Cough Reflex Sensitivity and Bronchial Hyper-responsiveness
This study is currently recruiting participants.
Verified January 2013 by Mayo Clinic
Sponsor:
Mayo Clinic
Collaborator:
University of Manchester, UK
Information provided by (Responsible Party):
Lesley A. Houghton, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01777867
First received: January 24, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
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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
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, UK
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: | January 24, 2013 |
| 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 May 21, 2013