Esophageal Motility in Reflux Induced Cough

NCT02492126 | Completed

• 1 other identifier: 15-002020
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

To determine whether contraction abnormalities in the esophagus plays a role in gastroesophageal reflux induced cough, and thus cough severity in patients with chronic cough.

Conditions

Cough

Keywords

Chronic Cough; Gastroesophageal Reflux; Esophageal Motility; Cough Sensitivity

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects with reflux related cough

  24 hrs

Study Arms (1)

Chronic Cough

Subjects with chronic cough will undergo cough reflex sensitivity testing to citric acid. The dose, starting at 0.03 mol/L citric acid will be administered as single breath inhalations using flow-limited calibrated pots and a dosimeter with 3 placebo inhalations of normal saline randomly interspersed. Following each inhalation, the number of coughs in the subsequent 15 seconds will be counted and recorded. The challenge will be terminated once the citric acid has induced 5 or more coughs.

Other: Citric Acid

Interventions

Citric Acid OTHER

Subjects will undergo cough reflex sensitivity testing to citric acid.

Chronic Cough

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Chronic cough patients

You may qualify if:

• Adult patients (ages 18-75 years old)
• Cough for more than 8 weeks
• Additional clinical evaluation of cough including a complete pulmonary function test with methacholine challenge and a high resolution CT scan of the chest.
• Ability to understand the purpose and nature of the study
• Willingness to participate and provide consent form

You may not qualify if:

• Actively smoke in the preceding 6 months.
• Recent respiratory tract infection (\<4 weeks).
• Drink above the recommended safe alcohol limit (21 units per week).
• History of respiratory or gastrointestinal malignancies.
• Previous gastrointestinal surgery (excluding minor surgeries, such as cholecystectomy, appendectomy).
• Subjects with established and significant cardiac, pulmonary, or neurological disorders as deemed by the clinician or study personnel
• Use of angiotensin converting enzyme inhibitors
• Use of H2 blockers or proton pump inhibitors in the seven days prior to reflux testing (impedance/pH), or inability to withhold such medications for the duration of the study
• Women of childbearing potential, using adequate birth control. Adequate birth control includes: (i) hormonal methods, such as birth control pills, patches, injections, vaginal ring, or implants; (ii) barrier methods (such as, a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm); (iii) intrauterine device (IUD); or (iv) abstinence (no sex). Adequate birth control must be maintained for the duration of the study. Women not using adequate birth control will be excluded from the study, as funding for the pregnancy tests was not included in the small grant awarded for this study.
• Nursing mothers will be excluded.
• Persons with allergies to citrus will be excluded.
• Inability to understand the purpose and nature of the study
• Unwillingness to participate and provide consent form

Sponsors & Collaborators

• Mayo Clinic: lead
• University of Manchester: collaborator

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Cough; Chronic Cough; Gastroesophageal Reflux

Interventions

Citric Acid

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Kenneth DeVault, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 2, 2015
• First Posted: July 8, 2015
• Study Start: January 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: October 30, 2020

Record last verified: 2020-10

Locations

US (1)