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

This study has been completed.
Sponsor:
Collaborator:
PriCara, Unit of Ortho-McNeil, Inc.
Information provided by:
Ponce Gastroenterology Research
ClinicalTrials.gov Identifier:
NCT00234117
First received: October 5, 2005
Last updated: July 20, 2011
Last verified: October 2005
  Purpose

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.


Condition Intervention
Bronchial Asthma
Gastroesophageal Reflux
Drug: Rabeprazole

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Overall Assessment of Improvement in Bronchial Asthma Patients With Extraesophageal Reflux After Effective Acid Suppression

Resource links provided by NLM:


Further study details as provided by Ponce Gastroenterology Research:

Primary Outcome Measures:
  • Efficacy of rabeprazole treatment will be described using the proportion of the subjects with complete acid suppression at week 12

Estimated Enrollment: 40
Study Start Date: July 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00234117

Locations
Puerto Rico
Ponce Gastroentrology Research
Ponce, Puerto Rico, 00717
Sponsors and Collaborators
Ponce Gastroenterology Research
PriCara, Unit of Ortho-McNeil, Inc.
Investigators
Principal Investigator: Alvaro Reymunde, MD Ponce Gastroenterology Research
  More Information

No publications provided

Responsible Party: Dr. Nilda Santiago, Ponce Gastroenterology
ClinicalTrials.gov Identifier: NCT00234117     History of Changes
Other Study ID Numbers: RAB-EMR-4037
Study First Received: October 5, 2005
Last Updated: July 20, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Gastroesophageal Reflux
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Rabeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014