Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2026-02-04 @ 8:25 PM
Study NCT ID:
NCT00977366
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2009-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neurophysiology of Cough Reflex Hypersensitivity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003371', 'term': 'Cough'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D000148', 'term': 'Acids, Noncarboxylic'}, {'id': 'D000143', 'term': 'Acids'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-17', 'studyFirstSubmitDate': '2009-09-14', 'studyFirstSubmitQcDate': '2009-09-14', 'lastUpdatePostDateStruct': {'date': '2013-06-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of oesophageal acid infusion on cough reflex sensitivity in chronic cough patients compared to healthy controls.', 'timeFrame': 'baseline, immediatley after infusion, 90 minutes post infusion, 180 minutes post infusion, 24 hours after baseline', 'description': 'Outcome measures include; cough reflex sensitivity, pain threshold measures, 24 hour objective cough rate'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cough', 'Healthy Controls']}, 'descriptionModule': {'briefSummary': 'Central sensitisation is an increase in the excitability of nerves within the central nervous system, which can lead to heightened sensitivity to certain stimuli. This process is involved in some chronic pain conditions e.g. migraines and non-cardiac chest pain. Recent work by our group suggests central sensitisation may be an important mechanism leading to chronic cough.\n\nThe main questions in this study include:\n\n1. Can the investigators induce temporary central sensitisation of the cough reflex in healthy volunteers for testing of new medications?\n2. Can the investigators demonstrate exaggerated sensitisation in patients with chronic cough (indicating these patients are already centrally sensitised)?\n\nIn animal studies, acid infusion into the gullet (oesophagus) is able to induce central sensitisation of the cough reflex. Acid infusion into the oesophagus has also been shown to induce central sensitisation in human healthy volunteers, increasing the sensitivity to pain on the front of the chest but this study did not test the the cough reflex. Using human participants, the investigators plan to test whether acid infusion into the oesophagus increases the sensitivity of the cough reflex in healthy volunteers and also patients complaining of chronic cough.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHealthy volunteers inclusion:\n\n* Over 18 years\n* Measurable cough reflex sensitivity - required as is the primary end-point\n* No current or past history of chronic cough or chronic respiratory disease\n\nChronic Cough Patients inclusion:\n\n* Over 18 years\n* Chronic persistent cough (\\> 8 weeks) despite investigation and/or treatment trials for cough variant asthma/post-nasal drip and gastro-oesophageal reflux\n* Normal chest radiograph - primary respiratory cause for cough excluded\n* Normal lung function - primary respiratory cause for cough excluded Measurable cough reflex sensitivity - required as primary end-point\n\nExclusion Criteria:\n\n* Recent upper respiratory tract infection (\\<4 weeks) - this can lead to increased sensitivity of the cough reflex which resolves as the infection settles\n* Pregnancy/breast-feeding - unknown effects of oesophageal acid infusion\n* Current smokers or ex-smokers with \\< 6 month abstinence or history \\> 20 pack years - smoking can alter the sensitivity of the cough reflex\n* Opiate or ACE inhibitor use or centrally acting medication - can alter the cough reflex sensitivity\n* Symptomatic gastro-oesophageal reflux, post-nasal drip or asthma (chronic cough cohort may have been treated for these in the past but cough did not resolve) - these conditions are known to cause cough and alter cough reflex sensitivity\n* Significant ongoing chronic respiratory/cardiovascular/gastro-intestinal/haematological/ neurological/psychiatric illness. We are aiming to recruit healthy volunteers and chronic cough patients who are otherwise healthy'}, 'identificationModule': {'nctId': 'NCT00977366', 'acronym': 'NOTCH', 'briefTitle': 'Neurophysiology of Cough Reflex Hypersensitivity', 'organization': {'class': 'OTHER', 'fullName': 'University of Manchester'}, 'officialTitle': 'Pilot Study Investigating Central Sensitisation of the Cough Reflex in Subjects With Chronic Cough and Healthy Volunteers', 'orgStudyIdInfo': {'id': '09/H1004/21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hydrochloric acid infusion', 'interventionNames': ['Other: Hydrochloric acid (0.15 molar)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline', 'interventionNames': ['Other: Saline']}], 'interventions': [{'name': 'Hydrochloric acid (0.15 molar)', 'type': 'OTHER', 'description': 'Hydrochloric acid (0.15 molar) will be infused in to the lower oesophagus through a distal infusion port located at the tip of an oesophageal stimulation catheter.', 'armGroupLabels': ['Hydrochloric acid infusion']}, {'name': 'Saline', 'type': 'OTHER', 'description': 'Normal saline will be infused in to the lower oesophagus through a distal infusion port located at the tip of an oesophageal stimulation catheter.', 'armGroupLabels': ['Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M23 9LT', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'University Hospital of South Manchester', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Ashley Woodcock, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Manchester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Manchester', 'class': 'OTHER'}, 'collaborators': [{'name': 'JP Moulton Charitable Foundation', 'class': 'OTHER'}, {'name': 'Medical Research Council', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MRC Clinician Scientist/Honorary Respiratory Consultant', 'investigatorFullName': 'Jacky Smith', 'investigatorAffiliation': 'University of Manchester'}}}}