Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2026-02-20 @ 6:05 PM
Study NCT ID:
NCT01854268
Status:
COMPLETED
Last Update Posted:
2022-02-09
First Post:
2013-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Respiratory Kinematics During Voluntary and Reflex Cough in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D002211', 'term': 'Capsaicin'}], 'ancestors': [{'id': 'D053284', 'term': 'Polyunsaturated Alkamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005229', 'term': 'Fatty Acids, Monounsaturated'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aessman@ufl.edu', 'phone': '352-273-3711', 'title': 'Alexandra E. Brandimore, M.A. CCC/SLP', 'organization': 'University of Florida'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'All study participants were recruited during one month.', 'description': 'There were no adverse events associated with this protocol.', 'eventGroups': [{'id': 'EG000', 'title': 'Healthy Adults Who Receive Capsaicin', 'description': 'Single treatment consisting of healthy adults.\n\nHealthy adults received capsaicin: Participants were seated in a comfortable chair and fitted with cotton elastic bands designed to measure changes in chest wall and abdominal movement during cough. The participant breathed through a facemask attached to a pneumotachograph, nebulizer, and dosimeter. The participant received 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants had a minute in between each presentation and water will be available at all times.', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Lung Volume Initiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Adults Who Receive Capsaicin', 'description': 'Single treatment consisting of healthy adults.\n\nHealthy adults who receive capsaicin: Participants will be seated in a comfortable chair and fitted with cotton elastic bands designed to measure changes in chest wall and abdominal movement during cough. The participant will hold a facemask attached to a pneumotachograph, nebulized, and dosimeter. The participant will receive 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants will have a minute in between each presentation and water will be available at all times.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.3', 'spread': '5.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 hour', 'description': 'Respiratory kinematic measure: lung volume initiation (LVI) Lung volume initiation is a measure of the volume of air in the lungs prior to a respiratory task.', 'unitOfMeasure': '% Vital Capacity, relative to EEL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '25 healthy young volunteers participated in this study. The average age was 23 years and none had a history of respiratory or neurological disease.'}, {'type': 'SECONDARY', 'title': 'Peak Expiratory Airflow Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Adults Who Receive Capsaicin', 'description': 'Single treatment consisting of healthy adults.\n\nHealthy adults who receive capsaicin: Participants will be seated in a comfortable chair and fitted with cotton elastic bands designed to measure changes in chest wall and abdominal movement during cough. The participant will hold a facemask attached to a pneumotachograph, nebulized, and dosimeter. The participant will receive 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants will have a minute in between each presentation and water will be available at all times.'}], 'classes': [{'title': 'PEFR - Voluntary Cough', 'categories': [{'measurements': [{'value': '6.058', 'spread': '.56', 'groupId': 'OG000'}]}]}, {'title': 'PEFR - Reflex Cough', 'categories': [{'measurements': [{'value': '5.437', 'spread': '.43', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 hour', 'description': 'Airflow measures: Peak expiratory airflow rate Peak expiratory flow rate is a measure of the velocity of air expelled from the respiratory apparatus during cough. Measured in liters/second.', 'unitOfMeasure': 'Liters/second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Urge-to-cough', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Adults Who Receive Capsaicin', 'description': 'Single treatment consisting of healthy adults.\n\nHealthy adults who receive capsaicin: Participants will be seated in a comfortable chair and fitted with cotton elastic bands designed to measure changes in chest wall and abdominal movement during cough. The participant will hold a facemask attached to a pneumotachograph, nebulized, and dosimeter. The participant will receive 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants will have a minute in between each presentation and water will be available at all times.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'spread': '.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1 hour', 'description': 'Urge-to-cough: A measure of respiratory sensation that rates the perceived magnitude of the need to cough on a Borg scale (0=no urge-to-cough; 10=maximal urge-to-cough).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Healthy Adults Who Receive Capsaicin', 'description': 'Single treatment consisting of healthy adults.\n\nHealthy adults received capsaicin: Participants were seated in a comfortable chair and fitted with cotton elastic bands designed to measure changes in the chest wall and abdomen during cough. Participants breathed through a facemask attached to a pneumotachograph, nebulizer, and dosimeter. Participants received 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants rested for a minute in between each presentation and water was available at all times.\n\nPulmonary function testing: Investigators placed cotton elastic bands around the chest and abdomen so that measures of chest wall and abdominal movements could be measured. Forced vital capacity and rest breathing was completed.\n\nNebulized water (Fog): The investigators provided nebulized water (FOG) through the facemask for up to a minute three times. A minute break was allotted between each presentation.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Healthy Adults Who Receive Capsaicin', 'description': 'Single treatment consisting of healthy adults.\n\nHealthy adults who receive capsaicin: Participants were seated in a comfortable chair and fitted with cotton elastic bands designed to measure changes in chest wall and abdominal movement during cough. The participant breathed through a facemask attached to a pneumotachograph, nebulizer, and dosimeter. The participant received 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants had a minute in between each presentation and water was available at all times.\n\nPulmonary function testing: Investigators will first place cotton elastic bands around your chest and abdomen so that measures of chest wall and abdominal movements can be measured. Forced vital capacity and rest breathing maneuvers were completed.\n\nNebulized water (Fog): The investigators will provide you with nebulized water (FOG) through the facemask for up to a minute three times. A minute break in between each presentation.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '23.3', 'spread': '3.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Lung volume initiation', 'classes': [{'categories': [{'measurements': [{'value': '23.3', 'spread': '5.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Lung volume initiation (LVI), termination (LVT), and excursion (LVE) measurements during voluntary and reflex cough: mean percent vital capacity difference relative to end-expiratory level (EEL). Significant lung volume differences between reflex and voluntary cough', 'unitOfMeasure': '%vital capacity, relative to EEL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Peak expiratory airflow rate', 'classes': [{'categories': [{'measurements': [{'value': '6.058', 'spread': '.56', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Liters/second', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Urge-to-cough', 'classes': [{'categories': [{'measurements': [{'value': '7', 'spread': '.32', 'groupId': 'BG000'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All participants were evaluated one time. Therefore baseline evaluations were the only measures completed.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-03', 'studyFirstSubmitDate': '2013-05-10', 'resultsFirstSubmitDate': '2014-12-10', 'studyFirstSubmitQcDate': '2013-05-10', 'lastUpdatePostDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-02-17', 'studyFirstPostDateStruct': {'date': '2013-05-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lung Volume Initiation', 'timeFrame': '1 hour', 'description': 'Respiratory kinematic measure: lung volume initiation (LVI) Lung volume initiation is a measure of the volume of air in the lungs prior to a respiratory task.'}], 'secondaryOutcomes': [{'measure': 'Peak Expiratory Airflow Rate', 'timeFrame': '1 hour', 'description': 'Airflow measures: Peak expiratory airflow rate Peak expiratory flow rate is a measure of the velocity of air expelled from the respiratory apparatus during cough. Measured in liters/second.'}, {'measure': 'Urge-to-cough', 'timeFrame': '1 hour', 'description': 'Urge-to-cough: A measure of respiratory sensation that rates the perceived magnitude of the need to cough on a Borg scale (0=no urge-to-cough; 10=maximal urge-to-cough).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cough'], 'conditions': ['Cough']}, 'descriptionModule': {'briefSummary': 'Cough is a defensive behavior that involves three stages. A large inspiratory phase, a compression phase where the vocal folds close and subglottal pressure is developed, and an expiratory phase. Cough serves to protect the upper and lower airways from material such as liquids, solids, or saliva, that have been aspirated. There are two types of cough: voluntary and reflex cough. Voluntary cough involves a cough to command. Reflex cough is a cough that is generated secondary to a stimulus in or near the airway. There has been some research regarding the differences between voluntary and reflex cough. However, no research has described the differences in airflow or movement pattern (kinematics) between the two types of cough. This study seeks to determine the respiratory kinematics and airflow differences between voluntary and reflex cough in healthy participants.', 'detailedDescription': 'As a participant, completion of this study will require the following:\n\nInvestigators will first place cotton elastic bands around your chest and abdomen so that measures of chest wall and abdominal movements can be measured. Then, tests of your breathing made from pulmonary function testing will be completed.\n\nInvestigators will then have you complete a maximum inspiration followed by a maximum expiration three times.\n\nInvestigators will ask you to produce a voluntary cough three times into a facemask which is attached to a computer.\n\nThen the investigators will provide you with nebulized water (FOG) through the facemask for up to a minute three times. You will have a minute break in between each presentation.\n\nFinally, the investigators will provide you with a nebulized dose of Capsaicin, which is derived from hot peppers, through the same facemask used in all of the above tasks. You will receive three doses of capsaicin and be provided with water at any time during the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy adults between the ages of 18-80 years.\n* Ability to provide informed consent.\n\nExclusion Criteria:\n\n* No history of smoking within the last 5 years as this reduces the sensitivity to capsaicin\n* No history of neurological disease (i.e. Parkinson's disease, stroke, traumatic brain injury, etc.)\n* No known allergy to capsaicin\n* No history of respiratory disease (i.e. asthma, chronic obstructive pulmonary disease, or respiratory infection within the last 5 weeks.)"}, 'identificationModule': {'nctId': 'NCT01854268', 'briefTitle': 'Respiratory Kinematics During Voluntary and Reflex Cough in Healthy Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Respiratory Kinematics During Voluntary and Reflex Cough in Healthy Adults', 'orgStudyIdInfo': {'id': '32-2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy adults who receive capsaicin', 'description': 'Single treatment consisting of healthy adults.', 'interventionNames': ['Drug: Healthy adults who receive capsaicin']}], 'interventions': [{'name': 'Healthy adults who receive capsaicin', 'type': 'DRUG', 'otherNames': ['capsaicin'], 'description': 'Participants will be seated in a comfortable chair and fitted with cotton elastic bands designed to measure changes in chest wall and abdominal movement during cough. The participant will hold a facemask attached to a pneumotachograph, nebulized, and dosimeter. The participant will receive 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants will have a minute in between each presentation and water will be available at all times.', 'armGroupLabels': ['Healthy adults who receive capsaicin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32611', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida, Dauer Hall', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Alexandra E. Brandimore, M.A.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}