Cough Reflex Sensitivity and Bronchial Hyper-responsiveness

Gastroesophageal Reflux Disease Clinical Trial

Official title:

Pilot Studies Evaluating Cough Reflex Sensitivity and Bronchial Hyper-responsiveness: The Road to Cough and Wheeze in Patients With Gastroesophageal Reflux.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01777867
• Other study ID #: 11-006873
• Status: Completed
• Phase: N/A
• First received: January 24, 2013
• Last updated: February 16, 2017
• Start date: December 2012
• Est. completion date: February 2016

Study information

• Verified date: February 2017
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This study recruited participants into three groups: reflux patients with non-erosive disease (NERD) with abnormal levels of acid reflux, NERD patients with normal levels of reflux and healthy volunteers. Participants were assessed for cough reflex sensitivity (CRS) to citric acid and bronchial-hyperresponsiveness (BHR) to methacholine challenge, both before (baseline) and after esophageal acid infusion (HCl, 0.15M) or normal saline control (8ml/min). The order of CRS and BHR was randomized, as was the order of the acid/saline infusions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• symptomatic reflux (i.e., 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 (FVC) ratio (FEV1/FVC) of less that 70% of predicted value)

• None of the controls will have any GERD symptoms or ever used antireflux treatment.

Related Conditions & MeSH terms

• Bronchial Hyperreactivity
• Broncho-hyperreactivity
• Chronic Cough
• Cough
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Procedure:
• Cough Reflex Sensitivity
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.
• Methacholine Challenge
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.

Locations

Country	Name	City	State
United States	Mayo Clinic Florida	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	University of Manchester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cough reflex sensitivity (CRS)		baseline, approximately 4 weeks