Cough Reflex Sensitivity and Bronchial Hyper-responsiveness

NCT01777867 | Completed

• 1 other identifier: 11-006873
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroesophageal Reflux Disease; Chronic Cough; Broncho-hyperreactivity

Outcome Measures

Primary Outcomes (1)

• Change in cough reflex sensitivity (CRS)

  baseline, approximately 4 weeks

Study Arms (3)

Healthy Volunteers

Subjects in this arm were healthy volunteers. Subjects underwent both Cough Reflex Sensitivity and the Methacholine Challenge procedures.

Procedure: Cough Reflex Sensitivity; Procedure: Methacholine Challenge

Non-erosive reflux disease with reflux

Subjects enrolled in this arm had non-erosive reflux disease with reflux (heartburn) for at least 6 of the preceding 12 months. Subjects underwent both Cough Reflex Sensitivity and the Methacholine Challenge procedures.

Procedure: Cough Reflex Sensitivity; Procedure: Methacholine Challenge

Non-erosive reflux disease without reflux

Subjects enrolled in this arm had non-erosive reflux disease with normal levels of reflux (heartburn). Subjects underwent both Cough Reflex Sensitivity and the Methacholine Challenge procedures.

Procedure: Cough Reflex Sensitivity; Procedure: Methacholine Challenge

Interventions

Cough Reflex Sensitivity PROCEDURE

Subjects inhaled increasing concentrations of citric acid, which induces coughing in a dose-dependent, reproducible matter. Following each inhalation, the number of coughs in the subsequent 15 seconds was counted and recorded. The challenge was terminated once the citric acid induced 5 or more coughs and the logarithmic (base 10) concentration provoking 5 coughs was recorded.

Healthy Volunteers; Non-erosive reflux disease with reflux; Non-erosive reflux disease without reflux

Methacholine Challenge PROCEDURE

A baseline spirometry was used to assess how well the participant's lungs work by measuring how much air was inhale, how much was exhale and how quickly the participant exhaled. If this was normal, the subject inhaled slowly and deeply the methacholine test solution from a nebulizer and was told to hold their breath for 5 seconds. This was repeated until 5 inhalations were performed in no more than two minutes.

Healthy Volunteers; Non-erosive reflux disease with reflux; Non-erosive reflux disease without reflux

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

This study will recruit participants into three groups ages 18-60 years: 12 reflux patients with non-erosive disease (NERD) with abnormal levels of acid reflux, 12 NERD patients with normal levels of reflux and 12 healthy volunteers.

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

Sponsors & Collaborators

• Mayo Clinic: lead
• University of Manchester: collaborator

Study Sites (1)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Chronic Cough

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Cough; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kenneth R. DeVault, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, College of Medicine

Study Record Dates

• First Submitted: January 24, 2013
• First Posted: January 29, 2013
• Study Start: December 1, 2012
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: February 17, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)