Cough Reflex Sensitivity and Bronchial Hyper-responsiveness


  • Study type

  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Jacksonville, Florida: 11-006873
    NCT ID: NCT01777867
    Sponsor Protocol Number: 11-006873

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status

Jacksonville, Fla.

Mayo Clinic principal investigator

Kenneth DeVault, M.D.

Closed for enrollment


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