Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-01-07 @ 11:28 PM
Study NCT ID:
NCT02543333
Status:
COMPLETED
Last Update Posted:
2018-07-10
First Post:
2015-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of Structured Light Plethysmography: Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 183}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-07', 'studyFirstSubmitDate': '2015-08-28', 'studyFirstSubmitQcDate': '2015-09-03', 'lastUpdatePostDateStruct': {'date': '2018-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in SLP Parameters after Bronchodilator Reversibility Test', 'timeFrame': 'Baseline and 15 minutes after bronchodilator reversibility test (in asthma patients)', 'description': 'SLP breathing parameters derived from the movement of the thoracoabdominal (TA) wall during tidal breathing.'}, {'measure': 'Difference in SLP Parameters between Asthma Patients and Healthy Subjects', 'timeFrame': 'Baseline', 'description': 'SLP breathing parameters derived from the movement of the thoracoabdominal (TA) wall during tidal breathing.'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in Forced Expiratory Volume in 1 second (FEV1) after Bronchodilator Reversibility Test', 'timeFrame': 'Baseline and 15 minutes after bronchodilator reversibility test (in asthma patients)', 'description': 'Measurement of FEV1 before and after bronchodilator'}, {'measure': 'Change from Baseline in Forced Vital Capacity (FVC) after Bronchodilator Reversibility Test', 'timeFrame': 'Baseline and 15 minutes after bronchodilator reversibility test (in asthma patients)', 'description': 'Measurement of FEV1 before and after bronchodilator'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute Asthma,'], 'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '15994402', 'type': 'BACKGROUND', 'citation': 'Miller MR, Crapo R, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. General considerations for lung function testing. Eur Respir J. 2005 Jul;26(1):153-61. doi: 10.1183/09031936.05.00034505. No abstract available.'}, {'pmid': '16055882', 'type': 'BACKGROUND', 'citation': 'Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.'}, {'type': 'BACKGROUND', 'citation': 'de Boer WH, Lasenby J, Cameron J, Wareham R, Ahmad S, Roach C, Hills W, Iles R. SLP: a zero-contact non-invasive method for pulmonary function testing. In: Labrosse F, Zwiggelaar R, Liu Y, Tiddeman B, eds, Proceedings of the British Machine Vision Conference. BMVA Press, 2010; pp 85.1-85.12'}, {'pmid': '6701820', 'type': 'BACKGROUND', 'citation': 'Morgan MD, Gourlay AR, Denison DM. An optical method of studying the shape and movement of the chest wall in recumbent patients. Thorax. 1984 Feb;39(2):101-6. doi: 10.1136/thx.39.2.101.'}, {'pmid': '29932498', 'type': 'DERIVED', 'citation': 'Hmeidi H, Motamedi-Fakhr S, Chadwick EK, Gilchrist FJ, Lenney W, Iles R, Wilson RC, Alexander J. Tidal breathing parameters measured by structured light plethysmography in children aged 2-12 years recovering from acute asthma/wheeze compared with healthy children. Physiol Rep. 2018 Jun;6(12):e13752. doi: 10.14814/phy2.13752.'}]}, 'descriptionModule': {'briefSummary': "Validation of Structured Light Plethysmography (SLP) in patients with asthma, in patients with acute asthma; an observational study in healthy participants and during patients' clinical investigation of broncho-reversibility in the asthma groups.", 'detailedDescription': "A non-randomised observational study to validate Structured Light Plethysmography in three groups of participants: those with stable asthma and those with acute asthma, who are undergoing routine clinical investigation of broncho-reversibility using spirometry. We will also observe a normal healthy group who will receive no clinical intervention. SLP data capture and spirometry (as part of the patients clinical care) will be performed before and after a Bronchodilator reversibility test which is part of the patients normal clinical care (except in the normal healthy group where no bronchodilator will be given). The data collected from this study will allow us to examine the effect of bronchodilators on breathing patterns in these patients and also compare breathing patterns in asthma patients to those in healthy individuals.\n\nThe participant will wear a plain white t-shirt. Alternatively, the measurement can be taken on bare skin or with the participant (if female) wearing a plain material white bra. The participant is asked to sit down on a chair or lie down with their neck in a neutral position and their back as straight as possible in front of the SLP device (Thora-3Di, Pneumacare Ltd). The projector is lined up to project the grid of light over the participant's chest and upper abdomen. and will be instructed to perform a period of 5 minutes of tidal breathing, They will otherwise be asked to remain as still as possible throughout the measurement. During the sequence of breathing, thoracoabdominal wall movements will be captured by the device.\n\nparticipant on completion of their Bronchodilator Challenge within the Lung Function Department or clinic\n\nThe SLP measurement is repeated on completion of their Bronchodilator reversibility test within the Lung Function Department or clinic."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "100 participants between the ages of 2 and 80 with stable asthma who are undergoing routine clinical investigation of broncho-reversibilty.\n\n100 participants between the ages of 2 and 80 with acute asthma who are undergoing routine clinical investigation of broncho-reversibilty.\n\n100 participants between the ages of 2 and 80 with no history of respiratory disease ('Normal'). These participants will not undergo a bronchodilator challenge.", 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged between 2 and 80 years\n\nExclusion Criteria:\n\n* Patients with significant co morbidities resulting in clinical instability (assessed by the clinician at screening only):\n* obstructive sleep apnea, Apnoea hypopnoea index \\> 30 (if known)\n* An acute or chronic condition that, in the investigator's opinion, would limit the patient's ability to participate in the study\n* BMI \\> 40\n* Inability to consent/comply with trial protocol"}, 'identificationModule': {'nctId': 'NCT02543333', 'acronym': 'SLPBD', 'briefTitle': 'Validation of Structured Light Plethysmography: Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pneumacare Ltd'}, 'officialTitle': 'Validation of Structured Light Plethysmography: Pre- and Post- Bronchodilator Challenge', 'orgStudyIdInfo': {'id': 'PMC-T3D-002/2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Asthma', 'description': 'Patients attending outpatient clinic as part of their clinical care who have FEV1 less than 80% of predicted and are referred by their clinician for a bronchodilator test'}, {'label': 'Acute Asthma', 'description': 'Inpatients admitted for an acute asthma exacerbation'}, {'label': 'Normal', 'description': 'Participants with no current or previous diagnosis of a respiratory condition'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CB2 0QQ', 'city': 'Cambridge', 'state': 'Cambridgeshire', 'country': 'United Kingdom', 'facility': 'Cambridge University Hospitals Foundation Trust', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'ST4 6QG', 'city': 'Stoke-on-Trent', 'state': 'Staffordshire', 'country': 'United Kingdom', 'facility': 'Royal Stoke University Hospital', 'geoPoint': {'lat': 53.00415, 'lon': -2.18538}}], 'overallOfficials': [{'name': 'Richard Iles, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cambridge University Hospitals Trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pneumacare Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Cambridge University Hospitals NHS Foundation Trust', 'class': 'OTHER'}, {'name': 'University Hospitals of North Midlands NHS Trust', 'class': 'OTHER'}, {'name': 'Keele University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}