Cough Reflex Sensitivity and Bronchial Hyper-responsiveness



Status:Completed
Conditions:Gastroesophageal Reflux Disease , Infectious Disease, Pulmonary
Therapuetic Areas:Gastroenterology, Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 60
Updated:2/18/2017
Start Date:December 2012
End Date:February 2016

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

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.

This study recruited participants into three groups: reflux patients with non-erosive
disease (NERD) with abnormal levels of acid reflux, NERD patients with normal levels of
reflux and healthy volunteers. Participants were assessed for cough reflex sensitivity (CRS)
to citric acid and bronchial-hyperresponsiveness (BHR) to methacholine challenge, both
before (baseline) and after esophageal acid infusion (HCl, 0.15M) or normal saline control
(8ml/min). The order of CRS and BHR was randomized, as was the order of the acid/saline
infusions.

Inclusion Criteria:

- symptomatic reflux (i.e., 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 (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.
We found this trial at
1
site
4500 San Pablo Rd S
Jacksonville, Florida 32224
(904) 953-2000
Principal Investigator: Lesley A Houghton, Ph. D.
Phone: 904-953-2255
Mayo Clinic Florida Thousands of people come to Mayo Clinic in Jacksonville, Fla., annually for...
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