Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-26 @ 12:57 AM
Study NCT ID:
NCT04606394
Status:
COMPLETED
Last Update Posted:
2023-05-08
First Post:
2020-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Peak Inspiratory Flow and Dry Powder Inhaler Performance in COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-02-09', 'type': 'ACTUAL'}}}}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000420', 'term': 'Albuterol'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'garytferguson@msn.com', 'phone': '248-514-6063', 'title': 'Gary T Ferguson, M.D.', 'organization': 'PRISM'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'No primary information was available to derive power calculations to estimate the number of subjects needed to test the study hypothesis'}}, 'adverseEventsModule': {'timeFrame': '6 weeks - from consent to 1 week post completion of study', 'description': 'No difference in definitions', 'eventGroups': [{'id': 'EG000', 'title': 'Open Label Treatment', 'description': 'All subjects receive Trelegy and Ventolin for 2 weeks\n\nTrelegy Ellipta 100/62.5/25Mcg Inh 30D: Administration of Trelegy in all patients\n\nVentolin 90Mcg/Actuation Inhalation Aerosol: 2 hours after the administration of Trelegy, administer Ventolin in all patients', 'otherNumAtRisk': 45, 'deathsNumAtRisk': 45, 'otherNumAffected': 0, 'seriousNumAtRisk': 45, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'DPI Responder Analysis in Patients With Suboptimal PIF (<60 L/Min)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}, {'units': 'Subjet test days', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Suboptimal PIF', 'description': 'Subject with PIF \\< 60 L/min at baseline'}, {'id': 'OG001', 'title': 'Normal PIF', 'description': 'Subjects with PIF \\> 60 L/min at baseline'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.33', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1', 'groupDescription': 'Data outcome reported was the number and percentage of subject test days with DPI Failure in subjects in suboptimal PIF (\\<60 L/min) versus normal PIF subjects. Statistical analysis performed was a comparison between rates of DPI Failure in the 2 groups.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '2 weeks', 'description': 'Outcome = the number of subject test days (2 test days per subject) meeting responder criteria defined as:\n\nDPI Responder - a positive (\\>50 ml) peak FEV1 response 2 hours after Trelegy Ellipta® DPI with a negative (\\<50mL) peak FEV1 response 30 minutes after Ventolin® pMDI (2.5 hours post Trelegy) DPI Partial Responder a positive (\\>50 ml) peak FEV1 response 2 hours after Trelegy® Ellipta DPI with a positive (\\>50 ml) peak FEV1 response 30 minutes after Ventolin® pMDI (2.5 hours post Trelegy) DPI Failure - a negative (\\<50mL) peak FEV1 response 2 hours after Trelegy Ellipta® DPI with a positive (\\>50 ml) peak FEV1 response 30 minutes after Ventolin® pMDI (2.5 hours post Trelegy) Irreversible - a negative (\\<50mL) peak FEV1 response 2 hours after Trelegy Ellipta® DPI with a negative (\\<50mL) peak FEV1 response 30 minutes after Ventolin® pMDI (2.5 hours post Trelegy)', 'unitOfMeasure': 'Number of subject test days', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Subjet test days', 'denomUnitsSelected': 'Subjet test days', 'populationDescription': 'Number of subject test days (2 per subject) with DPI Failure based on baseline PIF \\<60 L/min or \\>60 L/min'}, {'type': 'SECONDARY', 'title': 'DPI Responder Analysis in Patients With Reduced PIF (<45 L/Min)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}, {'units': 'Number of sub ject test days', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reduced PIF', 'description': 'PIF \\<45 L/min at baseline'}, {'id': 'OG001', 'title': 'Normal PIF', 'description': 'PIF \\> 45 L/min at baseline'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1', 'groupDescription': 'Data outcome reported was the number and percentage of subject test days with DPI Failure in subjects in suboptimal PIF (\\<60 L/min) versus normal PIF subjects. Statistical analysis performed was a comparison between rates of DPI Failure in the 2 groups.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '2 weeks', 'description': 'Outcome = the number of subject test days (2 test days per subject) meeting responder criteria defined as:\n\nDPI Responder - a positive (\\>50 ml) peak FEV1 response 2 hours after Trelegy Ellipta® DPI with a negative (\\<50mL) peak FEV1 response 30 minutes after Ventolin® pMDI (2.5 hours post Trelegy) DPI Partial Responder a positive (\\>50 ml) peak FEV1 response 2 hours after Trelegy® Ellipta DPI with a positive (\\>50 ml) peak FEV1 response 30 minutes after Ventolin® pMDI (2.5 hours post Trelegy) DPI Failure - a negative (\\<50mL) peak FEV1 response 2 hours after Trelegy Ellipta® DPI with a positive (\\>50 ml) peak FEV1 response 30 minutes after Ventolin® pMDI (2.5 hours post Trelegy) Irreversible - a negative (\\<50mL) peak FEV1 response 2 hours after Trelegy Ellipta® DPI with a negative (\\<50mL) peak FEV1 response 30 minutes after Ventolin® pMDI (2.5 hours post Trelegy)', 'unitOfMeasure': 'Number of subject test days', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of sub ject test days', 'denomUnitsSelected': 'Number of sub ject test days', 'populationDescription': 'Number of subject test days (2 per subject) with DPI Failure based on baseline PIF \\<45 L/min or \\>45 L/min'}, {'type': 'SECONDARY', 'title': 'PIF Measurement Techniques', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Ellipta PIF Standing', 'description': 'Performance of PIF using Ellipta instructions while standing'}, {'id': 'OG001', 'title': 'Ellipta PIF Sitting', 'description': 'Performance of PIF using Ellipta instructions while sitting'}, {'id': 'OG002', 'title': 'Instructed PIF', 'description': 'Pif measured with maximal PIF instrucitons only'}, {'id': 'OG003', 'title': 'Encouraged PIF', 'description': 'Pif measured while instructed and encouraged for maximal effort'}, {'id': 'OG004', 'title': 'Spiro PIF', 'description': 'PIF measured with maximal inspiratory effort/flow loop during spirometry'}], 'classes': [{'categories': [{'measurements': [{'value': '52', 'spread': '17', 'groupId': 'OG000'}, {'value': '53', 'spread': '25', 'groupId': 'OG001'}, {'value': '70', 'spread': '18', 'groupId': 'OG002'}, {'value': '74', 'spread': '18', 'groupId': 'OG003'}, {'value': '137', 'spread': '67', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline on day of testing', 'description': 'PIF value (L/min) based on different PIF measurement techniques', 'unitOfMeasure': 'L/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Trelegy Ellipta Open Label Treatment', 'description': 'All subjects receive Trelegy and Ventolin for 2 weeks\n\nTrelegy Ellipta 100/62.5/25Mcg Inh 30D: Administration of Trelegy in all patients\n\nVentolin 90Mcg/Actuation Inhalation Aerosol: 2 hours after the administration of Trelegy, administer Ventolin in all patients'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '45 subjects recruited/consented. 12 failed entry criteria during screening and 3 withdrew consent during screening for non-medical reasons. 30 subjects met entry criteria per protocol and started/completed the study.', 'groupId': 'FG000', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Exclusion criteria screen failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}]}]}], 'recruitmentDetails': 'Severe/very severe COPD patients in stable condition stratified to insure that at least 12 of 30 subjects had a suboptimal peak inspiratory flow (PIF \\<60L/min)', 'preAssignmentDetails': 'Enrollment, run-in on current maintenance therapy followed by testing, conversion of maintenance therapy to Trelegy Ellipta therapy for 2 weeks followed by testing'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Open Label Treatment', 'description': 'All subjects receive Trelegy and Ventolin for 2 weeks\n\nTrelegy Ellipta 100/62.5/25Mcg Inh 30D: Administration of Trelegy in all patients\n\nVentolin 90Mcg/Actuation Inhalation Aerosol: 2 hours after the administration of Trelegy, administer Ventolin in all patients'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '66', 'spread': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '17', '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': 'Using triple therapy at baseline', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'CAT score ≥10', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'COPD Assessment TesT (CAT) - Quality of Life Health Assessment Tool - range from 0-40, with a higher number identifying more severe symptoms. CAT score of 10 or higher used to define a symptomatic COPD patient.', 'unitOfMeasure': 'Participants'}, {'title': 'CAT score ≥15', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'COPD Assessment TesT (CAT) - Quality of Life Health Assessment Tool - range from 0-40, with a higher number identifying more severe symptoms. CAT score of 15 or higher used to define a very symptomatic COPD patient.', 'unitOfMeasure': 'Participants'}, {'title': 'History of 2 moderate/1 severe exacerbation', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'History of severe exacearbtion', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-04-03', 'size': 154026, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_001.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2023-04-03T20:37', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open label comparative design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-04', 'studyFirstSubmitDate': '2020-10-19', 'resultsFirstSubmitDate': '2023-01-16', 'studyFirstSubmitQcDate': '2020-10-22', 'lastUpdatePostDateStruct': {'date': '2023-05-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-05-04', 'studyFirstPostDateStruct': {'date': '2020-10-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DPI Responder Analysis in Patients With Suboptimal PIF (<60 L/Min)', 'timeFrame': '2 weeks', 'description': 'Outcome = the number of subject test days (2 test days per subject) meeting responder criteria defined as:\n\nDPI Responder - a positive (\\>50 ml) peak FEV1 response 2 hours after Trelegy Ellipta® DPI with a negative (\\<50mL) peak FEV1 response 30 minutes after Ventolin® pMDI (2.5 hours post Trelegy) DPI Partial Responder a positive (\\>50 ml) peak FEV1 response 2 hours after Trelegy® Ellipta DPI with a positive (\\>50 ml) peak FEV1 response 30 minutes after Ventolin® pMDI (2.5 hours post Trelegy) DPI Failure - a negative (\\<50mL) peak FEV1 response 2 hours after Trelegy Ellipta® DPI with a positive (\\>50 ml) peak FEV1 response 30 minutes after Ventolin® pMDI (2.5 hours post Trelegy) Irreversible - a negative (\\<50mL) peak FEV1 response 2 hours after Trelegy Ellipta® DPI with a negative (\\<50mL) peak FEV1 response 30 minutes after Ventolin® pMDI (2.5 hours post Trelegy)'}], 'secondaryOutcomes': [{'measure': 'DPI Responder Analysis in Patients With Reduced PIF (<45 L/Min)', 'timeFrame': '2 weeks', 'description': 'Outcome = the number of subject test days (2 test days per subject) meeting responder criteria defined as:\n\nDPI Responder - a positive (\\>50 ml) peak FEV1 response 2 hours after Trelegy Ellipta® DPI with a negative (\\<50mL) peak FEV1 response 30 minutes after Ventolin® pMDI (2.5 hours post Trelegy) DPI Partial Responder a positive (\\>50 ml) peak FEV1 response 2 hours after Trelegy® Ellipta DPI with a positive (\\>50 ml) peak FEV1 response 30 minutes after Ventolin® pMDI (2.5 hours post Trelegy) DPI Failure - a negative (\\<50mL) peak FEV1 response 2 hours after Trelegy Ellipta® DPI with a positive (\\>50 ml) peak FEV1 response 30 minutes after Ventolin® pMDI (2.5 hours post Trelegy) Irreversible - a negative (\\<50mL) peak FEV1 response 2 hours after Trelegy Ellipta® DPI with a negative (\\<50mL) peak FEV1 response 30 minutes after Ventolin® pMDI (2.5 hours post Trelegy)'}, {'measure': 'PIF Measurement Techniques', 'timeFrame': 'Baseline on day of testing', 'description': 'PIF value (L/min) based on different PIF measurement techniques'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['DPI', 'PIF', 'FEV1'], 'conditions': ['COPD']}, 'referencesModule': {'references': [{'pmid': '40998461', 'type': 'DERIVED', 'citation': 'Perugini V, Rhee CK, Moon JY, Pei Yee T, Ra SW, Pirina P, Yoo KH, Navarrete BA, Gouder C, Pacheco A, Navarro-Rolon A, Harlander M, Lapperre T, Loh SCH, Fole D, Naval E, Palacios PJR, Miravitlles M, Usmani O. Assessment of peak inspiratory flow in patients with chronic obstructive pulmonary disease: a multicentre, observational, prospective, real-life study. BMJ Open Respir Res. 2025 Sep 25;12(1):e002408. doi: 10.1136/bmjresp-2024-002408.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine whether PIF is clinically important when using the Ellipta DPI device. In addition, the study will validate the best/most clinically appropriate way to perform a PIF maneuver, to determine the testing capabilities of the preferred PIF maneuver and to relate this PIF measurement to meaningful clinical outcomes in COPD patients', 'detailedDescription': 'Study Design and Methods Rationale\n\n* The expected FEV1 response to a bronchodilator is uncertain as multiple factors influence this measure, including severity of disease, day to day variability, varying reversibility in COPD patients, the delivery of the drug to a patient and the effectiveness of the medication delivered. Thus, the measurement of an acute bronchodilator response after delivering a long acting bronchodilator may not identify whether a medication has been effectively delivered to a patient.\n* However, if a long acting bronchodilator has not been effectively delivered to the lung, then subsequent delivery of a short acting bronchodilator should produce a significant additional bronchodilator response. On the other hand, if a long acting bronchodilator has been effectively delivered to the lung, then subsequent delivery of a short acting bronchodilator should not produce any further significant bronchodilation.\n* Based on this rationale, comparison of the acute bronchodilator response to a short acting bronchodilator after receiving a long acting should identify whether drug delivery is ineffective in a selected patient population, irrespective of baseline FEV1 and of any partial response to the long acting bronchodilator. Comparison of the short acting bronchodilator measurement between patient groups with differing PIF thresholds should identify whether PIF has an impact of drug delivery of a long acting bronchodilator via a DPI.\n* Open label design comparing the acute bronchodilator response after delivery of a long acting bronchodilator via Ellipta DPI in patients with normal, suboptimal and minimal PIF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* smoking history \\>10 pack years\n* pre-bronchodilator FEV1 \\<60% predicted\n* post-bronchodilator FEV1/FVC \\<70%\n* female participants are eligible to participate if they are not pregnant, not breastfeeding, and at least one of the following conditions applies:\n* not a woman of childbearing potential OR\n* agree to follow the contraceptive guidance during the treatment period and until the safety follow-up contact after the last dose of study treatment\n* stratification requiring at least 1/3 of patients having a PIF of \\< 60L/min (AM pre-dose based on using the level 2 InCheck Dial resistance setting with a sharp maximal effort starting after exhaling fully)\n\nExclusion Criteria:\n\n* any subject with unstable disease, including\n* COPD exacerbation in the last 6 weeks\n* upper respiratory tract in in the last 4 weeks\n* COPD or upper respiratory tract infection during run-in (subjects may be re-screened x 1 when stable after an acute event)\n* pulmonary disease other than COPD\n* any lung resection\n* unstable cardiac conditions (at the discretion of the investigator)\n* other unstable medical conditions (at the discretion of the investigator)'}, 'identificationModule': {'nctId': 'NCT04606394', 'briefTitle': 'Peak Inspiratory Flow and Dry Powder Inhaler Performance in COPD', 'organization': {'class': 'OTHER', 'fullName': 'Pulmonary Research Institute of Southeast Michigan'}, 'officialTitle': 'Peak Inspiratory Flow (PIF) and Dry Powder Inhaler (DPI) Performance in Chronic Obstructive Pulmonary Disease (COPD)', 'orgStudyIdInfo': {'id': '001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Open label treatment', 'description': 'All subjects receive Trelegy and Ventolin for 2 weeks', 'interventionNames': ['Drug: Trelegy Ellipta 100/62.5/25Mcg Inh 30D', 'Drug: Ventolin 90Mcg/Actuation Inhalation Aerosol']}], 'interventions': [{'name': 'Trelegy Ellipta 100/62.5/25Mcg Inh 30D', 'type': 'DRUG', 'otherNames': ['DPI Delivery'], 'description': 'Administration of Trelegy in all patients', 'armGroupLabels': ['Open label treatment']}, {'name': 'Ventolin 90Mcg/Actuation Inhalation Aerosol', 'type': 'DRUG', 'otherNames': ['pMDI Delivery'], 'description': '2 hours after the administration of Trelegy, administer Ventolin in all patients', 'armGroupLabels': ['Open label treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48336', 'city': 'Farmington Hills', 'state': 'Michigan', 'country': 'United States', 'facility': 'Pulmonary Research Institute of Southeast Michigan', 'geoPoint': {'lat': 42.48531, 'lon': -83.37716}}], 'overallOfficials': [{'name': 'Gary T Ferguson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pulmonary Research Institute of Southeast Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pulmonary Research Institute of Southeast Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}