Pilot Studies Evaluating Cough Reflex Sensitivity and Bronchial Hyper-responsiveness: The Road to Cough and Wheeze in Patients With Gastroesophageal Reflux.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gastroesophageal Reflux Disease
- Sponsor
- Mayo Clinic
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Change in cough reflex sensitivity (CRS)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Kenneth R. DeVault, M.D.
Professor, College of Medicine
Mayo Clinic
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change in cough reflex sensitivity (CRS)
Time Frame: baseline, approximately 4 weeks