
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