NCT03851393

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Hull University Teaching Hospitals NHS Trust · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cough

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-08-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2019-02-22
• Last updated: 2019-07-15

Locations

1 site across 1 country: United Kingdom