Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-02-25 @ 4:57 PM
Study NCT ID:
NCT03377920
Status:
UNKNOWN
Last Update Posted:
2017-12-19
First Post:
2017-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictive Value of Spirometric PIF to Produce PIF Rate Needed for the Use of Current DPI's.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-12-13', 'studyFirstSubmitDate': '2017-10-26', 'studyFirstSubmitQcDate': '2017-12-13', 'lastUpdatePostDateStruct': {'date': '2017-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PIFspiro', 'timeFrame': 'At inclusion (D0)', 'description': 'PIFspiro (L/s): PIF measurement from standardized spirometry (3 flow-volume measurements);'}, {'measure': 'PIFresist', 'timeFrame': 'At inclusion (D0)', 'description': 'PIFresist (L/min): PIF from In-check Dial (5 flow measurements with flow restrictor in 5 different positions)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Severe Asthma', 'COPD']}, 'descriptionModule': {'briefSummary': "The main aim is to study correlations between Peak inspiratory flow measured during a spirometry (PIFspiro) and Peak inspiratory flow measured over a pre-set resistance (PIFresist) in COPD patients and severe asthma patients. PIFresist will be measured using 5 different resistances, representing all DPI's relevant for the treatment of obstructive lung diseases. If this shows a distinct relationship between PIFspiro and PIFresist, PIFspiro cut-off points will be sought in an attempt to predict which patients are likely to be able to produce optimal flows for DPI use. If successful, this will make the actual measurement of PIFresist redundant in clinical practice. Also the relationship between PIFresist and device internal resistance in addition to PIFspiro (which corresponds to a very low resistance) will be examined.", 'detailedDescription': "The correct use of dry powder inhalers (DPI) crucially depends on the peak inspiratory flow (PIF) that the patient can generate when overcoming internal resistance of the inhaler device.\n\nIt has been shown that some patients cannot achieve sufficient peak inspiratory flows with some DPI's, especially in the elderly population. The In-check Dial device (Clement Clarke International Ltd, Harlow, UK) allows to measure these inspiratory flows for different pre-set resistances, representing different DPI's.\n\nStudy design: interventional, single center, single visit study\n\n30 Severe asthmatics and 70 COPD patients will be recruited in the UZ Brussel respiratory outpatient clinic.\n\nAll participants will provide written informed consent.\n\nPatients will perform:\n\n* pre-bronchodilator spirometry for the measurement of PIFspiro as per European respiratory Society/American Thoracic Society (ERS/ATS) guidelines for standard lung function5 (part of routine clinical follow-up).\n* 5 forced inspiratory manoeuvres using the In-check Dial device G16, set at 5 different resistances (performed in order of increasing resistance), yielding the PIFresist values for the different DPI's"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe asthmatics (M/F; \\> 20 y) entering the Belgian Severe Asthma Registry (BSAR)\n* COPD patients (GOLD stage II-IV; M/F; \\> 40 y)\n\nExclusion Criteria:\n\n* Inability to perform spirometry'}, 'identificationModule': {'nctId': 'NCT03377920', 'briefTitle': "Predictive Value of Spirometric PIF to Produce PIF Rate Needed for the Use of Current DPI's.", 'organization': {'class': 'OTHER', 'fullName': 'Universitair Ziekenhuis Brussel'}, 'officialTitle': "Predictive Value of Peak Inspiratory Flow Rate Derived From Spirometry to Determine the Patient's Ability to Produce Peak Inspiratory Flow Rate to Overcome the Resistance of Current Dry Powders Inhalers.", 'orgStudyIdInfo': {'id': '143201733083'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Severe asthma patients; COPD patients', 'description': 'Cross sectional study Lung function measurement', 'interventionNames': ['Device: In-check Dial device (Clement Clarke International Ltd, Harlow, UK)']}], 'interventions': [{'name': 'In-check Dial device (Clement Clarke International Ltd, Harlow, UK)', 'type': 'DEVICE', 'description': "* pre-bronchodilator spirometry for the measurement of PIFspiro as per ERS/ATS guidelines for standard lung function5 (part of routine clinical follow-up).\n* 5 forced inspiratory manoeuvres using the In-check Dial device G16, set at 5 different resistances (performed in order of increasing resistance), yielding the PIFresist values for the different DPI's", 'armGroupLabels': ['Severe asthma patients; COPD patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Anja Baeten', 'role': 'CONTACT'}], 'facility': 'UZ Brussel', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'centralContacts': [{'name': 'Shane Hanon', 'role': 'CONTACT', 'email': 'shane.hanon@uzbrussel.be', 'phone': '00324776841'}], 'overallOfficials': [{'name': 'Shane Hanon', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitair Ziekenhuis Brussel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitair Ziekenhuis Brussel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}