Cough Reflex Sensitivity and Bronchial Hyper-responsiveness

Completed

Conditions studied: Gastroesophageal Reflux Disease, Chronic Cough, Broncho-hyperreactivity

In brief

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 gastroesophageal reflux disease (GERD) and visceral acid hypersensitivity.

Key facts

Study ID

NCT01777867

Run by

Mayo Clinic

People needed

24

Starts

2012-12-01

Expected to finish

2016-02-01

Last updated by the study team

2017-02-17

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• symptomatic reflux (i.e., one symptom at least one day a week, with at least 'moderate' severity)
• no evidence of esophagitis
• non-smokers

You may not qualify if…

• 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 (FVC) ratio (FEV1/FVC) of less that 70% of predicted value)
• None of the controls will have any GERD symptoms or ever used antireflux treatment.

Where it is running

• Mayo Clinic Florida — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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