Improvement in Bronchial Asthma in Patients With Extraesophageal Reflux After Acid Suppression

July 20, 2011 updated by: Ponce Gastroenterology Research

Overall Assessment of Improvement in Bronchial Asthma Patients With Extraesophageal Reflux After Effective Acid Suppression

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Ponce, Puerto Rico, 00717
        • Ponce Gastroentrology Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Efficacy of rabeprazole treatment will be described using the proportion of the subjects with complete acid suppression at week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ponce Gastroenterology Research

Collaborators

PriCara, Unit of Ortho-McNeil, Inc.

Investigators

  • Principal Investigator: Alvaro Reymunde, MD, Ponce Gastroenterology Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Study Registration Dates

First Submitted

October 5, 2005

First Submitted That Met QC Criteria

October 5, 2005

First Posted (Estimate)

October 6, 2005

Study Record Updates

Last Update Posted (Estimate)

July 22, 2011

Last Update Submitted That Met QC Criteria

July 20, 2011

Last Verified

October 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAB-EMR-4037

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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