Esophageal Motility in Reflux Induced Cough | NCT02492126

Studies
Esophageal Motility in Reflux Induced Cough

NCT02492126

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Oct 30, 2020Actual

Enrollment

87Actual

Phase

Not provided

Conditions

Cough

Interventions

Citric Acid

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Jun 2017Actual

Completion Date

Jun 2017Actual

First Submitted Date

Jul 2, 2015

First Submission Date that Met QC Criteria

Jul 2, 2015

First Posted Date

Jul 8, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 28, 2020

Last Update Posted Date

Oct 30, 2020Actual

Name	Class
University of Manchester	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

87Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Citric Acid	Other	Subjects will undergo cough reflex sensitivity testing to citric acid.	Chronic Cough

Measure	Description	Time Frame
Percentage of subjects with reflux related cough		24 hrs

Eligibility Module

Eligibility Criteria

Inclusion criteria:

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

Exclusion criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Chronic cough patients

Sampling Method

Probability Sample

ID	Term
D003371	Cough
D000096822	Chronic Cough
D005764	Gastroesophageal Reflux

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms

ID	Term
D002951	Citrates
D014233	Tricarboxylic Acids
D000144	Acids, Acyclic
D002264	Carboxylic Acids