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

This study has been completed.
Sponsor:
Collaborator:
PriCara, Unit of Ortho-McNeil, Inc.
Information provided by:
Ponce Gastroenterology Research
ClinicalTrials.gov Identifier:
NCT00234117
First received: October 5, 2005
Last updated: July 20, 2011
Last verified: October 2005

October 5, 2005
July 20, 2011
July 2005
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Efficacy of rabeprazole treatment will be described using the proportion of the subjects with complete acid suppression at week 12
Same as current
Complete list of historical versions of study NCT00234117 on ClinicalTrials.gov Archive Site
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Improvement in Bronchial Asthma in Patients With Extraesophageal Reflux After Acid Suppression
Overall Assessment of Improvement in Bronchial Asthma Patients With Extraesophageal Reflux After Effective Acid Suppression

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.

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.

Interventional
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Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Bronchial Asthma
  • Gastroesophageal Reflux
Drug: Rabeprazole
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Puerto Rico
 
NCT00234117
RAB-EMR-4037
Not Provided
Dr. Nilda Santiago, Ponce Gastroenterology
Ponce Gastroenterology Research
PriCara, Unit of Ortho-McNeil, Inc.
Principal Investigator: Alvaro Reymunde, MD Ponce Gastroenterology Research
Ponce Gastroenterology Research
October 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP