Bronchial Asthma, Gastroesophageal Reflux
Conditions
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.
Interventions
DRUGRabeprazole
Sponsors
PriCara, Unit of Ortho-McNeil, Inc.
Ponce Gastroenterology Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of rabeprazole treatment will be described using the proportion of the subjects with complete acid suppression at week 12 | — |
Countries
Puerto Rico
Outcome results
None listed