Cough Reflex Sensitivity and Bronchial Hyper-responsiveness

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Mayo Clinic
Sponsor:
Collaborator:
University of Manchester
Information provided by (Responsible Party):
Lesley A. Houghton, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01777867
First received: January 24, 2013
Last updated: June 9, 2014
Last verified: June 2014
  Purpose

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.


Condition
Gastroesophageal Reflux Disease
Chronic Cough
Broncho-hyperreactivity

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Pilot Studies Evaluating Cough Reflex Sensitivity and Bronchial Hyper-responsiveness: The Road to Cough and Wheeze in Patients With Gastroesophageal Reflux.

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Prevent respiratory consequences of reflux disease. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: December 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
healthy volunteers
non-erosive reflux disease with reflux
non-erosive reflux disease without reflux

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01777867

Locations
United States, Florida
Mayo Clinic Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Kellie Ruday, BS, RRT    904-953-2255      
Principal Investigator: Lesley A Houghton, Ph. D.         
Sponsors and Collaborators
Mayo Clinic
University of Manchester
  More Information

No publications provided

Responsible Party: Lesley A. Houghton, Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01777867     History of Changes
Other Study ID Numbers: 11-006873
Study First Received: January 24, 2013
Last Updated: June 9, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cough
Gastroesophageal Reflux
Bronchial Hyperreactivity
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Bronchial Diseases

ClinicalTrials.gov processed this record on July 24, 2014