Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2026-01-04 @ 1:43 PM
Study NCT ID:
NCT00404261
Status:
COMPLETED
Last Update Posted:
2012-10-18
First Post:
2006-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation Of Patient Satisfaction Of Metered Dose Inhaler (MDI) With Counter In Asthmatics And Chronic Obstructive Pulmonary Disease Patients (COPD).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2017-09-26', 'unreleaseDate': '2018-08-15'}], 'estimatedResultsFirstSubmitDate': '2017-09-26'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}, {'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': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068298', 'term': 'Fluticasone'}], 'ancestors': [{'id': 'D000730', 'term': 'Androstadienes'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-17', 'studyFirstSubmitDate': '2006-11-27', 'studyFirstSubmitQcDate': '2006-11-27', 'lastUpdatePostDateStruct': {'date': '2012-10-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient satisfaction questionnaires administered at baseline and at the end of treatment (day 30).', 'timeFrame': 'Day 30'}], 'secondaryOutcomes': [{'measure': 'Healthcare professional satisfaction questionnaires administered at baseline and at the end of treatment (day 30) Patient compliance as measured by the device counter readings at the end of treatment (day 30), compared to the baseline reading.', 'timeFrame': 'Day 30'}, {'measure': 'Healthcare professional satisfaction questionnaires Patient Compliance Safety Evaluations: adverse events', 'timeFrame': '8 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fluticasone Propionate', 'healthcare professional satisfaction', 'patient satisfaction', 'metered dose inhaler with counter', 'Salmeterol', 'Chronic Obstructive Pulmonary Disease (COPD)'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the level of satisfaction experienced by asthma or chronic obstructive pulmonary disease (COPD) patients when using the Fluticasone/Salmeterol HFA Metered Dose Inhaler (MDI) with counter, as compared to using Fluticasone/Salmeterol HFA MDI without counter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Outpatient\n* Documented physician diagnosis of asthma or COPD\n* Requires use of a controller and long acting beta 2 agonist\n* Ability to provided written informed consent\n\nExclusion Criteria:\n\n* Patients with life threatening asthma or COPD\n* Historical or current evidence of significant diseases\n* Immediate or delayed hypersensitivity to inhaled short acting beta2agonist or sympathomimetic drug or any component of the MDI formulation\n* History of drug or alcohol abuse Abnormal chest x ray not consistent with asthma or COPD\n* Use of supplemental oxygen; systemic corticosteroids; short acting beta2agonists other than VENTOLIN HFA; antibiotics for respiratory infections; anti-arrhythmics; anticonvulsants; central nervous system stimulants; tricyclic antidepressants and monoamine oxidase inhibitors.'}, 'identificationModule': {'nctId': 'NCT00404261', 'briefTitle': 'Evaluation Of Patient Satisfaction Of Metered Dose Inhaler (MDI) With Counter In Asthmatics And Chronic Obstructive Pulmonary Disease Patients (COPD).', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'An Open Label, Multicentre Study to Evaluate Patient Satisfaction With Fluticasone/Salmeterol HFA MDI With Counter in Adult Subjects (18 Years of Age and Older) With Asthma or COPD.', 'orgStudyIdInfo': {'id': '108835'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Arm 1', 'description': 'Fluticasone/Salmeterol HFA MDI without counter', 'interventionNames': ['Drug: Fluticasone/Salmeterol HFA']}, {'type': 'OTHER', 'label': 'Arm 2', 'description': 'Fluticasone/Salmeterol HFA MDI with counter', 'interventionNames': ['Drug: Fluticasone/Salmeterol HFA']}], 'interventions': [{'name': 'Fluticasone/Salmeterol HFA', 'type': 'DRUG', 'description': 'Fluticasone/Salmeterol HFA, 2 puffs twice daily', 'armGroupLabels': ['Arm 1', 'Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4066', 'city': 'Auchenflower', 'state': 'Queensland', 'country': 'Australia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -27.47443, 'lon': 152.99213}}, {'zip': '4510', 'city': 'Caboolture', 'state': 'Queensland', 'country': 'Australia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -27.08465, 'lon': 152.9511}}, {'zip': '4021', 'city': 'Kippa-Ring', 'state': 'Queensland', 'country': 'Australia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -27.22586, 'lon': 153.0835}}, {'zip': '6000', 'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-09-26', 'type': 'RELEASE'}, {'date': '2018-08-15', 'type': 'UNRELEASE'}], 'unpostedResponsibleParty': 'GlaxoSmithKline'}}}}