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Sponsors and Collaborators: |
Ponce Gastroenterology Research PriCara, Unit of Ortho-McNeil, Inc. |
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Information provided by: | Ponce Gastroenterology Research |
ClinicalTrials.gov Identifier: | NCT00234117 |
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 |
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Bronchial Asthma Gastroesophageal Reflux |
Drug: Rabeprazole |
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 |
Estimated Enrollment: | 40 |
Study Start Date: | July 2005 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Alvaro Reymunde, MD | 787-259-8323 |
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 |
Principal Investigator: | Alvaro Reymunde, MD | Ponce Gastroenterology Research |
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 |
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 |
Molecular Mechanisms of Pharmacological Action Immune System Diseases Bronchial Diseases Therapeutic Uses |
Anti-Ulcer Agents Gastrointestinal Agents Enzyme Inhibitors Pharmacologic Actions |