Ignite Creation Date:
2025-12-24 @ 12:12 PM
Ignite Modification Date:
2026-03-06 @ 5:32 PM
Study NCT ID:
NCT01832961
Status:
COMPLETED
Last Update Posted:
2020-02-27
First Post:
2013-03-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Acute Effects of a Flutter Device in COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D007249', 'term': 'Inflammation'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001945', 'term': 'Breathing Exercises'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ada@fmrp.usp.br', 'phone': '55 020 7351 8051', 'title': 'Ada Clarice Gastaldi', 'organization': 'Imperial College'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Absence of some objective measurement of dyspnea, well being or satisfaction scales.'}}, 'adverseEventsModule': {'timeFrame': '9 months', 'eventGroups': [{'id': 'EG000', 'title': 'Flutter Exercises', 'description': 'Flutter exercises: 30 minutes of breathing exercises with flutter device', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Flutter-sham', 'description': 'Flutter-sham: 30 minutes of flutter-sham exercises', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Flutter+Bronchodilator', 'description': 'Flutter+bronchodilator: Bronchodilator (Salbutamol) + 30 minutes of breathing exercises with flutter device', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Airways Resistance (IOS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Flutter Exercises Session', 'description': '30 minutes of breathing exercises with flutter device'}, {'id': 'OG001', 'title': 'Flutter+Bronchodilator Session', 'description': 'Bronchodilator (Salbutamol) + 30 minutes of breathing exercises with flutter device'}, {'id': 'OG002', 'title': 'Flutter-sham - Control Group', 'description': '30 minutes of exercise with flutter-sham device'}], 'classes': [{'title': 'R5 (kPa/L/s) Baseline', 'categories': [{'measurements': [{'value': '0.63', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '0.61', 'spread': '0.28', 'groupId': 'OG001'}, {'value': '0.58', 'spread': '0.15', 'groupId': 'OG002'}]}]}, {'title': 'R5 (kPa/L/s) Immediately after', 'categories': [{'measurements': [{'value': '0.68', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '0.63', 'spread': '0.26', 'groupId': 'OG001'}, {'value': '0.60', 'spread': '0.22', 'groupId': 'OG002'}]}]}, {'title': 'R5 (kPa/L/s) After 20 minutes of rest', 'categories': [{'measurements': [{'value': '0.61', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '0.56', 'spread': '0.24', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No data was collected from this group after 20 minuted of rest.', 'groupId': 'OG002'}]}]}, {'title': 'R20 (kPa/L/s) Baseline', 'categories': [{'measurements': [{'value': '0.42', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '0.41', 'spread': '0.15', 'groupId': 'OG001'}, {'value': '0.40', 'spread': '0.15', 'groupId': 'OG002'}]}]}, {'title': 'R20 (kPa/L/s) Immediately after', 'categories': [{'measurements': [{'value': '0.43', 'spread': '0.14', 'groupId': 'OG000'}, {'value': '0.42', 'spread': '0.16', 'groupId': 'OG001'}, {'value': '0.41', 'spread': '0.13', 'groupId': 'OG002'}]}]}, {'title': 'R20 (kPa/L/s) After 20 minutes of rest', 'categories': [{'measurements': [{'value': '0.41', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '0.39', 'spread': '0.14', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No data was collected from this group after 20 minuted of rest.', 'groupId': 'OG002'}]}]}, {'title': 'R5-R20 (kPa/L/s) Baseline', 'categories': [{'measurements': [{'value': '0.21', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.20', 'spread': '0.15', 'groupId': 'OG001'}, {'value': '0.19', 'spread': '0.10', 'groupId': 'OG002'}]}]}, {'title': 'R5-R20 (kPa/L/s) Immediately after', 'categories': [{'measurements': [{'value': '0.25', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '0.21', 'spread': '0.12', 'groupId': 'OG001'}, {'value': '0.19', 'spread': '0.11', 'groupId': 'OG002'}]}]}, {'title': 'R5-R20 (kPa/L/s) After 20 minutes of rest', 'categories': [{'measurements': [{'value': '0.20', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '0.25', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No data was collected from this group after 20 minuted of rest.', 'groupId': 'OG002'}]}]}, {'title': 'X5 (kPa/L/s) Baseline', 'categories': [{'measurements': [{'value': '-0.27', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '-0.27', 'spread': '0.15', 'groupId': 'OG001'}, {'value': '-0.23', 'spread': '0.08', 'groupId': 'OG002'}]}]}, {'title': 'X5 (kPa/L/s) Immediately after', 'categories': [{'measurements': [{'value': '-0.28', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '-0.25', 'spread': '0.11', 'groupId': 'OG001'}, {'value': '-0.24', 'spread': '0.09', 'groupId': 'OG002'}]}]}, {'title': 'X5 (kPa/L/s) After 20 minutes of rest', 'categories': [{'measurements': [{'value': '-0.26', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '-0.25', 'spread': '0.12', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No data was collected from this group after 20 minuted of rest.', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': "The statistical analysis compared the results: immediately after to baseline values, after 20 minutes of rest to baseline values and after 20 minutes of rest to values immediately after using Friedman's Test followed by Dunn's multiple comparison test", 'statisticalMethod': "Friedman's Test", 'nonInferiorityType': 'OTHER', 'statisticalComment': "Friedman's test followed by Dunn's multiple comparison", 'otherAnalysisDescription': 'The effect of size used to calculate responsiveness and classified as small (0.2), moderate (0.5) and large (0.8).'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline test, after breathing exercises with flutter or flutter-sham device and after 20 minutes of rest', 'description': 'Airways resistance were measured by impulse oscillometry (IOS) method.', 'unitOfMeasure': 'kPa/L/s', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with COPD, without upper respiratory tract infection or treatment with antibiotics within 4 weeks prior the study; without acute dyspnea or hemoptysis, and no recent history of rib fractures or pneumothorax.\n\nIn the Flutter-sham Control group after 20 minutes of rest - no data was collected.'}, {'type': 'PRIMARY', 'title': 'Airways Resistance (IOS) - Reactance Area (Ax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Flutter Exercises Session', 'description': '30 minutes of breathing exercises with flutter device'}, {'id': 'OG001', 'title': 'Flutter+Bronchodilator Session', 'description': 'Bronchodilator (Salbutamol) + 30 minutes of breathing exercises with flutter device'}, {'id': 'OG002', 'title': 'Flutter-sham - Control Group', 'description': '30 minutes of breathing exercises with flutter-sham device'}], 'classes': [{'title': 'Ax (kPa/L) Baseline', 'categories': [{'measurements': [{'value': '-0.13', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '-0.19', 'spread': '0.30', 'groupId': 'OG001'}, {'value': '1.89', 'spread': '1.18', 'groupId': 'OG002'}]}]}, {'title': 'Ax (kPa/L) Immediately after', 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '-0.20', 'spread': '0.26', 'groupId': 'OG001'}, {'value': '2.22', 'spread': '1.62', 'groupId': 'OG002'}]}]}, {'title': 'Ax (kPa/L) After 20 minutes of rest', 'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '-0.18', 'spread': '0.26', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No data was collected from this group after 20 minutes of rest.', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': "The statistical analysis compared the results: immediately after to baseline values, after 20 minutes of rest to baseline values and after 20 minutes of rest to values immediately after using Friedman's Test followed by Dunn's multiple comparison test", 'statisticalMethod': "Friedman's Test", 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The effect size was used to calculate responsiveness and classifed as small (0.2), moderate (0.5) and large (0.8)'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline test, after breathing exercises with flutter or flutter-sham device and after 20 minutes of rest', 'description': 'Airways resistance were measured by impulse oscillometry (IOS) method.', 'unitOfMeasure': 'kPa/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected from the Flutter-sham Control group after 20 minutes of rest.'}, {'type': 'PRIMARY', 'title': 'Airways Resistance (IOS) - Resonant Frequency (Fres)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Flutter Exercises Session', 'description': '30 minutes of breathing exercises with flutter device'}, {'id': 'OG001', 'title': 'Flutter+Bronchodilator Session', 'description': 'Bronchodilator (Salbutamol) + 30 minutes of breathing exercises with flutter device'}, {'id': 'OG002', 'title': 'Flutter-sham - Control Group', 'description': '30 minutes of breathing exercise with flutter-sham device'}], 'classes': [{'title': 'Fres (Hz) Baseline', 'categories': [{'measurements': [{'value': '24.95', 'spread': '4.03', 'groupId': 'OG000'}, {'value': '22.54', 'spread': '7.70', 'groupId': 'OG001'}, {'value': '22.13', 'spread': '5.71', 'groupId': 'OG002'}]}]}, {'title': 'Fres (Hz) Immediately after', 'categories': [{'measurements': [{'value': '26.15', 'spread': '4.78', 'groupId': 'OG000'}, {'value': '23.49', 'spread': '6.14', 'groupId': 'OG001'}, {'value': '22.41', 'spread': '8.24', 'groupId': 'OG002'}]}]}, {'title': 'Fres (Hz) After 20 minutes of rest', 'categories': [{'measurements': [{'value': '24.24', 'spread': '4.29', 'groupId': 'OG000'}, {'value': '21.85', 'spread': '7.01', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No data was collect from this group after 20 minutes of rest.', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': "The statistical analysis compared the results: immediately after to baseline values, after 20 minutes of rest to baseline values and after 20 minutes of rest to values immediately after using Friedman's Test followed by Dunn's multiple comparison test", 'statisticalMethod': "Friedman's Test", 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The effect size was used to calculate responsiveness and classifed as small (0.2), moderate (0.5) and large (0.8)'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline test, after breathing exercises with flutter or flutter-sham device and after 20 minutes of rest', 'description': 'Airways resistance were measured by impulse oscillometry (IOS) method.', 'unitOfMeasure': 'Hz', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected from the Flutter-sham Control group after 20 minutes of rest.'}, {'type': 'SECONDARY', 'title': 'Exhaled Nitric Oxide (FeNO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Flutter Exercises', 'description': 'Flutter exercises: 30 minutes of breathing exercises with flutter device'}, {'id': 'OG001', 'title': 'Flutter-sham', 'description': 'Flutter-sham: 30 minutes of flutter-sham exercises'}, {'id': 'OG002', 'title': 'Flutter+Bronchodilator', 'description': 'Flutter+bronchodilator: Bronchodilator (Salbutamol) + 30 minutes of breathing exercises with flutter device'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '40.5', 'spread': '29.9', 'groupId': 'OG000'}, {'value': '44.4', 'spread': '33.7', 'groupId': 'OG001'}, {'value': '32.3', 'spread': '29.4', 'groupId': 'OG002'}]}]}, {'title': 'After intervention', 'categories': [{'measurements': [{'value': '39.3', 'spread': '33.7', 'groupId': 'OG000'}, {'value': '43.6', 'spread': '33.2', 'groupId': 'OG001'}, {'value': '31.7', 'spread': '32.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'T-test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'T-test was used to comparisons before and after FeNO results'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and immediately after intervention', 'description': 'Exhaled nitric oxide will be measured by chemiluminescence method.', 'unitOfMeasure': 'parts per billion', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with COPD, without upper respiratory tract infection or treatment with antibiotics within 4 weeks prior the study; without acute dyspnea or hemoptysis and no recent history of rib fracture or pneumothorax.'}, {'type': 'SECONDARY', 'title': 'Spirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Flutter Exercises', 'description': 'Flutter exercises: 30 minutes of breathing exercises with flutter device'}, {'id': 'OG001', 'title': 'Flutter-sham', 'description': 'Flutter-sham: 30 minutes of flutter-sham exercises'}, {'id': 'OG002', 'title': 'Flutter+Bronchodilator', 'description': 'Flutter+bronchodilator: Bronchodilator (Salbutamol) + 30 minutes of breathing exercises with flutter device'}], 'classes': [{'title': 'Baseline FVC (%)', 'categories': [{'measurements': [{'value': '109.4', 'spread': '18.4', 'groupId': 'OG000'}, {'value': '109.8', 'spread': '19.6', 'groupId': 'OG001'}, {'value': '105.8', 'spread': '16.2', 'groupId': 'OG002'}]}]}, {'title': 'After intervention FVC (%)', 'categories': [{'measurements': [{'value': '107.3', 'spread': '18.1', 'groupId': 'OG000'}, {'value': '109.0', 'spread': '17.5', 'groupId': 'OG001'}, {'value': '102.1', 'spread': '18.0', 'groupId': 'OG002'}]}]}, {'title': 'Baseline FEV1 (%)', 'categories': [{'measurements': [{'value': '67.6', 'spread': '17.7', 'groupId': 'OG000'}, {'value': '67.0', 'spread': '17.3', 'groupId': 'OG001'}, {'value': '62.1', 'spread': '16.7', 'groupId': 'OG002'}]}]}, {'title': 'After intervention FEV1 (%)', 'categories': [{'measurements': [{'value': '66.0', 'spread': '15.5', 'groupId': 'OG000'}, {'value': '65.3', 'spread': '14.6', 'groupId': 'OG001'}, {'value': '60.3', 'spread': '17.1', 'groupId': 'OG002'}]}]}, {'title': 'Baseline FEV1/FVC (%)', 'categories': [{'measurements': [{'value': '51.0', 'spread': '13.0', 'groupId': 'OG000'}, {'value': '50.3', 'spread': '12.0', 'groupId': 'OG001'}, {'value': '48.5', 'spread': '12.8', 'groupId': 'OG002'}]}]}, {'title': 'After intervention FEV1/FVC (%)', 'categories': [{'measurements': [{'value': '51.0', 'spread': '12.5', 'groupId': 'OG000'}, {'value': '49.7', 'spread': '10.8', 'groupId': 'OG001'}, {'value': '48.9', 'spread': '12.8', 'groupId': 'OG002'}]}]}, {'title': 'Baseline MEF 25-75 (%)', 'categories': [{'measurements': [{'value': '18.93', 'spread': '8.0', 'groupId': 'OG000'}, {'value': '17.8', 'spread': '6.8', 'groupId': 'OG001'}, {'value': '15.7', 'spread': '6.4', 'groupId': 'OG002'}]}]}, {'title': 'After intervention MEF 25-75 (%)', 'categories': [{'measurements': [{'value': '18.0', 'spread': '7.1', 'groupId': 'OG000'}, {'value': '17.6', 'spread': '6.9', 'groupId': 'OG001'}, {'value': '15.1', 'spread': '7.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'T-test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and immediately after intervention', 'description': 'Forced expiratory volume in 1s (FEV1) and forced vital capacity (FVC) were measured using a dry wedge spirometer (Jaeger Co, Wurzburg, Germany)', 'unitOfMeasure': 'percent predicted spirometry assessment', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with COPD, without upper respiratory tract infection or treatment with antibiotics within 4 weeks prior the study; without acute dyspnea or hemoptysis and no recent history of rib fracture or pneumothorax.'}, {'type': 'SECONDARY', 'title': 'Cough', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Flutter Exercises Session', 'description': '30 minutes of breathing exercises with flutter device'}, {'id': 'OG001', 'title': 'Flutter-sham Exercises Session', 'description': '30 minutes of breathing exercises with a flutter-sham device'}, {'id': 'OG002', 'title': 'Flutter+Bronchodilator Session', 'description': 'Pretreatment with a short-acting bronchodilator and 01 hour later they performed flutter exercises during 30 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '3.95', 'spread': '2.41', 'groupId': 'OG000'}, {'value': '1.69', 'spread': '1.49', 'groupId': 'OG001'}, {'value': '3.63', 'spread': '3.07', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During each session', 'description': 'Number of spontaneously reported cough episodes during each visit were collected.', 'unitOfMeasure': 'Coughs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with COPD, without upper respiratory tract infection or treatment with antibiotics within 4 weeks prior the study; without acute dyspnea or hemoptysis and no recent history of rib fracture or pneumothorax.'}, {'type': 'SECONDARY', 'title': 'Secretion - Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flutter Exercises Session', 'description': '30 minutes of breathing exercises with flutter device'}, {'id': 'OG001', 'title': 'Flutter-sham Exercises Session', 'description': '30 minutes of breathing exercises with a flutter-sham device'}], 'classes': [{'categories': [{'measurements': [{'value': '2.54', 'spread': '1.39', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '1.33', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During each session', 'description': 'Expectorated secretion volume during each visit were collected, weighted and classified with a purulence score.', 'unitOfMeasure': 'grams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'COPD patients without upper respiratory tract infection or treatment with antibiotics within 4 weeks prior the study; without acute dyspnea or hemoptysis and no recent history of a rib fracture or pneumothorax\n\nThe volume fo secretion was obtained only for two groups: Flutter exercises and flutter-sham exercises.'}, {'type': 'SECONDARY', 'title': 'Secretion - Purulence Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Flutter Exercises Session', 'description': '30 minutes of breathing exercises with flutter device'}, {'id': 'OG001', 'title': 'Flutter-sham Exercises Session', 'description': '30 minutes of breathing exercises with a flutter-sham device'}, {'id': 'OG002', 'title': 'Flutter+Bronchodilator Session', 'description': 'Pretreatment with a short-acting bronchodilator and 01 hour later they performed flutter exercises during 30 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '2.30', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '2.57', 'spread': '0.79', 'groupId': 'OG001'}, {'value': '2.60', 'spread': '1.34', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'In each session', 'description': 'The expectorated secretion was collected, weighted and classified with a purulence score based on a previously described numerical visual scale, which ranges from 1 (mucoid) to 5 (yellow/green).\n\nReferee of the Purulence score: Barnes PJ, Dweik RA, Gelb AF, et al. Exhaled nitric oxide in pulmonary diseases: a comprehensive review. Chest. 2010;138:682-692.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'COPD patients without upper respiratory tract infection or treatment with antibiotics within 4 weeks prior the study; without acute dyspnea or hemoptysis and no recent history of a rib fracture or pneumothorax.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Flutter Valve, Then Flutter Sham and Flutter+Bronchodilator', 'description': 'Visit 1: medical history, physical examination and written informed consent\n\nVisit 2: FeNO, IOS and spirometry + 30 minutes of breathing exercises with flutter device\n\nVisit 3: FeNO, IOS and spirometry + 30 minutes of flutter-sham exercises\n\nVisit 4: FeNO, IOS and spirometry + bronchodilator (Salbutamol) + 30 minutes of breathing exercises with flutter device'}, {'id': 'FG001', 'title': 'Flutter Sham, Then Flutter Valve and Flutter+Bronchodilator', 'description': 'Visit 1: medical history, physical examination and written informed consent\n\nVisit 2: FeNO, IOS and spirometry + 30 minutes of flutter-sham exercises\n\nVisit 3: FeNO, IOS and spirometry + 30 minutes of breathing exercises with flutter device\n\nVisit 4: FeNO, IOS and spirometry + bronchodilator (Salbutamol) + 30 minutes of breathing exercises with flutter device'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Third Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Patient', 'description': 'All volunteers had a following treatments as crossover design Visit 1: medical history, physical examination and written informed consent\n\nVisit 2: FeNO, IOS and spirometry + 30 minutes of breathing exercises with flutter device\n\nVisit 3: FeNO, IOS and spirometry + 30 minutes of flutter-sham exercises\n\nVisit 4: FeNO, IOS and spirometry + bronchodilator (Salbutamol) + 30 minutes of breathing exercises with flutter device'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '67.3', 'spread': '9.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-13', 'studyFirstSubmitDate': '2013-03-25', 'resultsFirstSubmitDate': '2019-08-14', 'studyFirstSubmitQcDate': '2013-04-12', 'lastUpdatePostDateStruct': {'date': '2020-02-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-13', 'studyFirstPostDateStruct': {'date': '2013-04-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Airways Resistance (IOS)', 'timeFrame': 'Baseline test, after breathing exercises with flutter or flutter-sham device and after 20 minutes of rest', 'description': 'Airways resistance were measured by impulse oscillometry (IOS) method.'}, {'measure': 'Airways Resistance (IOS) - Reactance Area (Ax)', 'timeFrame': 'Baseline test, after breathing exercises with flutter or flutter-sham device and after 20 minutes of rest', 'description': 'Airways resistance were measured by impulse oscillometry (IOS) method.'}, {'measure': 'Airways Resistance (IOS) - Resonant Frequency (Fres)', 'timeFrame': 'Baseline test, after breathing exercises with flutter or flutter-sham device and after 20 minutes of rest', 'description': 'Airways resistance were measured by impulse oscillometry (IOS) method.'}], 'secondaryOutcomes': [{'measure': 'Exhaled Nitric Oxide (FeNO)', 'timeFrame': 'Baseline and immediately after intervention', 'description': 'Exhaled nitric oxide will be measured by chemiluminescence method.'}, {'measure': 'Spirometry - Forced Expiratory Volume at 1 Second (FEV1) and Forced Vital Capacity (FVC)', 'timeFrame': 'Baseline and immediately after intervention', 'description': 'Forced expiratory volume in 1s (FEV1) and forced vital capacity (FVC) were measured using a dry wedge spirometer (Jaeger Co, Wurzburg, Germany)'}, {'measure': 'Cough', 'timeFrame': 'During each session', 'description': 'Number of spontaneously reported cough episodes during each visit were collected.'}, {'measure': 'Secretion - Volume', 'timeFrame': 'During each session', 'description': 'Expectorated secretion volume during each visit were collected, weighted and classified with a purulence score.'}, {'measure': 'Secretion - Purulence Score', 'timeFrame': 'In each session', 'description': 'The expectorated secretion was collected, weighted and classified with a purulence score based on a previously described numerical visual scale, which ranges from 1 (mucoid) to 5 (yellow/green).\n\nReferee of the Purulence score: Barnes PJ, Dweik RA, Gelb AF, et al. Exhaled nitric oxide in pulmonary diseases: a comprehensive review. Chest. 2010;138:682-692.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COPD', 'physiotherapy care', 'lung function testing', 'inflammation'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '26496331', 'type': 'RESULT', 'citation': 'Gastaldi AC, Paredi P, Talwar A, Meah S, Barnes PJ, Usmani OS. Oscillating Positive Expiratory Pressure on Respiratory Resistance in Chronic Obstructive Pulmonary Disease With a Small Amount of Secretion: A Randomized Clinical Trial. Medicine (Baltimore). 2015 Oct;94(42):e1845. doi: 10.1097/MD.0000000000001845.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4620777/', 'label': 'Gastaldi AC, et al. Oscillating Positive Expiratory Pressure on Respiratory Resistance in Chronic Obstructive Pulmonary Disease With a Small Amount of Secretion: A Randomized Clinical Trial. Medicine (Baltimore) 2015; 94(42): 1-8.'}]}, 'descriptionModule': {'briefSummary': 'Chronic obstructive pulmonary disease (COPD) is characterised by airflow limitation that is not fully reversible, and is usually progressive and associated with an abnormal inflammatory response of the lungs to noxious particles or gases, most commonly cigarette smoking. The disease affects not only the large central airways but also the small, more peripheral airways deeper into the lung, defined as less than 2 mm in diameter.\n\nBesides medical treatment, physiotherapy plays a major role in treatment and various methods have been suggested to remove airway of secretions. The flutter is a simple and small device shaped like a pipe that creates a positive expiratory pressure (PEP) and high frequency oscillation when the expired air passes through it. These vibrations are thought to mobilise airway secretions facilitating their clearance and improving breathing.\n\nStandard blowing tests, like spirometry, where patients blow forcedly into a machine, have previously been used to investigate the efficacy of flutter devices. However, spirometry assesses the damage of larger airways but not small airways, also known as the "silent zone" which, crucially, are specifically damaged in COPD.\n\nIn this study the investigators hypothesise that because the flutter helps clear the airways from the excessive thick mucus produced by COPD patients, these patients may find it easier to breathe and have lower resistance to moving air in and out of their lungs.\n\nThe main objective of this study is to compare the effect of a flutter or a sham device on small airways damage using impulse oscillometry (IOS), a non-invasive method that, contrary to other common blowing tests, measures small airway resistance during normal breathing.\n\nIn addition, because COPD is characterised by inflammation, the investigators would also like to measure a gas the patients blow out, nitric oxide (NO) the levels of which reflect airway inflammation. This will give to investigators an insight into the relationship between airway inflammation and small airway function.', 'detailedDescription': 'Chronic obstructive pulmonary disease (COPD) is characterised by airflow limitation that is not fully reversible. This limitation is usually progressive and associated with an abnormal inflammatory response of the lungs to noxious particles or gases.\n\nPatients suffering from COPD may show pathologic changes not only in the large but also in the small airways, which are defined as less than 2mm in diameter. Airway inflammation may cause increased thick mucus secretions which can narrow the airways increasing the resistance to the airflow.\n\nPhysiotherapy to remove secretions is indicated for patients with COPD who have regular sputum or those with thick secretions and various techniques and physiotherapy devices can be applied for the removal of secretions. The flutter is a simple and small device shaped like a pipe that creates a positive expiratory pressure (PEP) and high frequency oscillation as expired air passes through it. These vibrations and PEP are thought to mobilise airway secretions facilitating their clearance and improving airflow.\n\nThe effects of the flutter device have been studied in different patient groups, but especially in lung diseases characterised by mucus hypersecretion such as COPD, cystic fibrosis and bronchiectasis. In COPD, even though the flutter device increases the volume of expectorated secretions, its beneficial effects on pulmonary function as assessed by spirometry and plethysmography are inconclusive. However, these standard lung function tests (such as spirometry) asses the large airways, but do not provide an accurate estimate of the small airways which have been described by some authors as "the silent zone".\n\nThe investigators hypothesise that the use of impulse oscillometry (IOS), a non-invasive technique that provides information on small airway resistance during normal breathing, may reveal the effect of the flutter device which may have not been accurately measured by spirometry in previous studies.\n\nIn addition, the investigators would like to measure exhaled nitric oxide (NO) levels which reflect airway inflammation and may therefore be useful to determine the association between small airway disease and inflammation.\n\nIn summary, the symptoms of patients with COPD improve following breathing exercises with a flutter device, however, the effect of this device on lung function is unclear. The investigators hypothesise that the combined use IOS and NO, would help understand and quantify the effects of the flutter device on the small airways disease in COPD.\n\nThe main objective of this study is to measure the effect of a 30 minutes breathing exercise with a flutter device on airway resistance as assessed by impulse oscillometry in patients with COPD.\n\nThe secondary objective is to investigate the association between inflammation, airway resistance and volume of secretions in COPD patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- patients with COPD meeting the Global Initiative for Obstructive Lung Disease (GOLD) guidelines, with forced expiratory volume in the first second of expiration (FEV1) \\<80% predicted, FEV1/FVC ratio \\<70% predicted (FVC= forced vital capacity), and total lung capacity (TLC) \\>80% predicted), with or without sputum, will be included.\n\nThe severity of COPD will be classified according to GOLD criteria:\n\nStage I: mild FEV1/FVC\\<0.70 and FEV1\\>80% predicted; Stage II: moderate FEV1/FVC\\<0.70 and 50\\<FEV1\\<80% predicted; Stage III: severe FEV1/FVC\\<0.70 and 30\\<FEV1\\<50% predicted; Stage IV: very severe FEV1/FVC\\<0.70 and FEV1\\<30% or FEV1\\<50% predicted plus chronic respiratory failure,\n\nExclusion Criteria:\n\nPatients with:\n\n* Upper respiratory tract infection within the previous 28 days\n* Treatment with antibiotics within 4 weeks prior the study\n* Acute dyspnoea or hemoptysis\n* Chest pain or recent history of rib fracture or pneumothorax\n* Acute cardiovascular events in the previous 3 months\n* Any history or evidence of renal, gastrointestinal or hepatic disease\n* Any history and evidence of neuropsychiatric disease\n* Alcohol, drug abuse or any other condition associated with poor compliance\n* Breast feeding\n* Pregnancy\n* Other complications that hinder the completion of the tests\n* Unable to provide written informed consent'}, 'identificationModule': {'nctId': 'NCT01832961', 'acronym': 'AEFLUC', 'briefTitle': 'Acute Effects of a Flutter Device in COPD', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'Acute Effects of a Flutter Device on Airways Resistance in Chronic Obstructive Pulmonary Disease (COPD)', 'orgStudyIdInfo': {'id': '13/C0346'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'flutter valve exercises', 'description': '30 minutes of breathing exercises with flutter device', 'interventionNames': ['Device: Flutter valve exercises', 'Device: Flutter and bronchodilator exercises']}, {'type': 'SHAM_COMPARATOR', 'label': 'flutter-sham exercises', 'description': '30 minutes of breathing exercise with flutter-sham device', 'interventionNames': ['Device: Flutter Sham exercises', 'Device: Flutter and bronchodilator exercises']}], 'interventions': [{'name': 'Flutter valve exercises', 'type': 'DEVICE', 'otherNames': ['Breathing exercises with flutter device', 'Airway clearance technique'], 'description': '30 minutes of flutter exercises', 'armGroupLabels': ['flutter valve exercises']}, {'name': 'Flutter Sham exercises', 'type': 'DEVICE', 'otherNames': ['Breathing exercises with flutter-sham device', 'Airway clearance technique'], 'description': '30 minutes of flutter-sham exercises', 'armGroupLabels': ['flutter-sham exercises']}, {'name': 'Flutter and bronchodilator exercises', 'type': 'DEVICE', 'description': 'Flutter + bronchodilator exercises with an interval of 3 to 5 days', 'armGroupLabels': ['flutter valve exercises', 'flutter-sham exercises']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SW3 6LY', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Asthma Lab, Royal Brompton Hospital, National Heart and Lung Institute, Imperial College London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Omar Usmani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College London'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}