Ignite Creation Date:
2025-12-24 @ 6:27 PM
Ignite Modification Date:
2025-12-28 @ 10:59 AM
Study NCT ID:
NCT01566968
Status:
COMPLETED
Last Update Posted:
2012-04-06
First Post:
2012-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Novel Endpoints in Cough Challenge Testing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D001249', 'term': 'Asthma'}, {'id': 'D000096822', 'term': 'Chronic Cough'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D003371', 'term': 'Cough'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-05', 'studyFirstSubmitDate': '2012-01-24', 'studyFirstSubmitQcDate': '2012-03-27', 'lastUpdatePostDateStruct': {'date': '2012-04-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD', 'Asthma', 'Healthy volunteers', 'Chronic cough', 'Smokers', 'Cough challenge', 'Cough challenge testing.'], 'conditions': ['Chronic Obstructive Pulmonary Disease', 'Asthma', 'Healthy', 'Chronic Cough', 'Smokers']}, 'descriptionModule': {'briefSummary': "The sensitivity of a person's cough reflex can be measured by getting them to breathe in (inhale) irritant chemicals. There are different methods by which subjects are asked to inhale these chemicals, either by taking one deep breath in, or by asking them to just continue to take a number of breaths. The purpose of this clinical research study is to see if the coughing responses are different in healthy people and people with respiratory problems that make them cough when they are given these chemicals in these two methods."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Selected from secondary care.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult subjects aged 18 and over.\n\nMeet criteria for subject groups as outlined below:\n\nHealthy volunteers:\n\n* Must be non smokers.\n* No history of respiratory disease.\n\nHealthy smokers:\n\n* Current smokers with at least 10 pack year history of smoking.\n* Spirometry within normal limits i.e. FEV1 \\> 80% predicted and FEV1/FVC ratio of \\> 75% predicted.\n\nAsthma:\n\n* Physician diagnosis of asthma\n* Stable asthma.\n* Airway hyperresponsiveness to methacoline; PC20\\< 16mg/ml.\n* Non smokers or ex-smokers with smoking history of less than 10 pack years.\n\nCOPD:\n\n* Physician diagnosis of COPD\n* Ex smokers with smoking history of at least 20 pack years\n* Spirometry demonstating evidence of airflow obstruction i.e. FEV1/FVC ratio of \\< 70%\n\nChronic cough:\n\n* History of dry cough for at least 8 weeks.\n* Normal chest x ray.\n* Non smokers or ex smokers of less than 10 pack years history of smoking.\n\nExclusion Criteria:\n\n* Symptoms of upper respiratory tract infection within the last 4 weeks.\n* Participation in another clinical trial of an investigational drug within 4 weeks.\n* Use of medication likely to alter cough reflex sensitivity i.e. ACE inhibitors, codeine phosphate, morphine sulphate.\n* Patients with severe respiratory disease i.e. FEV1 \\< 1.0 litre.\n* Use of steroid tablets in previous 2 months or taken more than 3 courses of steroid tablets in the preceding 12 months in subjects with asthma or COPD.\n* Change in asthma treatment in the preceding 6 weeks in asthma group\n* Significant medical co-morbidities likely to affect ability to participate in the trial or affect cough reflex sensitivity e.g. diabetes, stroke, Parkinson's disease, multiple sclerosis etc."}, 'identificationModule': {'nctId': 'NCT01566968', 'acronym': 'NEAT', 'briefTitle': 'Novel Endpoints in Cough Challenge Testing', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Manchester University NHS Foundation Trust'}, 'officialTitle': 'Novel Endpoints in Cough Challenge Testing.', 'orgStudyIdInfo': {'id': 'NEAT Version 2, 18/03/11'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy Volunteers', 'description': 'Adults between ages of 18-75 inclusive who have never smoked and have no history of any respiratory disease for which they are on regular treatment.', 'interventionNames': ['Other: Cough challenge test', 'Other: 24 hour ambulatory cough recording', 'Other: Cough quality of life questionnaire']}, {'label': 'Asthma', 'description': 'Adults between the ages on 18-75 inclusive who have a physician diagnosis of asthma and have no smoking history or minimal smoking history (less than 10 pack years or in other words less than 20 cigarettes per day for 10 years).', 'interventionNames': ['Other: Cough challenge test', 'Other: 24 hour ambulatory cough recording', 'Other: Cough quality of life questionnaire']}, {'label': 'COPD', 'description': 'Adults between the ages of 18-75 inclusive who have previously been smokers (at least 20 pack years) and have physician diagnosis and spirometry evidence of COPD.', 'interventionNames': ['Other: Cough challenge test', 'Other: 24 hour ambulatory cough recording', 'Other: Cough quality of life questionnaire']}, {'label': 'Healthy smokers', 'description': 'Adults between the ages of 18-75 inclusive who are currently smokers (at least 10 pack years history)but have no history of any respiratory disease and no evidence of COPD on spirometry.', 'interventionNames': ['Other: Cough challenge test', 'Other: 24 hour ambulatory cough recording', 'Other: Cough quality of life questionnaire']}, {'label': 'Chronic cough', 'description': 'Adults between ages of 18-75 inclusive who have history of dry cough for at least 8 weeks and have a normal chest x ray and no smoking history or minimal smoking history (less than 10 pack years).', 'interventionNames': ['Other: Cough challenge test', 'Other: 24 hour ambulatory cough recording', 'Other: Cough quality of life questionnaire']}], 'interventions': [{'name': 'Cough challenge test', 'type': 'OTHER', 'description': 'Cough challenge will be performed with Capsaicin, citric acid and prostaglandin E2.', 'armGroupLabels': ['Asthma', 'COPD', 'Chronic cough', 'Healthy Volunteers', 'Healthy smokers']}, {'name': '24 hour ambulatory cough recording', 'type': 'OTHER', 'description': 'Cough recording by using an ambulatory sound recording device.', 'armGroupLabels': ['Asthma', 'COPD', 'Chronic cough', 'Healthy Volunteers', 'Healthy smokers']}, {'name': 'Cough quality of life questionnaire', 'type': 'OTHER', 'description': "questionnaire designed to assess impact of cough on a person's life", 'armGroupLabels': ['Asthma', 'COPD', 'Chronic cough', 'Healthy Volunteers', 'Healthy smokers']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M23 9LT', 'city': 'Manchester', 'state': 'Greater Manchester', 'country': 'United Kingdom', 'facility': 'University Hospital of South Manchester', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Saifudin Khalid, MRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of South Manchester'}, {'name': 'Ashley Woodcock, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital of South Manchester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Manchester University NHS Foundation Trust', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}