Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT05495256
Status:
COMPLETED
Last Update Posted:
2023-04-28
First Post:
2022-04-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Monitoring Metered Dose Inhalation (MDI) Volume and Timing With a Respimetrix Device in Obstructive Lung Disease.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-05-20', 'mcpReleaseN': 3, 'releaseDate': '2025-05-05'}], 'estimatedResultsFirstSubmitDate': '2025-05-05'}}, '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': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'patients are screened, consented, and all go through the inhaler training.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-03-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-26', 'studyFirstSubmitDate': '2022-04-19', 'studyFirstSubmitQcDate': '2022-08-08', 'lastUpdatePostDateStruct': {'date': '2023-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pressurized metered-dose inhaler (pMDI) performed after training using Respimetrix device', 'timeFrame': '2 weeks', 'description': 'Measure actuation timing, flow rate and volume after intervention'}], 'secondaryOutcomes': [{'measure': 'Describing baseline pressurized metered-dose inhaler (pMDI) technique', 'timeFrame': '2 weeks', 'description': 'Measure actuation timing, flow rate and volume before intervention.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Asthma', 'Copd']}, 'descriptionModule': {'briefSummary': 'To Determine whether use of the Respimetrix flow test device a) can determine "good" versus "poor" inhaler techniques, and b) the effects of the inhaler training on technique.', 'detailedDescription': "Good metered dose inhaler (MDI) technique is described as sitting or standing upright with the head slightly tilted back, exhaling fully, and then inhaling slowly and deeply as you activate the MDI. Common mistakes include: not exhaling fully; not inhaling deeply enough; inhaling too quickly, and not activating the MDI at the proper time.\n\nThis study will use the Respimetrix device with placebo to assess a patient's inhaler technique, provide training to patients who demonstrate poor inhaler technique, and remotely track a subject's breathing ability over time."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 18 years of age or older\n* Current diagnosis of asthma or Chronic obstructive pulmonary disease (COPD) patients\n* Patients must be willing and able to provide informed consent to participate in the the study.\n* Patients must be able to use a metered dose inhaler\n\nExclusion Criteria:\n\n* Contraindication to inhaler use\n* Tracheostomy\n* Incapacitating disability that interferes with the use of the inhaler or execution of the protocol\n* Unable to understand informed consent (e.g. non-English speakers)'}, 'identificationModule': {'nctId': 'NCT05495256', 'briefTitle': 'Monitoring Metered Dose Inhalation (MDI) Volume and Timing With a Respimetrix Device in Obstructive Lung Disease.', 'organization': {'class': 'OTHER', 'fullName': 'Pulmonary Critical Care Associates of Baltimore'}, 'officialTitle': 'Monitoring Metered Dose Inhalation (MDI) Volume and Timing With a Respimetrix Device in Obstructive Lung Disease.', 'orgStudyIdInfo': {'id': 'Respimetrix 2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'MDI Training', 'description': 'All participants are led through the MDI training with the Respimetrix Device. Protocol is within groups design.', 'interventionNames': ['Device: Respimetrix']}], 'interventions': [{'name': 'Respimetrix', 'type': 'DEVICE', 'description': 'The Respimetrix device has a low resistance airflow sensor with an inhaler to measure patients inspiratory airflow and volume. This device will thereby provide quantifiable measures of lung function and bronchodilator delivery.', 'armGroupLabels': ['MDI Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21286', 'city': 'Towson', 'state': 'Maryland', 'country': 'United States', 'facility': 'Pulmonary and Critical Care Associates Of Baltimor', 'geoPoint': {'lat': 39.4015, 'lon': -76.60191}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pulmonary Critical Care Associates of Baltimore', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gerresheimer', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Alan Schwartz', 'investigatorAffiliation': 'Pulmonary Critical Care Associates of Baltimore'}}}}