NCT03851393

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
4.4 years until next milestone

First Posted

Study publicly available on registry

February 22, 2019

Completed
Last Updated

July 15, 2019

Status Verified

July 1, 2019

Enrollment Period

2 months

First QC Date

May 15, 2014

Last Update Submit

July 11, 2019

Conditions

Cough

Keywords

CoughRefluxPepsinPeptest

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • normal range of saliva pepsin

    3 months

Study Arms (1)

Peptest™ analysis of saliva pepsin

EXPERIMENTAL

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 acidProcedure: Peptest™ analysis of saliva pepsinDiagnostic Test: Peptest™

Interventions

Induction of cough with inhaled citric acidOTHER

perform artificially induced cough by inhalation of citric acid at various strengths

Peptest™ analysis of saliva pepsin
Peptest™ analysis of saliva pepsinPROCEDURE

collect patient saliva for analysis of pepsin levels

Peptest™ analysis of saliva pepsin
Peptest™DIAGNOSTIC_TEST

The Peptest™ lateral flow device

Peptest™ analysis of saliva pepsin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hull Clinical Trials Unit, Respiratory academic department

Cottingham, Yorkshire, HU16 5JQ, United Kingdom

Location

Related Links

MeSH Terms

Conditions

CoughGastroesophageal Reflux

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsEsophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Alyn Morice, MD, FRCP

    Hull University Teaching Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2014

First Posted

February 22, 2019

Study Start

August 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

July 15, 2019

Record last verified: 2019-07

Locations

GB(1)