Improvement in Bronchial Asthma in Patients With Extraesophageal Reflux After Acid Suppression
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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 |
- 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 |
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 |
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| Puerto Rico | |
| Ponce Gastroentrology Research | |
| Ponce, Puerto Rico, 00717 | |
| 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 Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Ulcer Agents Gastrointestinal Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013