Cough Reflex Sensitivity and Bronchial Hyper-responsiveness
Overview
Tab Title Description
Study type
InterventionalDescribes 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.
Study IDs
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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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 the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Kenneth DeVault, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available