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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03851393
Enrollment
30
Registered
2019-02-22
Start date
2014-08-31
Completion date
2014-10-31
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cough

Keywords

Cough, Reflux, Pepsin, Peptest

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.

Interventions

OTHERInduction of cough with inhaled citric acid

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

PROCEDUREPeptest™ analysis of saliva pepsin

collect patient saliva for analysis of pepsin levels

DIAGNOSTIC_TESTPeptest™

The Peptest™ lateral flow device

Sponsors

Hull University Teaching Hospitals NHS Trust
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
level of pepsin in saliva following a citric acid cough challenge3 monthsdetecting the levels of pepsin in saliva following Citric acid induced cough

Secondary

MeasureTime frameDescription
normal range of saliva pepsin3 monthsrecord normal range of saliva pepsin following citric acid cough challenge

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026