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Improvement in Bronchial Asthma in Patients With Extraesophageal Reflux After Acid Suppression
This study is currently recruiting participants.
Verified by Ponce Gastroenterology Research, October 2005
Sponsors and Collaborators: Ponce Gastroenterology Research
PriCara, Unit of Ortho-McNeil, Inc.
Information provided by: Ponce Gastroenterology Research
ClinicalTrials.gov Identifier: NCT00234117
  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

MedlinePlus related topics: Asthma GERD
Drug Information available for: E 3810
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: Overall Assessment of Improvement in Bronchial Asthma Patients With Extraesophageal Reflux After Effective Acid Suppression

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

Contacts
Contact: Alvaro Reymunde, MD 787-259-8323

Locations
Puerto Rico
Ponce Gastroentrology Research Recruiting
Ponce, Puerto Rico, 00717
Contact: Nilda Santiago, MD     787-259-8323        
Contact: Maria Mendez, RN     787-259-8323        
Principal Investigator: Alvaro Reymunde, MD            
Sub-Investigator: Nilda Santiago, MD            
Sponsors and Collaborators
Ponce Gastroenterology Research
PriCara, Unit of Ortho-McNeil, Inc.
Investigators
Principal Investigator: Alvaro Reymunde, MD Ponce Gastroenterology Research
  More Information

Study ID Numbers: RAB-EMR-4037
Study First Received: October 5, 2005
Last Updated: October 5, 2005
ClinicalTrials.gov Identifier: NCT00234117  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Esophageal disorder
Gastrointestinal Diseases
Asthma
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Lung Diseases, Obstructive
Hypersensitivity
Digestive System Diseases
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Esophageal Diseases
Rabeprazole
Respiratory Hypersensitivity

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Bronchial Diseases
Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009