Validation of Peptest™ for the Detection of Reflux in Cough

Validation of Peptest™ for the Detection of Reflux in Cough; Induction of Cough in Healthy Volunteers

Chronic cough is a common presenting problem which has a significant impact on quality of life. Gastro-oesophageal reflux (GOR) is a common cause of chronic cough and reflux of stomach contents into the airways has been implicated in the pathogenesis of a number of respiratory diseases. Clinical history in patients with suspected reflux can aid in the diagnosis but traditional investigations for GOR including 24hr oesophageal pH monitoring or endoscopy are not reliable diagnostic tools since the reflux may be non acidic.

The detection of pepsin in the sputum, saliva or bronchial biopsy has been found to be an accurate marker of reflux into the airways. Pepsin is solely produced by parietal cells in the stomach. The presence of pepsin in the upper airways therefore indicates reflux. Studies have demonstrated that pepsin was frequently found in laryngeal biopsies and sputum of patients with signs and symptoms of airways reflux and that Nissen fundoplication resulted in a decrease in pepsin detection alongside an improvement in symptoms. The Peptest™ lateral flow device has been shown to be effective in the detection of pepsin in sputum and saliva of patients with chronic cough and gastro-oesophageal reflux. The investigators have detected pepsin in expectorated saliva during episodes of cough, apparently supporting a diagnosis of airways reflux. Critics, however, have suggested that the act coughing itself is responsible for the reflux.

This study aims to identify if cough induced by inhaled citric acid in healthy adult volunteers leads to detectable pepsin in expectorated saliva.

Study Overview

• Status: Completed
• Conditions: Cough
• Intervention / Treatment: Other: Induction of cough with inhaled citric acid; Procedure: Peptest™ analysis of saliva pepsin; Diagnostic test: Peptest™

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Yorkshire
    • Cottingham, Yorkshire, United Kingdom, HU16 5JQ
      • Hull Clinical Trials Unit, Respiratory academic department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• A negative score for airway reflux (HARQ score <13).
• Provision of informed consent.

Exclusion Criteria:

• Participants with a positive score for airway reflux (HARQ score >13).
• Chronic respiratory disease.
• Acute gastro-respiratory illness at the time of the study.
• Participants who will be physically unable to undergo sputum collection or cough induction.
• Those who are unwilling to undergo cough challenge and induction of cough.
• Smoking or consumption of food, caffeinated or carbonated beverages for 30 minutes prior to sample collection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Peptest™ analysis of saliva pepsin; Induction of cough with inhaled citric acid and measurement of saliva pepsin following citric acid cough challenge using the peptest lateral device	Other: Induction of cough with inhaled citric acid; perform artificially induced cough by inhalation of citric acid at various strengths; Procedure: Peptest™ analysis of saliva pepsin; collect patient saliva for analysis of pepsin levels; Diagnostic test: Peptest™; The Peptest™ lateral flow device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
level of pepsin in saliva following a citric acid cough challenge	detecting the levels of pepsin in saliva following Citric acid induced cough	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
normal range of saliva pepsin	record normal range of saliva pepsin following citric acid cough challenge	3 months

Collaborators and Investigators

• Sponsor: Hull University Teaching Hospitals NHS Trust
• Investigators: Principal Investigator: Alyn Morice, MD, FRCP, Hull University Teaching Hospitals NHS Trust

Publications and helpful links

Helpful Links

• Publication Link

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: May 15, 2014
• First Submitted That Met QC Criteria: February 20, 2019
• First Posted (Actual): February 22, 2019

Study Record Updates

• Last Update Posted (Actual): July 15, 2019
• Last Update Submitted That Met QC Criteria: July 11, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Reflux; Cough; Pepsin; Peptest
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough; Molecular Mechanisms of Pharmacological Action; Anticoagulants; Chelating Agents; Sequestering Agents; Calcium Chelating Agents; Citric Acid; Sodium Citrate
• Other Study ID Numbers: Acadmed130514