Ignite Creation Date:
2025-12-26 @ 3:58 PM
Ignite Modification Date:
2026-02-05 @ 9:06 PM
Study NCT ID:
NCT00984906
Status:
COMPLETED
Last Update Posted:
2010-06-08
First Post:
2009-09-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inspiratory Flow Parameters and Handling of Easyhaler and Turbuhaler Inhalers
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-06-07', 'studyFirstSubmitDate': '2009-09-23', 'studyFirstSubmitQcDate': '2009-09-24', 'lastUpdatePostDateStruct': {'date': '2010-06-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak inspiratory flow rate through the empty Easyhaler and Turbohaler inhalers', 'timeFrame': '1 Day'}], 'secondaryOutcomes': [{'measure': 'Other inspiratory flow parameters through the empty Easyhaler and Turbohaler inhalers measured at the same time with the peak inspiratory flow rate.', 'timeFrame': '1 Day'}, {'measure': 'Handling of the devices in the subpopulation of asthmatic children', 'timeFrame': '1 Day'}, {'measure': 'Acceptability of the inhalers in the subpopulation of asthmatic children', 'timeFrame': '1 Day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Asthma', 'Pulmonary Disease, Chronic Obstructive']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to measure the inspiratory flow that the different patient groups (asthmatic children, adults and elderly, as well as chronic obstructive pulmonary disease (COPD) patients) generate through empty Easyhaler (two versions) and Turbuhaler inhalers. In addition, the handling and acceptability of the inhalers will be compared in asthmatic children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent obtained.\n* Documented diagnosis of asthma and/or COPD (a range of different severities for both diseases).\n* Age: 6 years or above.\n\nExclusion Criteria:\n\n* Any severe chronic respiratory disease other than asthma or COPD.\n* Acute respiratory infection.\n* Concurrent participation in a clinical drug study.\n* Inability to perform repeatable spirometric measurements.\n* Any medical condition that in the opinion of the investigator would endanger the subject if he/she participates in the study (such as contraindications to spirometry).'}, 'identificationModule': {'nctId': 'NCT00984906', 'acronym': 'PIFECO', 'briefTitle': 'Inspiratory Flow Parameters and Handling of Easyhaler and Turbuhaler Inhalers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Orion Corporation, Orion Pharma'}, 'officialTitle': 'Inspiratory Flow Parameters and Device Handling With Empty Device-metered Dry Powder Inhalers, Easyhaler and Turbuhaler; an Open, Randomised, Multi Centre Study in Patients With Asthma or COPD', 'orgStudyIdInfo': {'id': '3103003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Empty Easyhaler type A', 'interventionNames': ['Other: Empty inhalers']}, {'type': 'OTHER', 'label': 'Empty Easyhaler type B', 'interventionNames': ['Other: Empty inhalers']}, {'type': 'OTHER', 'label': 'Empty Turbohaler', 'interventionNames': ['Other: Empty inhalers']}], 'interventions': [{'name': 'Empty inhalers', 'type': 'OTHER', 'otherNames': ['Empty device-metered dry powder inhaler Easyhaler (type A)', 'Empty device-metered dry powder inhaler Easyhaler (type B)', 'Empty device-metered dry powder inhaler Turbohaler'], 'description': 'Empty Easyhaler inhalers (type A and type B) and empty Turbohaler inhaler', 'armGroupLabels': ['Empty Easyhaler type A', 'Empty Easyhaler type B', 'Empty Turbohaler']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Helsinki', 'country': 'Finland', 'facility': 'Jorvi hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'city': 'Helsinki', 'country': 'Finland', 'facility': 'Skin and Allergy hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'Northern General Hospital', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'city': 'Sheffield', 'country': 'United Kingdom', 'facility': "Sheffield Children's Hospital", 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}], 'overallOfficials': [{'name': 'Satu Lähelmä, M.Sc.(Pharm)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Orion Corporation, Orion Pharma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Orion Corporation, Orion Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Satu Lähelmä/Clinical Study Director', 'oldOrganization': 'Orion Corporation, Orion Pharma'}}}}