Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
Study NCT ID:
NCT03760120
Status:
COMPLETED
Last Update Posted:
2022-12-29
First Post:
2018-11-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Short-term Effects of Physiotherapy on LCI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Technicians performing multiple-breath washout tests are blinded to treatment allocation; physiotherapists performing the treatment are blinded to multiple breath washout results; patients are blinded to the purpose of the study; the statistician will be blind to treatment allocation together with outcome assessors.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Cross-over randomized controlled trial. Procedure: two nitrogen multiple-breath washout tests, one before and one after the intervention with PEP-Mask, either standard or sham allocation, during two subsequent mornings.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-28', 'studyFirstSubmitDate': '2018-11-07', 'studyFirstSubmitQcDate': '2018-11-28', 'lastUpdatePostDateStruct': {'date': '2022-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of PEP-MASK on ventilation heterogeneity (Sacin)', 'timeFrame': 'Right after intervention/sham procedure', 'description': 'Acinar airways (Sacin) mean difference between treatments'}], 'secondaryOutcomes': [{'measure': 'Effect of PEP-MASK on ventilation heterogeneity (Scond)', 'timeFrame': 'Right after intervention/sham procedure', 'description': 'Conductive airways (Scond) mean difference between treatments'}, {'measure': 'Effect of PEP-MASK on ventilation heterogeneity (LCI)', 'timeFrame': 'Right after intervention/sham procedure', 'description': 'Ventilation heterogeneity (LCI) mean difference between treatments'}, {'measure': 'Sputum weight', 'timeFrame': 'From the beginning to the end of each intervention/sham procedure', 'description': 'Sputum weight (grams) will be collected throughout the active or sham interventions'}, {'measure': 'Oxygen saturation', 'timeFrame': 'From the beginning to the end of each intervention/sham procedure', 'description': 'Oxygen saturation (SpO2) will be monitored throughout the active or sham interventions'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['physiotherapy', 'pulmonary function'], 'conditions': ['Cystic Fibrosis']}, 'referencesModule': {'references': [{'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.'}], 'seeAlsoLinks': [{'url': 'http://www.mbwtraining.com/ECFS_MBW_SOP.pdf', 'label': 'Standard Operating Procedures LCI'}]}, 'descriptionModule': {'briefSummary': 'Although some studies have brought some evidences about the efficacy of positive expiratory pressure (PEP)-mask therapy as an airway clearance technique, yet it is not clearly understood what is the contribution of this technique in modifying peripheral ventilation inhomogeneity, a typical feature of patients with Cystic Fibrosis (CF).\n\nThe aim of this study is to investigate how PEP-MASK affects ventilation inhomogeneity in children and adolescents, with moderate to normal CF lung disease by the change in acinar airways (Sacin), lung clearance index (LCI) and conductive airways (Scond) indexes derived from nitrogen multiple-breath washout test (N2MBW).', 'detailedDescription': 'Investigational device: PEP-MASK=Positive Expiratory Pressure delivered through a face mask.\n\nStandard Operating Procedures used for evaluating CF lung disease and ventilation inhomogeneity.\n\nSample size: Based on preliminary data collected on seven subjects who performed nitrogen multiple-breath washout test before and after PEP-MASK, assuming a variation of 20% of Sacin, the study requires a sample size of 18 subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CF diagnosis\n* Patients hospitalized for a scheduled intravenous antibiotics cycle and regularly followed-up by the CF Centre\n* ≥ 15 kilograms\n* FEV1 ≥ 40%predicted\n* Ability to perform NMBW test\n* Ability to perform spirometry\n* Willing to adhere to protocol procedures\n* Patients in treatment with PEP-MASK\n\nExclusion Criteria:\n\n* Pulmonary Exacerbation within two last week\n* Burkholderia cepacia infection\n* Patients in lung transplantation waiting list\n* Patients undergoing non invasive mechanical ventilation or oxygen therapy'}, 'identificationModule': {'nctId': 'NCT03760120', 'acronym': 'SPICy', 'briefTitle': 'Short-term Effects of Physiotherapy on LCI', 'organization': {'class': 'OTHER', 'fullName': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico"}, 'officialTitle': 'Short-term Effects of Positive Expiratory Pressure Mask on Ventilation Inhomogeneity in Children and Adolescents With Cystic Fibrosis', 'orgStudyIdInfo': {'id': '2291'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PEP standard', 'interventionNames': ['Device: PEP-MASK']}, {'type': 'SHAM_COMPARATOR', 'label': 'PEP sham', 'interventionNames': ['Device: PEP-MASK']}], 'interventions': [{'name': 'PEP-MASK', 'type': 'DEVICE', 'armGroupLabels': ['PEP sham', 'PEP standard']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Florence', 'country': 'Italy', 'facility': 'Azienda Ospedaliero-Universitaria Meyer', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Centro Regionale di Riferimento Fibrosi Cistica', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'overallOfficials': [{'name': 'Carla Colombo', 'role': 'STUDY_DIRECTOR', 'affiliation': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}