Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2026-02-06 @ 5:24 AM
Study NCT ID:
NCT02454959
Status:
COMPLETED
Last Update Posted:
2017-04-19
First Post:
2015-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Crossover Study to Assess the Efficacy of PT003 With and Without a Valved Holding Chamber in Subjects With Moderate to Severe COPD
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': 'creisner@pearltherapeutics.com', 'phone': '650-305-2600', 'title': 'Colin Reisner, MD, FCCP, FAAAAI', 'organization': 'Pearl Therapeutics, Inc.'}, 'certainAgreement': {'otherDetails': "Drafts of any and all publications or presentations of this study must be submitted at least 30 days prior to submission for publication or presentation to Pearl Therapeutics for review, approval, and to ensure consistency. Pearl Therapeutics has the right to request appropriate modification to correct facts and to represent it's opinions, or the opinions of the publication committee, if these differ with the proposed publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.', 'description': 'Any Adverse Events reported as starting during a Washout Period were assigned to the last randomized treatment received including those occurring during a Washout Period or the Follow-up Period. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'GFF MDI (PT003) With Aerochamber', 'description': 'Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID with Aerochamber Plus Valved Holding Chamber', 'otherNumAtRisk': 74, 'otherNumAffected': 3, 'seriousNumAtRisk': 74, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'GFF MDI (PT003) Without Aerochamber', 'description': 'Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID without Aerochamber Plus Valved Holding Chamber', 'otherNumAtRisk': 78, 'otherNumAffected': 8, 'seriousNumAtRisk': 78, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Blood potassium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vessel puncture site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory Distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Curve for Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) From 0 to 12 Hours (AUC0-12) on Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GFF MDI (PT003) With Aerochamber', 'description': 'Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID with Aerochamber Plus Valved Holding Chamber'}, {'id': 'OG001', 'title': 'GFF MDI (PT003) Without Aerochamber', 'description': 'Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID without Aerochamber Plus Valved Holding Chamber'}], 'classes': [{'categories': [{'measurements': [{'value': '1.538', 'spread': '0.0228', 'groupId': 'OG000'}, {'value': '1.516', 'spread': '0.0227', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '7 days of treatment', 'description': 'AUC0-12 was calculated using the trapezoidal rule based on FEV1 assessments at pre-dose, and 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 10 hours, 11.5 hours, and 12 hours post-dosing of study drug. Primary Outcome was calculated using the trapezoidal rule and was modeled conditionally on baseline FEV1.', 'unitOfMeasure': 'Liter', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary analysis used the Modified-Intent-to-Treat (MITT) Population.'}, {'type': 'SECONDARY', 'title': 'AUC0-12 on Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GFF MDI (PT003) With Aerochamber', 'description': 'Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID with Aerochamber Plus Valved Holding Chamber'}, {'id': 'OG001', 'title': 'GFF MDI (PT003) Without Aerochamber', 'description': 'Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID without Aerochamber Plus Valved Holding Chamber'}], 'classes': [{'categories': [{'measurements': [{'value': '128.00', 'spread': '85.63', 'groupId': 'OG000'}, {'value': '111.39', 'spread': '63.54', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 8', 'description': 'Pharmacokinetic Parameter AUC0-12 of Glycopyrronium by Treatment on Day 8', 'unitOfMeasure': 'h*pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population'}, {'type': 'SECONDARY', 'title': 'AUC0-12 on Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GFF MDI (PT003) With Aerochamber', 'description': 'Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID with Aerochamber Plus Valved Holding Chamber'}, {'id': 'OG001', 'title': 'GFF MDI (PT003) Without Aerochamber', 'description': 'Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID without Aerochamber Plus Valved Holding Chamber'}], 'classes': [{'categories': [{'measurements': [{'value': '75.46', 'spread': '43.29', 'groupId': 'OG000'}, {'value': '78.49', 'spread': '39.17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 8', 'description': 'Pharmacokinetic Parameter AUC0-12 of Formoterol by Treatment on Day 8', 'unitOfMeasure': 'h*pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population'}, {'type': 'SECONDARY', 'title': 'Cmax on Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GFF MDI (PT003) With Aerochamber', 'description': 'Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID with Aerochamber Plus Valved Holding Chamber'}, {'id': 'OG001', 'title': 'GFF MDI (PT003) Without Aerochamber', 'description': 'Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID without Aerochamber Plus Valved Holding Chamber'}], 'classes': [{'categories': [{'measurements': [{'value': '34.03', 'spread': '21.87', 'groupId': 'OG000'}, {'value': '26.55', 'spread': '15.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 8', 'description': 'Pharmacokinetic Parameter Cmax of Glycopyrronium by Treatment on Day 8', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population'}, {'type': 'SECONDARY', 'title': 'Cmax on Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GFF MDI (PT003) With Aerochamber', 'description': 'Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID with Aerochamber Plus Valved Holding Chamber'}, {'id': 'OG001', 'title': 'GFF MDI (PT003) Without Aerochamber', 'description': 'Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID without Aerochamber Plus Valved Holding Chamber'}], 'classes': [{'categories': [{'measurements': [{'value': '12.53', 'spread': '5.88', 'groupId': 'OG000'}, {'value': '13.07', 'spread': '7.50', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 8', 'description': 'Pharmacokinetic Parameter Cmax of Formoterol by Treatment on Day 8', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population'}, {'type': 'SECONDARY', 'title': 'Tmax on Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GFF MDI (PT003) With Aerochamber', 'description': 'Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID with Aerochamber Plus Valved Holding Chamber'}, {'id': 'OG001', 'title': 'GFF MDI (PT003) Without Aerochamber', 'description': 'Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID without Aerochamber Plus Valved Holding Chamber'}], 'classes': [{'categories': [{'measurements': [{'value': '0.10', 'spread': '21.87', 'groupId': 'OG000', 'lowerLimit': '0.03', 'upperLimit': '10.02'}, {'value': '0.12', 'spread': '15.11', 'groupId': 'OG001', 'lowerLimit': '0.03', 'upperLimit': '8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 8', 'description': 'Pharmacokinetic Parameter tmax of Glycopyrronium by Treatment on Day 8', 'unitOfMeasure': 'h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population'}, {'type': 'SECONDARY', 'title': 'Tmax on Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GFF MDI (PT003) With Aerochamber', 'description': 'Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID with Aerochamber Plus Valved Holding Chamber'}, {'id': 'OG001', 'title': 'GFF MDI (PT003) Without Aerochamber', 'description': 'Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID without Aerochamber Plus Valved Holding Chamber'}], 'classes': [{'categories': [{'measurements': [{'value': '0.33', 'spread': '21.87', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10.02'}, {'value': '0.37', 'spread': '15.11', 'groupId': 'OG001', 'lowerLimit': '0.37', 'upperLimit': '10.17'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 8', 'description': 'Pharmacokinetic Parameter tmax of Formoterol by Treatment on Day 8', 'unitOfMeasure': 'h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Overall Study', 'description': 'All Randomized Patients'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}]}, {'type': 'GFF MDI (PT003) With Aerochamber', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}]}, {'type': 'GFF MDI (PT003) Without Aerochamber', 'achievements': [{'groupId': 'FG000', 'numSubjects': '77'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Protocol-Specified Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'This is a randomized, 2-period, open-label, chronic dosing (7 days), cross-over study conducted at 8 sites in the US.', 'preAssignmentDetails': 'Subject received one week of study treatment for each of the treatment periods, separated by a washout period of 7-14 days between treatments. Intent-to-treat (ITT) Population is used for Participant Flow. By-sequence tabulations of the data were not pre-specified.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'MITT Population', 'description': 'The Modified ITT (MITT) Population is a subset of the ITT Population including subjects who received treatment and had post dose efficacy data from both Treatment Periods. Data judged to be impacted by major protocol deviations were determined prior to unblinding and excluded. Statistical tabulations and analyses are by randomized treatment, but data obtained after subjects received an incorrect treatment have been excluded from the affected periods.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.5', 'spread': '8.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Modified-Intent-to-Treat (MITT) Population is a subset of the Intent-to-Treat (ITT) Population including subjects who received treatment and had post-treatment efficacy data for both treatment periods and is used for the baseline characteristics.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-03-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-07', 'studyFirstSubmitDate': '2015-05-13', 'resultsFirstSubmitDate': '2017-03-07', 'studyFirstSubmitQcDate': '2015-05-21', 'lastUpdatePostDateStruct': {'date': '2017-04-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-07', 'studyFirstPostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Curve for Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) From 0 to 12 Hours (AUC0-12) on Day 8', 'timeFrame': '7 days of treatment', 'description': 'AUC0-12 was calculated using the trapezoidal rule based on FEV1 assessments at pre-dose, and 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 10 hours, 11.5 hours, and 12 hours post-dosing of study drug. Primary Outcome was calculated using the trapezoidal rule and was modeled conditionally on baseline FEV1.'}], 'secondaryOutcomes': [{'measure': 'AUC0-12 on Day 8', 'timeFrame': 'Day 8', 'description': 'Pharmacokinetic Parameter AUC0-12 of Glycopyrronium by Treatment on Day 8'}, {'measure': 'AUC0-12 on Day 8', 'timeFrame': 'Day 8', 'description': 'Pharmacokinetic Parameter AUC0-12 of Formoterol by Treatment on Day 8'}, {'measure': 'Cmax on Day 8', 'timeFrame': 'Day 8', 'description': 'Pharmacokinetic Parameter Cmax of Glycopyrronium by Treatment on Day 8'}, {'measure': 'Cmax on Day 8', 'timeFrame': 'Day 8', 'description': 'Pharmacokinetic Parameter Cmax of Formoterol by Treatment on Day 8'}, {'measure': 'Tmax on Day 8', 'timeFrame': 'Day 8', 'description': 'Pharmacokinetic Parameter tmax of Glycopyrronium by Treatment on Day 8'}, {'measure': 'Tmax on Day 8', 'timeFrame': 'Day 8', 'description': 'Pharmacokinetic Parameter tmax of Formoterol by Treatment on Day 8'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['COPD']}, 'descriptionModule': {'briefSummary': 'This is a Randomized, Phase III, Two-period, Open-label, Chronic-dosing (7 Days), Multi-center, Crossover Study to Assess the Efficacy of PT003 in Subjects with Moderate to Severe COPD with and without a Valved Holding Chamber.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* At least 40 years of age and no older than 80 at Screening\n* Women of non-child bearing potential or negative serum pregnancy test at Screening, and agrees to acceptable contraceptive methods used consistently and correctly Screening until 14 days after final visit.\n* Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS)\n* Current or former smokers with a history of at least 10 pack-years of cigarette smoking\n* Pre- and post-bronchodilator FEV1/FVC ratio of \\<0.70\n* Post-bronchodilator FEV1 must be \\<80% predicted normal value, calculated using NHANES III reference equations, and the measured FEV1 must also be ≥30% of predicted normal value.\n\nExclusion Criteria:\n\n* Significant diseases other than COPD, i.e., disease or condition which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study.\n* Women who are pregnant or lactating or women of childbearing potential who are not using an acceptable method of contraception.\n* Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma.\n* Subjects who have been hospitalized due to poorly controlled COPD within 3 months prior to Screening or during the Screening Period.\n* Subjects who have poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to Screening or during the Screening Period.\n* Subjects who have clinically significant uncontrolled hypertension.\n* Subjects who have cancer that has not been in complete remission for at least five years.\n* Subjects with abnormal liver function tests defined as AST, ALT, or total bilirubin ≥1.5 times upper limit of normal at Screening and on repeat testing.\n* Subjects with a diagnosis of angle closure glaucoma will be excluded, regardless of whether or not they have been treated. Subjects with a diagnosis of open angle glaucoma who have intraocular pressure controlled with medication(s) are eligible.\n* Subjects with symptomatic prostatic hypertrophy that is clinically significant in the opinion of the Investigator. Subjects with a trans-urethral resection of prostate (TURP) or full resection of the prostate within 6 months prior to Screening are excluded from the study.\n* Subjects with bladder neck obstruction or urinary retention that is clinically significant in the opinion of the Investigator."}, 'identificationModule': {'nctId': 'NCT02454959', 'briefTitle': 'Crossover Study to Assess the Efficacy of PT003 With and Without a Valved Holding Chamber in Subjects With Moderate to Severe COPD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pearl Therapeutics, Inc.'}, 'officialTitle': 'A Randomized, Phase III, Two-period, Open-label, Chronic-dosing (7 Days), Multicenter, Crossover Study to Assess the Efficacy, Safety and Pharmacokinetics of PT003 in Subjects With Moderate to Very Severe COPD With and Without a Valved Holding Chamber', 'orgStudyIdInfo': {'id': 'PT003013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GFF MDI (PT003) with Aerochamber', 'description': 'Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) with Aerochamber Plus Valved Holding Chamber', 'interventionNames': ['Device: GFF MDI (PT003) with Aerochamber']}, {'type': 'EXPERIMENTAL', 'label': 'GFF MDI (PT003) without Aerochamber', 'description': 'Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) without Aerochamber Plus Valved Holding Chamber', 'interventionNames': ['Device: GFF MDI (PT003) without Aerochamber']}], 'interventions': [{'name': 'GFF MDI (PT003) with Aerochamber', 'type': 'DEVICE', 'description': 'Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) with Aerochamber Plus Valved Holding Chamber', 'armGroupLabels': ['GFF MDI (PT003) with Aerochamber']}, {'name': 'GFF MDI (PT003) without Aerochamber', 'type': 'DEVICE', 'description': 'Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) without Aerochamber Plus Valved Holding Chamber', 'armGroupLabels': ['GFF MDI (PT003) without Aerochamber']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Pearl Investigative Site', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Pearl Investigative Site', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'city': 'Winter Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Pearl Investigative Site', 'geoPoint': {'lat': 28.6, 'lon': -81.33924}}, {'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Pearl Investigative Site', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Pearl Investigative Site', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'city': 'Gaffney', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Pearl Investigative Site', 'geoPoint': {'lat': 35.07179, 'lon': -81.64982}}], 'overallOfficials': [{'name': 'Colin Reisner', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pearl Therapeutics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pearl Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}