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

Condition(s) targeted: Bronchial Asthma; Gastroesophageal Reflux

Intervention: Rabeprazole (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Ponce Gastroenterology Research

Official(s) and/or principal investigator(s):
Alvaro Reymunde, MD, Principal Investigator, Affiliation: Ponce Gastroenterology Research

Overall contact:
Alvaro Reymunde, MD, Phone: 787-259-8323

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.

Official title: Overall Assessment of Improvement in Bronchial Asthma Patients With Extraesophageal Reflux After Effective Acid Suppression

Study design: Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Alvaro Reymunde, MD, Phone: 787-259-8323

Ponce Gastroentrology Research, Ponce 00717, Puerto Rico; Recruiting
Nilda Santiago, MD, Phone: 787-259-8323
Maria Mendez, RN, Phone: 787-259-8323
Alvaro Reymunde, MD, Principal Investigator
Nilda Santiago, MD, Sub-Investigator

Starting date: July 2005
Last updated: October 5, 2005