Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2026-01-06 @ 12:19 PM
Study NCT ID:
NCT00677560
Status:
COMPLETED
Last Update Posted:
2021-12-20
First Post:
2008-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Natural History of Small Airways Physiology in Diseased and Healthy States
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D003550', 'term': 'Cystic Fibrosis'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System 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': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'h.kalsi@qmul.ac.uk', 'phone': '07872492181', 'title': 'Dr Harpal Singh Kalsi', 'organization': 'Queen Mary University of London'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Mild-moderate Asthma', 'description': 'Mild-moderate asthma recruited at baseline', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sever Asthma', 'description': 'Sever Asthma recruited at baseline', 'otherNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Normal Subjects', 'description': 'Normal subjects at baseline', 'otherNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Healthy Smokers', 'description': 'Healthy smokers at baseline', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'COPD (Gold Stage I - III)', 'description': 'COPD (Gold stage I - III) baseline', 'otherNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'FEV1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Mild-moderate Asthma', 'description': 'Asthmatics (mild, moderate and severe) were classified according to the Global Initiative for Asthma diagnostic criteria (GINA, 2009).'}, {'id': 'OG001', 'title': 'Severe Asthma', 'description': 'Asthmatics (mild, moderate and severe) were classified according to the Global Initiative for Asthma diagnostic criteria (GINA, 2009).'}, {'id': 'OG002', 'title': 'Normal Subjects', 'description': 'This group consisted of 29 never-smokers with no history of respiratory disease'}, {'id': 'OG003', 'title': 'Healthy Smokers', 'description': 'The healthy smoking group consisted of 20 current smokers with no history of respiratory disease'}, {'id': 'OG004', 'title': 'COPD (Gold Stage I-III)', 'description': 'COPD patients (stages I - III) were classified according to the Global Initiative for Chronic Obstructive Lung Disease guidelines (GOLD, 2011).'}], 'classes': [{'categories': [{'measurements': [{'value': '3.03', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '2.32', 'spread': '0.88', 'groupId': 'OG001'}, {'value': '3.18', 'spread': '0.79', 'groupId': 'OG002'}, {'value': '2.76', 'spread': '0.73', 'groupId': 'OG003'}, {'value': '1.67', 'spread': '0.44', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '120 minutes', 'description': 'Forced expiratory volume in one second', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Calv', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Mild-moderate Asthma', 'description': 'Asthmatics (mild, moderate and severe) were classified according to the Global Initiative for Asthma diagnostic criteria (GINA, 2009).'}, {'id': 'OG001', 'title': 'Severe Asthma', 'description': 'Asthmatics (mild, moderate and severe) were classified according to the Global Initiative for Asthma diagnostic criteria (GINA, 2009).'}, {'id': 'OG002', 'title': 'Normal Subjects', 'description': 'This group consisted of 29 never-smokers with no history of respiratory disease'}, {'id': 'OG003', 'title': 'Healthy Smokers', 'description': 'The healthy smoking group consisted of 20 current smokers with no history of respiratory disease'}, {'id': 'OG004', 'title': 'COPD (Gold Stage I - III)', 'description': 'COPD patients (stages I - III) were classified according to the Global Initiative for Chronic Obstructive Lung Disease guidelines (GOLD, 2011).'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '3.2', 'groupId': 'OG001'}, {'value': '2.9', 'spread': '1.7', 'groupId': 'OG002'}, {'value': '4.6', 'spread': '2.9', 'groupId': 'OG003'}, {'value': '3.7', 'spread': '2.6', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '120 minutes', 'description': 'Nitric oxide arising from the alveolar compartment.', 'unitOfMeasure': 'ppb', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'AX', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Mild-moderate Asthma', 'description': 'Asthmatics (mild, moderate and severe) were classified according to the Global Initiative for Asthma diagnostic criteria (GINA, 2009).'}, {'id': 'OG001', 'title': 'Severe Asthma', 'description': 'Asthmatics (mild, moderate and severe) were classified according to the Global Initiative for Asthma diagnostic criteria (GINA, 2009).'}, {'id': 'OG002', 'title': 'Normal Subjects', 'description': 'This group consisted of 29 never-smokers with no history of respiratory disease.'}, {'id': 'OG003', 'title': 'Healthy Smokers', 'description': 'The healthy smoking group consisted of 20 current smokers with no history of respiratory disease'}, {'id': 'OG004', 'title': 'COPD (Gold Stage I - III)', 'description': 'COPD patients (stages I - III) were classified according to the Global Initiative for Chronic Obstructive Lung Disease guidelines (GOLD, 2011).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.03', 'spread': '1.05', 'groupId': 'OG000'}, {'value': '1.88', 'spread': '2.20', 'groupId': 'OG001'}, {'value': '0.55', 'spread': '0.57', 'groupId': 'OG002'}, {'value': '0.82', 'spread': '0.93', 'groupId': 'OG003'}, {'value': '2.48', 'spread': '2.12', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '120 minutes', 'description': 'Reactance area for whole-breath', 'unitOfMeasure': 'kPa/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'R5 EX', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Mild-moderate Asthma', 'description': 'Asthmatics (mild, moderate and severe) were classified according to the Global Initiative for Asthma diagnostic criteria (GINA, 2009).'}, {'id': 'OG001', 'title': 'Severe Asthma', 'description': 'Asthmatics (mild, moderate and severe) were classified according to the Global Initiative for Asthma diagnostic criteria (GINA, 2009).'}, {'id': 'OG002', 'title': 'Normal Subjects', 'description': 'This group consisted of 29 never-smokers with no history of respiratory disease'}, {'id': 'OG003', 'title': 'Healthy Smokers', 'description': 'The healthy smoking group consisted of 20 current smokers with no history of respiratory disease'}, {'id': 'OG004', 'title': 'COPD (Gold Stage I - III)', 'description': '1357'}], 'classes': [{'categories': [{'measurements': [{'value': '0.50', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '0.60', 'spread': '0.21', 'groupId': 'OG001'}, {'value': '0.45', 'spread': '0.16', 'groupId': 'OG002'}, {'value': '0.50', 'spread': '0.25', 'groupId': 'OG003'}, {'value': '0.66', 'spread': '0.24', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '120 minutes', 'description': 'Resistance measured at 5 hertz during expiration', 'unitOfMeasure': 'kPa/L/s', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "J'aw", 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Mild-moderate Asthma', 'description': 'Asthmatics (mild, moderate and severe) were classified according to the Global Initiative for Asthma diagnostic criteria (GINA, 2009).'}, {'id': 'OG001', 'title': 'Severe Asthma', 'description': 'Asthmatics (mild, moderate and severe) were classified according to the Global Initiative for Asthma diagnostic criteria (GINA, 2009).'}, {'id': 'OG002', 'title': 'Normal Subjects', 'description': 'This group consisted of 29 never-smokers with no history of respiratory disease'}, {'id': 'OG003', 'title': 'Healthy Smokers', 'description': 'The healthy smoking group consisted of 20 current smokers with no history of respiratory disease'}, {'id': 'OG004', 'title': 'COPD (Gold Stage I - III)', 'description': 'COPD patients (stages I - III) were classified according to the Global Initiative for Chronic Obstructive Lung Disease guidelines (GOLD, 2011).'}], 'classes': [{'categories': [{'measurements': [{'value': '138.5', 'spread': '85', 'groupId': 'OG000'}, {'value': '77.2', 'spread': '62.4', 'groupId': 'OG001'}, {'value': '76.2', 'spread': '46.1', 'groupId': 'OG002'}, {'value': '35.4', 'spread': '21.2', 'groupId': 'OG003'}, {'value': '60.7', 'spread': '47.6', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '120 minutes', 'description': 'Bronchial nitric oxide flux', 'unitOfMeasure': 'nl/s', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sacin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Mild-moderate Asthma', 'description': 'Asthmatics (mild, moderate and severe) were classified according to the Global Initiative for Asthma diagnostic criteria (GINA, 2009).'}, {'id': 'OG001', 'title': 'Severe Asthma', 'description': 'Asthmatics (mild, moderate and severe) were classified according to the Global Initiative for Asthma diagnostic criteria (GINA, 2009).'}, {'id': 'OG002', 'title': 'Normal Subjects', 'description': 'This group consisted of 29 never-smokers with no history of respiratory disease'}, {'id': 'OG003', 'title': 'Healthy Smokers', 'description': 'The healthy smoking group consisted of 20 current smokers with no history of respiratory disease'}, {'id': 'OG004', 'title': 'COPD (Gold Stage I-III)', 'description': 'COPD patients (stages I - III) were classified according to the Global Initiative for Chronic Obstructive Lung Disease guidelines (GOLD, 2011).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.122', 'spread': '0.094', 'groupId': 'OG000'}, {'value': '0.214', 'spread': '0.194', 'groupId': 'OG001'}, {'value': '0.089', 'spread': '0.051', 'groupId': 'OG002'}, {'value': '0.150', 'spread': '0.084', 'groupId': 'OG003'}, {'value': '0.346', 'spread': '0.139', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '120 minutes', 'description': 'Ventilation heterogeneity within the acinar airways', 'unitOfMeasure': '/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Scond', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Subjects', 'description': 'This group consisted of 29 never-smokers with no history of respiratory disease'}, {'id': 'OG001', 'title': 'Healthy Smokers', 'description': 'The healthy smoking group consisted of 20 current smokers with no history of respiratory disease'}, {'id': 'OG002', 'title': 'Mild-moderate Asthma', 'description': 'Asthmatics (mild, moderate and severe) were classified according to the Global Initiative for Asthma diagnostic criteria (GINA, 2009).'}, {'id': 'OG003', 'title': 'Severe Asthma', 'description': 'Asthmatics (mild, moderate and severe) were classified according to the Global Initiative for Asthma diagnostic criteria (GINA, 2009).'}, {'id': 'OG004', 'title': 'COPD (Gold Stage I - III)', 'description': 'COPD patients (stages I - III) were classified according to the Global Initiative for Chronic Obstructive Lung Disease guidelines (GOLD, 2011).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.041', 'spread': '0.016', 'groupId': 'OG000'}, {'value': '0.068', 'spread': '0.027', 'groupId': 'OG001'}, {'value': '0.045', 'spread': '0.015', 'groupId': 'OG002'}, {'value': '0.057', 'spread': '0.026', 'groupId': 'OG003'}, {'value': '0.057', 'spread': '0.020', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '120 minutes', 'description': 'Ventilation heterogeneity within the conducting airways', 'unitOfMeasure': '/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all subjects have results for this parameter which is why the total number of results will not equal the number of participants recruited.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mild-moderate Asthma', 'description': 'Asthmatics (mild, moderate and severe) were classified according to the Global Initiative for Asthma diagnostic criteria (GINA, 2009).'}, {'id': 'FG001', 'title': 'Severe Asthma', 'description': 'Asthmatics (mild, moderate and severe) were classified according to the Global Initiative for Asthma diagnostic criteria (GINA, 2009).'}, {'id': 'FG002', 'title': 'Normal Subjects', 'description': 'This group consisted of 29 never-smokers with no history of respiratory disease.'}, {'id': 'FG003', 'title': 'Healthy Smokers', 'description': 'Healthy smokers had no history of respiratory disease, and were all current smokers'}, {'id': 'FG004', 'title': 'COPD (Gold Stage I - III)', 'description': 'COPD patients (stages I - III) were classified according to the Global Initiative for Chronic Obstructive Lung Disease guidelines (GOLD, 2011).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '29'}, {'groupId': 'FG003', 'numSubjects': '20'}, {'groupId': 'FG004', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '17'}, {'groupId': 'FG004', 'numSubjects': '13'}]}]}], 'recruitmentDetails': 'This was a single centre cross-sectional and longitudinal study involving asthmatic and chronic obstructive pulmonary disease (COPD) patients and healthy volunteers (including smokers).\n\nSubjects were between the ages of 18-85 years old, were given a patient information sheet and provided their written informed consent. Subjects were interviewed at visit 1 and a medical history was documented.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '34', 'groupId': 'BG004'}, {'value': '126', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Normal Subjects', 'description': 'This group consisted of 29 never-smokers with no history of respiratory disease'}, {'id': 'BG001', 'title': 'Healthy Smokers', 'description': 'The healthy smoking group consisted of 20 current smokers with no history of respiratory disease'}, {'id': 'BG002', 'title': 'Mild-moderate Asthma', 'description': 'Asthmatics (mild, moderate and severe) were classified according to the Global Initiative for Asthma diagnostic criteria (GINA, 2009).'}, {'id': 'BG003', 'title': 'Severe Asthma', 'description': 'Asthmatics (mild, moderate and severe) were classified according to the Global Initiative for Asthma diagnostic criteria (GINA, 2009).'}, {'id': 'BG004', 'title': 'COPD (Gold Stage I - III)', 'description': 'COPD patients (stages I - III) were classified according to the Global Initiative for Chronic Obstructive Lung Disease guidelines (GOLD, 2011).'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50', 'spread': '15', 'groupId': 'BG000'}, {'value': '55', 'spread': '10', 'groupId': 'BG001'}, {'value': '41', 'spread': '15', 'groupId': 'BG002'}, {'value': '50', 'spread': '14', 'groupId': 'BG003'}, {'value': '66', 'spread': '7', 'groupId': 'BG004'}, {'value': '54', 'spread': '15', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '58', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '68', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '168.2', 'spread': '10.7', 'groupId': 'BG000'}, {'value': '167.2', 'spread': '11.3', 'groupId': 'BG001'}, {'value': '174.3', 'spread': '10.1', 'groupId': 'BG002'}, {'value': '168.7', 'spread': '8.5', 'groupId': 'BG003'}, {'value': '164.4', 'spread': '8.5', 'groupId': 'BG004'}, {'value': '168.1', 'spread': '10.1', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '73.05', 'spread': '17.99', 'groupId': 'BG000'}, {'value': '66.95', 'spread': '15.55', 'groupId': 'BG001'}, {'value': '76.30', 'spread': '17.19', 'groupId': 'BG002'}, {'value': '76.00', 'spread': '13.18', 'groupId': 'BG003'}, {'value': '69.75', 'spread': '14.04', 'groupId': 'BG004'}, {'value': '72.2', 'spread': '15.8', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '25.63', 'spread': '4.80', 'groupId': 'BG000'}, {'value': '23.90', 'spread': '4.82', 'groupId': 'BG001'}, {'value': '24.90', 'spread': '4.04', 'groupId': 'BG002'}, {'value': '26.89', 'spread': '5.64', 'groupId': 'BG003'}, {'value': '25.76', 'spread': '4.57', 'groupId': 'BG004'}, {'value': '25.5', 'spread': '4.8', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Smoking status', 'classes': [{'title': 'Current smokers', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '30', 'groupId': 'BG005'}]}]}, {'title': 'Ex-smokers', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}, {'value': '26', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2013-07-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-03', 'studyFirstSubmitDate': '2008-05-12', 'resultsFirstSubmitDate': '2020-12-18', 'studyFirstSubmitQcDate': '2008-05-13', 'lastUpdatePostDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-11-03', 'studyFirstPostDateStruct': {'date': '2008-05-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-07-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FEV1', 'timeFrame': '120 minutes', 'description': 'Forced expiratory volume in one second'}], 'secondaryOutcomes': [{'measure': 'Calv', 'timeFrame': '120 minutes', 'description': 'Nitric oxide arising from the alveolar compartment.'}, {'measure': 'AX', 'timeFrame': '120 minutes', 'description': 'Reactance area for whole-breath'}, {'measure': 'R5 EX', 'timeFrame': '120 minutes', 'description': 'Resistance measured at 5 hertz during expiration'}, {'measure': "J'aw", 'timeFrame': '120 minutes', 'description': 'Bronchial nitric oxide flux'}, {'measure': 'Sacin', 'timeFrame': '120 minutes', 'description': 'Ventilation heterogeneity within the acinar airways'}, {'measure': 'Scond', 'timeFrame': '120 minutes', 'description': 'Ventilation heterogeneity within the conducting airways'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['resistance', 'reactance', 'inflammation', 'lung function', 'respiratory function'], 'conditions': ['Asthma', 'COPD', 'Interstitial Lung Disease', 'Cystic Fibrosis', 'Patients Requiring Lung Transplant']}, 'descriptionModule': {'briefSummary': 'Spirometry is a useful clinical tool for the assessment and monitoring of lung disease, however, it does not provide information on peripheral airways resistance. On the contrary, impulse oscillometry (IOS) may provide information not only on airway resistance (Rrs) but also on the elastic properties of the lung (Xrs). In addition, multiple breath nitrogen washout (MBNW) utilizes the exhalation of nitrogen gas from the airways to determine changes in lung ventilation and derive small airways indices (that tells us about small airways calibre). This method, like IOS, allows a precise assessment of small airways function.\n\nEven though patients with asthma may show some reduction of the caliber of the small airways these changes are more a feature of patients with COPD. The study team hypothesize that IOS and MBNW measurements may detect these differences and provide different resistance profiles for asthma and COPD. Furthermore, the study team would like to investigate the relationship between airway inflammation and small airway disease by measuring exhaled nitric oxide (NO) at multiple exhalation flow rates. This technique allows the partitioning of NO produced in the central airways from that generated more peripherally in the lung, providing valuable information on the activity of inflammation in different parts of the respiratory system. The study team hope that the combined use of IOS, MBNW and NO will identify a possible correlation between inflammation and small airway dysfunction.', 'detailedDescription': 'Background\n\nThe main objective of this study is to measure the damage of the small airways in lung disease exploring the "silent zone" with methods that have not been used before together in the same patients. Furthermore, because this is a 4 year longitudinal study, the study team will investigate the time related changes of small airway function in lung disease and normal healthy subjects.\n\nThe study will also investigate the relationship between small airway resistance and inflammation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients will be recruited from outpatient clinics', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male or female, aged between 18-85 years;\n* volunteers who are able to give written informed consent Patients meeting the diagnostic criteria for asthma, COPD, ILD, CF, chronic cough.\n\nExclusion Criteria:\n\n* upper respiratory tract infection within the previous 28 days\n* any history or evidence of renal, cardiovascular, gastrointestinal or hepatic disease\n* any history and evidence of neuropsychiatric disease\n* treatment with antibiotics within 4 weeks prior to the study\n* alcohol, drug abuse or any other condition associated with poor compliance\n* breast feeding\n* pregnancy\n* are unable to provide written informed consent'}, 'identificationModule': {'nctId': 'NCT00677560', 'briefTitle': 'The Natural History of Small Airways Physiology in Diseased and Healthy States', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'Impulse Oscillometry and Airway Inflammation in Asthma and Chronic Obstructive Pulmonary Disease and Airways Physiology in Other Lung Conditions and Healthy Lungs', 'orgStudyIdInfo': {'id': '08/H0709/2'}}, 'armsInterventionsModule': {'armGroups': [{'label': '3', 'description': 'Mild-moderate asthma.\n\nWithin the asthma group, there were two sub-groups; mild-moderate asthma and severe asthma distinguished using the Global Initiative for Asthma (GINA) guidelines (GINA, 2009).'}, {'label': '4', 'description': 'Severe Asthma\n\nWithin the asthma group, there were two sub-groups; mild-moderate asthma and severe asthma distinguished using the Global Initiative for Asthma (GINA) guidelines (GINA, 2009).'}, {'label': '1', 'description': 'Normal subjects\n\nNormal subjects were a group made up of healthy subjects, with normal lung function, non-smokers at the time of the screening.'}, {'label': '2', 'description': 'Healthy smokers\n\nHealthy smokers were comprised of people who were current smokers and had normal lung function at the time of screening.'}, {'label': '5', 'description': 'COPD (Gold stage I - III)\n\nThe COPD group included stage I to III patients, classified according to severity of airflow limitation (post bronchodilator FEV1), from the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (GOLD, 2011).'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SW3 6LY', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Airway Disease Section, National Heart and Lung Institute, Imperial College', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Paolo Paredi, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Airway Disease Section, National Heart and Lung Institute, Imperial College, London'}, {'name': 'Omar A Usmani, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Airway Disease Section, National Heart and Lung Institute, Imperial College, London'}, {'name': 'Peter J Barnes, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Airway Disease Section, National Heart and Lung Institute, Imperial College, London'}, {'name': 'Neil Pride, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Airway Disease Section, National Heart and Lung Institute, Imperial College, London'}, {'name': 'Michael Goldman, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Airway Disease Section, National Heart and Lung Institute, Imperial College, London'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}