Validation of Peptest™ for the Detection of Reflux in Cough

Sponsor
Hull University Teaching Hospitals NHS Trust (Other)
Overall Status
Completed
CT.gov ID
NCT03851393
Collaborator
(none)
30
1
1
2
15

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Induction of cough with inhaled citric acid
  • Procedure: Peptest™ analysis of saliva pepsin
  • Diagnostic Test: Peptest™
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Validation of Peptest™ for the Detection of Reflux in Cough; Induction of Cough in Healthy Volunteers
Study Start Date :
Aug 1, 2014
Actual Primary Completion Date :
Oct 1, 2014
Actual Study Completion Date :
Oct 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. level of pepsin in saliva following a citric acid cough challenge [3 months]

    detecting the levels of pepsin in saliva following Citric acid induced cough

Secondary Outcome Measures

  1. normal range of saliva pepsin [3 months]

    record normal range of saliva pepsin following citric acid cough challenge

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hull Clinical Trials Unit, Respiratory academic department Cottingham Yorkshire United Kingdom HU16 5JQ

Sponsors and Collaborators

  • Hull University Teaching Hospitals NHS Trust

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Hull University Teaching Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT03851393
Other Study ID Numbers:
  • Acadmed130514
First Posted:
Feb 22, 2019
Last Update Posted:
Jul 15, 2019
Last Verified:
Jul 1, 2019
Keywords provided by Hull University Teaching Hospitals NHS Trust
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 15, 2019