Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2026-02-27 @ 1:09 AM
Study NCT ID:
NCT00560105
Status:
COMPLETED
Last Update Posted:
2015-03-05
First Post:
2007-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Randomized Controlled Eight-Week Study of the Safety and Efficacy of the Lung Flute
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ssethi@buffalo.edu', 'phone': '716-862-7875', 'title': 'Dr. S. Sethy', 'organization': 'VA WNY Health Care System'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '8 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Acapella', 'description': 'Acapella : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®', 'otherNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Lung Flute', 'description': 'Lung Flute : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®', 'otherNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}], 'frequencyThreshold': '5.0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Safety and Efficacy of the Lung Flute Versus the Acapella for the Treatment of COPD in Adults. Twenty-four (24) Hour Dry Sputum Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acapella', 'description': 'Acapella : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®'}, {'id': 'OG001', 'title': 'Lung Flute', 'description': 'Lung Flute : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®'}], 'classes': [{'title': 'Sreening Event', 'categories': [{'measurements': [{'value': '11.9', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '14.5', 'spread': '3.3', 'groupId': 'OG001'}]}]}, {'title': 'Week1', 'categories': [{'measurements': [{'value': '14.4', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '14.3', 'spread': '3.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '14.5', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '14.2', 'spread': '3.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '11.8', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '15.2', 'spread': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '11.7', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '12.0', 'spread': '2.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '11.6', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '12.1', 'spread': '2.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'In order to test the overall treatment effect on dry sputum weight over the course of the study, mixed effects analysis were performed. These models allow us to account for the longitudinal nature of the data. We assumed that the observations collected within each patient were correlated; however, observations collected across patients were assumed to be independent. Dry sputum weights obtained prior to and at randomization were regarded as baseline measurements, while those obtained at week 1, 2, 4, 6 and 8 were examined for treatment effects.', 'unitOfMeasure': 'g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patient data included'}, {'type': 'SECONDARY', 'title': 'FEV1 - Baseline and Device Comparisons', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acapella', 'description': 'Acapella : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®'}, {'id': 'OG001', 'title': 'Lung Flute', 'description': 'Lung Flute : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®'}], 'classes': [{'title': 'Screening FEV1', 'categories': [{'measurements': [{'value': '1.43', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '1.38', 'spread': '0.14', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 FEV1', 'categories': [{'measurements': [{'value': '1.49', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '1.44', 'spread': '0.19', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Spirometric data was collected primarily to document safety of the interventions. Pre- and Post-bronchodilator spirometry was obtained at the randomization visit and at Week 8.', 'unitOfMeasure': 'liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A data collected included'}, {'type': 'SECONDARY', 'title': 'Quality of Life Questionnaire/Daily Diary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acapella', 'description': 'Acapella : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®'}, {'id': 'OG001', 'title': 'Lung Flute', 'description': 'Lung Flute : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®'}], 'classes': [{'title': 'Screening', 'categories': [{'measurements': [{'value': '45.5', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '51.9', 'spread': '3.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '45.0', 'spread': '4.2', 'groupId': 'OG000'}, {'value': '47.2', 'spread': '4.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': "St. George's Respiratory Questionnaire (SGRQ) is a well validated, widely used health status questionnaire specific for COPD. Its minimum important difference (MID) is 4 units. Unit of measure: 0 to 100 (100 = more limitation)", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patient data included'}, {'type': 'SECONDARY', 'title': 'Change in CCQ Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acapella', 'description': 'Acapella : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®'}, {'id': 'OG001', 'title': 'Lung Flute', 'description': 'Lung Flute : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®'}], 'classes': [{'title': 'Screening', 'categories': [{'measurements': [{'value': '2.53', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '3.24', 'spread': '0.30', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '2.29', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '2.82', 'spread': '0.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'The COPD Clinical Questionnaire (CCQ) is an objective validated tool to assess COPD symptoms. CCQ was measured at the randomization visit and at the end of the study visit at week 8. The CCQ is scaled 1 to 5. Five indicating no symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A patient population included'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Acapella', 'description': 'Acapella : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®'}, {'id': 'FG001', 'title': 'Lung Flute', 'description': 'Lung Flute : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'musculoskeletal chest discomfort with us', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'We recruited 45 subjects, of which 5 subjects either did not meet the initial inclusion/exclusion criteria (n=3) or did not meet the compliance criteria between the recruitment and randomization visit (n=2).', 'preAssignmentDetails': 'Of the 40 subjects who were randomized, 20 each were randomized to the 2 devices. Of these 40 subjects, 37 completed the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Acapella', 'description': 'Acapella : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®'}, {'id': 'BG001', 'title': 'Lung Flute', 'description': 'Lung Flute : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.9', 'spread': '1.6', 'groupId': 'BG000'}, {'value': '64.0', 'spread': '2.4', 'groupId': 'BG001'}, {'value': '62.5', 'spread': '2.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-04', 'studyFirstSubmitDate': '2007-11-15', 'resultsFirstSubmitDate': '2012-11-16', 'studyFirstSubmitQcDate': '2007-11-16', 'lastUpdatePostDateStruct': {'date': '2015-03-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-03-04', 'studyFirstPostDateStruct': {'date': '2007-11-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and Efficacy of the Lung Flute Versus the Acapella for the Treatment of COPD in Adults. Twenty-four (24) Hour Dry Sputum Weight', 'timeFrame': '8 weeks', 'description': 'In order to test the overall treatment effect on dry sputum weight over the course of the study, mixed effects analysis were performed. These models allow us to account for the longitudinal nature of the data. We assumed that the observations collected within each patient were correlated; however, observations collected across patients were assumed to be independent. Dry sputum weights obtained prior to and at randomization were regarded as baseline measurements, while those obtained at week 1, 2, 4, 6 and 8 were examined for treatment effects.'}], 'secondaryOutcomes': [{'measure': 'FEV1 - Baseline and Device Comparisons', 'timeFrame': '8 weeks', 'description': 'Spirometric data was collected primarily to document safety of the interventions. Pre- and Post-bronchodilator spirometry was obtained at the randomization visit and at Week 8.'}, {'measure': 'Quality of Life Questionnaire/Daily Diary', 'timeFrame': '8 weeks', 'description': "St. George's Respiratory Questionnaire (SGRQ) is a well validated, widely used health status questionnaire specific for COPD. Its minimum important difference (MID) is 4 units. Unit of measure: 0 to 100 (100 = more limitation)"}, {'measure': 'Change in CCQ Score', 'timeFrame': '8 weeks', 'description': 'The COPD Clinical Questionnaire (CCQ) is an objective validated tool to assess COPD symptoms. CCQ was measured at the randomization visit and at the end of the study visit at week 8. The CCQ is scaled 1 to 5. Five indicating no symptoms.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD'], 'conditions': ['COPD']}, 'descriptionModule': {'briefSummary': 'This is an eight-week, randomized, controlled, two arm parallel study. The study consists of, a screening visit, two weeks of intervention-free run-in randomization, clinic visits week 0, 1, 2, 4, 6, and 8 weeks during the intervention period to collect 24 hour sputum and to confirm techniques of device use and entries into daily diaries. Twenty-four (24) hour sputum samples will be collected and weighed at each clinic visit. In addition to clinic visits, subjects will be expected to make daily diary entries of COPD symptoms. Clinical evaluation will include adverse event surveillance, and St. Georges Respiratory questionnaire.', 'detailedDescription': 'No further details'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age of over 40 with COPD\n\nExclusion Criteria:\n\n* Children,\n* New mothers; and\n* Women intending to become pregnant'}, 'identificationModule': {'nctId': 'NCT00560105', 'briefTitle': 'Randomized Controlled Eight-Week Study of the Safety and Efficacy of the Lung Flute', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medical Acoustics LLC'}, 'officialTitle': 'A Proof of Principal Randomized Controlled Eight-Week Study of the Safety and Efficacy of the Lung Flute in Adults With Chronic Obstructive Pulmonary Disease. A FDA 510(k) Equivalency Study', 'orgStudyIdInfo': {'id': '1002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Acapella', 'description': 'The Active Comparator is the Acapella, a OPEP device', 'interventionNames': ['Device: Acapella']}, {'type': 'EXPERIMENTAL', 'label': 'Lung Flute', 'description': 'The Active Comparator is the Lung Flute, a new indication of this device', 'interventionNames': ['Device: Lung Flute']}], 'interventions': [{'name': 'Lung Flute', 'type': 'DEVICE', 'description': '8 weeks home use, twice daily', 'armGroupLabels': ['Lung Flute']}, {'name': 'Acapella', 'type': 'DEVICE', 'description': '8 weeks home use, twice daily', 'armGroupLabels': ['Acapella']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14215', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'VA Western NY Healthcare System', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Sanjay Sethi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Western NY Healthcare System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical Acoustics LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}