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

NCT ID: NCT00234117

Last Updated: 2011-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31

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.

Conditions

Bronchial Asthma; Gastroesophageal Reflux

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Rabeprazole

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PriCara, Unit of Ortho-McNeil, Inc.

INDUSTRY

Sponsor Role: collaborator

Ponce Gastroenterology Research

OTHER

Sponsor Role: lead

Responsible Party

Ponce Gastroenterology

Principal Investigators

Alvaro Reymunde, MD

Role: PRINCIPAL_INVESTIGATOR

Ponce Gastroenterology Research

Locations

Ponce Gastroentrology Research

Ponce, , Puerto Rico

Countries

Puerto Rico

Other Identifiers

RAB-EMR-4037

Identifier Type: -

Identifier Source: org_study_id