Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-02-25 @ 8:19 PM
Study NCT ID:
NCT02703467
Status:
COMPLETED
Last Update Posted:
2019-10-21
First Post:
2016-02-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Exhaled Hydrogen Sulphide as a Biomarker of Airways Disease in Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'f.chung@imperial.ac.uk', 'phone': '00442075947954', 'title': 'Professor Fan Chung', 'organization': 'Imperial College London'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Healthy', 'description': 'Healthy participants', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Mild-moderate', 'description': 'Mild-moderate asthma patients', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Severe', 'description': 'Severe asthma patients', 'otherNumAtRisk': 45, 'deathsNumAtRisk': 45, 'otherNumAffected': 0, 'seriousNumAtRisk': 45, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hydrogen Sulphide in Exhaled Breath', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy', 'description': 'Healthy participants'}, {'id': 'OG001', 'title': 'Mild-moderate', 'description': 'Mild-moderate asthma patients'}, {'id': 'OG002', 'title': 'Severe', 'description': 'Severe asthma patients'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '4.9', 'spread': '1.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'calculated', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'At baseline visit', 'description': 'Level of hydrogen sulphide in exhaled breath measured as parts per billion', 'unitOfMeasure': 'parts per billion', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'FEV1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Subjects', 'description': 'Healthy participants'}, {'id': 'OG001', 'title': 'Mild-moderate Asthma', 'description': 'Participants with Mild-moderate asthma'}, {'id': 'OG002', 'title': 'Severe Asthma', 'description': 'Participant with Severe asthma'}], 'classes': [{'categories': [{'measurements': [{'value': '98.9', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '92.0', 'spread': '11.1', 'groupId': 'OG001'}, {'value': '73.6', 'spread': '4.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline visit', 'description': 'Forced expiratory volume in one second as percent of predicted value (%)', 'unitOfMeasure': 'per cent of predicted value', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'FVC (Forced Vital Capacity)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy', 'description': 'Healthy participants'}, {'id': 'OG001', 'title': 'Mild-moderate', 'description': 'Mild-moderate asthma patients'}, {'id': 'OG002', 'title': 'Severe', 'description': 'Severe asthma patients'}], 'classes': [{'categories': [{'measurements': [{'value': '105.1', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '97.40', 'spread': '15.3', 'groupId': 'OG001'}, {'value': '88.22', 'spread': '3.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 4 visits which occur during the study duration, up to 1 year', 'description': 'Forced vital capacity as per cent of predicted', 'unitOfMeasure': 'per cent of predicted value (%)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Exhaled Nitric Oxide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Subjects', 'description': 'Healthy participants'}, {'id': 'OG001', 'title': 'Mild-moderate Asthma', 'description': 'Participants with Mild-moderate asthma'}, {'id': 'OG002', 'title': 'Severe Asthma', 'description': 'Participants with severe asthma'}], 'classes': [{'categories': [{'measurements': [{'value': '25.41', 'spread': '6.3', 'groupId': 'OG000'}, {'value': '39.42', 'spread': '13.6', 'groupId': 'OG001'}, {'value': '39.45', 'spread': '2.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 4 visits which occur during the study duration, up to 1 year', 'description': 'Levels of nitric oxide in exhaled breath in parts per billion', 'unitOfMeasure': 'parts per billion', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Blood Hydrogen Sulpide Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Subjects', 'description': 'Healthy participants'}, {'id': 'OG001', 'title': 'Mild-moderate Asthma', 'description': 'Participants with Mild-moderate asthma'}, {'id': 'OG002', 'title': 'Severe Asthma', 'description': 'Participant with Severe asthma'}], 'timeFrame': 'At 4 visits which occur during the study duration, up to 1 year', 'description': 'Hydrogen Sulpide level measurements from blood', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Healthy', 'description': 'Healthy participants'}, {'id': 'FG001', 'title': 'Mild-moderate', 'description': 'Mild-moderate asthma patients'}, {'id': 'FG002', 'title': 'Severe', 'description': 'Severe asthma patients'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '70', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Healthy', 'description': 'Healthy participants'}, {'id': 'BG001', 'title': 'Mild-moderate', 'description': 'Mild-moderate asthma patients'}, {'id': 'BG002', 'title': 'Severe', 'description': 'Severe asthma patients'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '70', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '51.1', 'spread': '3.5', 'groupId': 'BG000'}, {'value': '55.6', 'spread': '5.9', 'groupId': 'BG001'}, {'value': '55.9', 'spread': '11.5', 'groupId': 'BG002'}, {'value': '54.5', 'spread': '9.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '70', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '70', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '70', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2016-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-18', 'studyFirstSubmitDate': '2016-02-23', 'resultsFirstSubmitDate': '2019-09-18', 'studyFirstSubmitQcDate': '2016-03-03', 'lastUpdatePostDateStruct': {'date': '2019-10-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-18', 'studyFirstPostDateStruct': {'date': '2016-03-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hydrogen Sulphide in Exhaled Breath', 'timeFrame': 'At baseline visit', 'description': 'Level of hydrogen sulphide in exhaled breath measured as parts per billion'}], 'secondaryOutcomes': [{'measure': 'FEV1', 'timeFrame': 'At baseline visit', 'description': 'Forced expiratory volume in one second as percent of predicted value (%)'}, {'measure': 'FVC (Forced Vital Capacity)', 'timeFrame': 'At 4 visits which occur during the study duration, up to 1 year', 'description': 'Forced vital capacity as per cent of predicted'}, {'measure': 'Exhaled Nitric Oxide', 'timeFrame': 'At 4 visits which occur during the study duration, up to 1 year', 'description': 'Levels of nitric oxide in exhaled breath in parts per billion'}, {'measure': 'Blood Hydrogen Sulpide Level', 'timeFrame': 'At 4 visits which occur during the study duration, up to 1 year', 'description': 'Hydrogen Sulpide level measurements from blood'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exhaled hydrogen sulphide'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study will be to determine whether there is any role for measuring Hydrogen Sulphide (H2S) in the exhaled breath in terms of management of the patient with asthma.\n\nThe investigators will recruit patients with a range of severity of asthma and health volunteers. Levels of Hydrogen Sulphide will be measured in exhaled breath and blood. Also exhaled Nitric Oxide, Spirometry and asthma symptom scores will be measured at each study visit. Participants will attend either 2 or 4 separate visits.\n\nThe investigators will determine whether there is a relationship between exhaled Hydrogen Sulphide and asthma severity.', 'detailedDescription': 'Objectives:\n\n1. Perform a cross-sectional study in non-asthmatic subjects and asthmatic subjects of varying severities of the levels of Hydrogen Sulphide in exhaled breath in relation to the severity and control of asthma\n2. Compare the levels of exhaled Hydrogen Sulphide with exhaled Nitric Oxide.\n\nWe will recruit 30 health volunteers and 90 patients with a range of severity of asthma.\n\nParticpants will attend for either 2 or 4 visits. At these visits the following measurements will be taken:\n\n1. Exhaled Hydrogen Sulphide\n2. Serum Hydrogen Sulphide\n\n2\\. Exhaled Nitric Oxide 3. Spirometry 4. Asthma Symptom Score (ACQ)\n\nThe investigators will use a Hydrogen Sulphide UV fluorescent machine Model T101 (0-50 ppb to 0-20 ppm) (Cal-Bay Control Inc, USA) to measure directly on line exhaled breath Hydrogen Sulphide. This method has been used previously in normal people, but we will first determine whether there is an exhaled flow-dependence on the measurement of H2S levels. The investigators will use a hand-held Nitric Oxide machine (NO Breath) to measure Nitric Oxide in exhaled breath.\n\nSubjects must have asthma according to one or more of the following criteria documented in the last 12 months:\n\n1. Improvement in FEV1 (forced expiratory volume at one second) ≥ 12% and 200ml predicted after inhalation of 400 mcg salbutamol\n2. Airway hyper-responsiveness (PC20 \\<8mg/ml)\n3. Diurnal variation in PEF (peak expiratory flow): amplitude % mean of twice daily PEF \\> 8%\n4. Decrease in pre-bronchodilator FEV1 \\>12% and \\>200mls within 4 weeks after tapering treatment with one or more of the following drugs: inhaled corticosteroids, oral corticosteroids, long-acting beta-agonists, long-acting beta-agonists and short-acting beta-agonists.\n\nPLUS A history of wheeze occurring spontaneously or on exertion'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The investigators will recruit a cohort healthy subjects by advertisement within the Hospital and within the general public (by newspaper advertisement). The investigators will also recruit subjects with asthma from paients attending Asthma Clinics at the Royal Brompton and Harefiled NHS Trust.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll patients must be able to give informed consent. The definition of the severity of their asthma will be according to the GINA (Global Initiative for Asthma) guidelines dependent on the amount of therapy needed to control asthma. The investigators will also include at least 45 patients with severe asthma defined on the basis of: Uncontrolled asthma: three or more of the following features present in any week in the previous 4 weeks:\n\n* Daytime symptoms more than twice per week\n* Any limitation of activities\n* Nocturnal symptoms once or more per week\n* Need for reliever treatment more than twice per week\n* Pre bronchodilator FEV1 \\<80% predicted or personal best OR\n* Frequent severe exacerbations (≥2 per year) OR\n* Require prescription of daily or alternate day oral corticosteroids (OCS) to achieve asthma control despite the prescription of high dose inhaled corticosteroids (\\>1000mcg fluticasone propionate daily or equivalent) or maintenance oral corticosteroids plus a long acting beta agonist or one other controller medication (for example anti-cholinergics, leukotriene receptor antagonists or theophylline).\n\nDiagnosis of asthma for the asthma cohort: Subjects must have asthma according to one or more of the following criteria documented in the last 12 months\n\n* improvement in FEV1 ≥ 12% and 200ml predicted after inhalation of 400 mcg salbutamol\n* airway hyper-responsiveness (PC20 \\<8mg/ml)\n* diurnal variation in PEF: amplitude % mean of twice daily PEF \\> 8%\n* decrease in pre bronchodilator FEV1 \\>12% and \\>200mls within 4 weeks after tapering treatment with one or more of the following drugs: inhaled corticosteroids, oral corticosteroids, long-acting beta-agonists, long-acting beta-agonists and short-acting beta-agonists.\n\nPLUS a history of wheeze occurring spontaneously or on exertion\n\nExclusion Criteria:\n\n* Current smoker, or Ex-smoker with a \\>10 year pack history or having smoked within the past 6 months.\n* Significant alternative diagnoses that may mimic or complicate asthma, in particular dysfunctional breathing, panic attacks, and overt psychosocial problems (if these are thought to be the major problem rather than in addition to severe asthma)\n* Significant other primary pulmonary disorders in particular pulmonary embolism, pulmonary hypertension, interstitial lung disease and lung cancer\n* Subjects with emphysema and bronchiectasis should only be excluded if this is thought to be the major pulmonary disorder rather than in addition to severe asthma\n* Diagnosis or current investigation of occupational asthma\n* Any subjects currently participating, or having participated within 3 months of the first dose in a study using a new molecular entity, or the first dose in any other study investigating drugs.'}, 'identificationModule': {'nctId': 'NCT02703467', 'briefTitle': 'Exhaled Hydrogen Sulphide as a Biomarker of Airways Disease in Asthma', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'Exhaled Hydrogen Sulphide as a Biomarker of Airways Disease in Asthma', 'orgStudyIdInfo': {'id': '13/LO/1453'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy', 'description': 'Healthy subjects will have no significant medical history and no previous history of asthma or other serious illnesses. They should be non-smokers. The investigators willl measure spirometry and ensure that the values lie within the normal predicted range.'}, {'label': 'Asthmatics', 'description': 'Patients diagnosed as having asthma will be recruited from Royal Brompton Hospital Asthma Clinics. These patients will have a range of severity of asthma ranging from mild-moderate to severe asthma patients. The diagnosis of asthma is ascertained as described in the inclusion criteria.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SW3 6HP', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal Brompton Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Kian F Chung, MBBS MD FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College London'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'collaborators': [{'name': 'Royal Brompton & Harefield NHS Foundation Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}