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临床试验/NCT00234117
NCT00234117已完成不适用

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

Ponce Gastroenterology Research2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2005年7月1日最近更新:
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相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Efficacy of rabeprazole treatment will be described using the proportion of the subjects with complete acid suppression at week 12

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Moderate Persistent or moderate severe bronchial asthma as determined by the study pulmonologist
  • Gastroesophageal Reflux disease

排除标准

  • History of hypersensitivity to rabeprazole or its metabolites

结局指标

主要结局

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

次要结局

未报告次要终点

研究者

发起方
Ponce Gastroenterology Research
申办方类型
Other

研究点 (2)

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