Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2025-12-28 @ 2:06 PM
Study NCT ID:
NCT03851393
Status:
COMPLETED
Last Update Posted:
2019-07-15
First Post:
2014-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of Peptest™ for the Detection of Reflux in Cough
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003371', 'term': 'Cough'}, {'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-11', 'studyFirstSubmitDate': '2014-05-15', 'studyFirstSubmitQcDate': '2019-02-20', 'lastUpdatePostDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'level of pepsin in saliva following a citric acid cough challenge', 'timeFrame': '3 months', 'description': 'detecting the levels of pepsin in saliva following Citric acid induced cough'}], 'secondaryOutcomes': [{'measure': 'normal range of saliva pepsin', 'timeFrame': '3 months', 'description': 'record normal range of saliva pepsin following citric acid cough challenge'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cough', 'Reflux', 'Pepsin', 'Peptest'], 'conditions': ['Cough']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://thorax.bmj.com/content/68/Suppl_3/A19.2', 'label': 'Publication Link'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nThis study aims to identify if cough induced by inhaled citric acid in healthy adult volunteers leads to detectable pepsin in expectorated saliva.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A negative score for airway reflux (HARQ score \\<13).\n* Provision of informed consent.\n\nExclusion Criteria:\n\n* Participants with a positive score for airway reflux (HARQ score \\>13).\n* Chronic respiratory disease.\n* Acute gastro-respiratory illness at the time of the study.\n* Participants who will be physically unable to undergo sputum collection or cough induction.\n* Those who are unwilling to undergo cough challenge and induction of cough.\n* Smoking or consumption of food, caffeinated or carbonated beverages for 30 minutes prior to sample collection.'}, 'identificationModule': {'nctId': 'NCT03851393', 'briefTitle': 'Validation of Peptest™ for the Detection of Reflux in Cough', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hull University Teaching Hospitals NHS Trust'}, 'officialTitle': 'Validation of Peptest™ for the Detection of Reflux in Cough; Induction of Cough in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'Acadmed130514'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Peptest™ analysis of saliva pepsin', 'description': 'Induction of cough with inhaled citric acid and measurement of saliva pepsin following citric acid cough challenge using the peptest lateral device', 'interventionNames': ['Other: Induction of cough with inhaled citric acid', 'Procedure: Peptest™ analysis of saliva pepsin', 'Diagnostic Test: Peptest™']}], 'interventions': [{'name': 'Induction of cough with inhaled citric acid', 'type': 'OTHER', 'description': 'perform artificially induced cough by inhalation of citric acid at various strengths', 'armGroupLabels': ['Peptest™ analysis of saliva pepsin']}, {'name': 'Peptest™ analysis of saliva pepsin', 'type': 'PROCEDURE', 'description': 'collect patient saliva for analysis of pepsin levels', 'armGroupLabels': ['Peptest™ analysis of saliva pepsin']}, {'name': 'Peptest™', 'type': 'DIAGNOSTIC_TEST', 'description': 'The Peptest™ lateral flow device', 'armGroupLabels': ['Peptest™ analysis of saliva pepsin']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'HU16 5JQ', 'city': 'Cottingham', 'state': 'Yorkshire', 'country': 'United Kingdom', 'facility': 'Hull Clinical Trials Unit, Respiratory academic department', 'geoPoint': {'lat': 52.50243, 'lon': -0.7554}}], 'overallOfficials': [{'name': 'Alyn Morice, MD, FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hull University Teaching Hospitals NHS Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hull University Teaching Hospitals NHS Trust', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}