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

Gastroesophageal Reflux Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00234117
• Other study ID #: RAB-EMR-4037
• Status: Completed
• Phase: N/A
• First received: October 5, 2005
• Last updated: July 20, 2011
• Start date: July 2005

Study information

• Verified date: October 2005
• Source: Ponce Gastroenterology Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Asthma
• Bronchial Asthma
• Gastroesophageal Reflux

Intervention

Drug:
• Rabeprazole

Locations

Country	Name	City	State
Puerto Rico	Ponce Gastroentrology Research	Ponce

Sponsors (2)

Lead Sponsor	Collaborator
Ponce Gastroenterology Research	PriCara, Unit of Ortho-McNeil, Inc.

Country where clinical trial is conducted

Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of rabeprazole treatment will be described using the proportion of the subjects with complete acid suppression at week 12