Pilot Studies Evaluating Cough Reflex Sensitivity and Bronchial Hyper-responsiveness: The Road to Cough and Wheeze in Patients With Gastroesophageal Reflux.


Jacksonville, Fla.

Trial status:

Open for Enrollment

Why is this study being done?

The aim of this study is to provide pilot data on the possible gastrointestinal predictors of respiratory hyper-responsiveness and how these relate to the clinical sub-types of GERD and visceral acid hypersensitivity.

Who is eligible to participate?

Inclusion Criteria: - symptomatic reflux(ie one symptom at least one day a week, with at least 'moderate' severity) - no evidence of esophagitis - non-smokers Exclusion Criteria: - previous gastrointestinal surgery (excluding minor surgeries, such as cholecystectomy, appendectomy - active peptic ulcer disease - Zollinger Ellison Syndrome - Barrett's esophagus - eosinophilic esophagitis - cardiac disease - diabetes or neurological deficit - use of tricyclics - selective serotonin reuptake inhibitors - narcotics or benzodiazepines - current use of medications that may affect symptoms of perception,lower esophageal sphincter basal pressure, acid clearance time or acid suppression - antibiotics within 60 days - Nursing mothers will be excluded - allergies to citrus - asthma - chronic lung disease - heart attack or stroke within the last three months - hypersensitivity to methacholine products - know aortic aneurysm - uncontrolled hypertension (defined as systolic pressure greater than 200 or diastolic greater than 100) - reduced pulmonary function test (forced expiratory volume in one second [FEV1] or the FEV1 to forced vital capacity [FEV1/FVC] ratio of less that 70% of predicted value) - None of the controls will have any GERD symptoms or ever used antireflux treatment.

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