Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2026-01-02 @ 3:43 AM
Study NCT ID:
NCT03137992
Status:
COMPLETED
Last Update Posted:
2021-04-05
First Post:
2017-04-30
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Endpoint Bioequivalence Study of Test and Reference Inhalation Products in Patients With COPD With Device Robustness
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-02-18', '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': 'D000069447', 'term': 'Tiotropium Bromide'}], 'ancestors': [{'id': 'D012602', 'term': 'Scopolamine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'marklepore@lupin.com', 'phone': '(443) 740-9323', 'title': 'Dr. Mark Lepore', 'organization': 'Lupin Research Inc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'All AEs/SAEs were assessed through study completion, an average of 14 weeks for participants enrolled in only part 1 of the study and 26 weeks for participants enrolled in part 1 and part 2 of the study. AEs were recorded starting after the patient signed the informed consent form and assessed at each visit.', 'description': 'Adverse events are illnesses or signs/symptoms that appear or worsen during the testing of a drug whether o not considered related to the investigational product (synonyms = medicinal or pharmaceutical product, study medication, clinical trial materials, etc.) including side effects, injury, toxicity, or hypersensitivity reactions. AEs were captured during participant interviews during on-site and telephonic visits.', 'eventGroups': [{'id': 'EG000', 'title': 'Test Product (Lupin Tiotropium Bromide Inhalation Powder)', 'description': 'Single dose 18 mcg of test product (tiotropium bromide inhalation powder) for double blind portion.\n\nOnce daily administration of test product (tiotropium bromide inhalation powder), 18 mcg for open-label extension (device robustness).', 'otherNumAtRisk': 337, 'deathsNumAtRisk': 337, 'otherNumAffected': 0, 'seriousNumAtRisk': 337, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Reference Product (Spiriva®)', 'description': 'Single dose of reference product (Spiriva®) 18 mcg\n\nReference Product (Spiriva®): Reference product (Spiriva®) 18 mcg.', 'otherNumAtRisk': 343, 'deathsNumAtRisk': 343, 'otherNumAffected': 0, 'seriousNumAtRisk': 343, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Single dose of placebo inhalation powder\n\nPlacebo: Single dose of placebo inhalation powder administered by test and reference dry powder inhalers.', 'otherNumAtRisk': 329, 'deathsNumAtRisk': 329, 'otherNumAffected': 0, 'seriousNumAtRisk': 329, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Baseline Adjusted Mean Change in FEV1 AUC0-24h Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Product (Tiotropium Bromide Inhalation Powder)', 'description': 'Single dose 18 mcg of test product (tiotropium bromide inhalation powder), a long acting muscarinic receptor antagonist, for double blind portion.\n\nOnce daily administration of test product (tiotropium bromide inhalation powder), 18 mcg for open-label extension (device robustness).'}, {'id': 'OG001', 'title': 'Reference Product (Spiriva®)', 'description': 'Single dose of reference product (Spiriva®) 18 mcg\n\nReference Product (Spiriva®): Reference product (Spiriva®) 18 mcg.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5644', 'spread': '0.323', 'groupId': 'OG000'}, {'value': '2.7370', 'spread': '0.322', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squared Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.9369', 'ciLowerLimit': '0.834', 'ciUpperLimit': '1.047', 'estimateComment': "Fieller's formula was applied to calculate the 90% confidence interval (CI) for the Lupin Tiotropium and Spiriva Handihaler LS mean ratio.", 'groupDescription': 'A blinded interim analysis was performed after 241 subjects had been randomized with measurable AUC data, which estimated 238 patients would be needed to demonstrate BE with 90% power. Therefore, it was planned that approximately 378 patients would be randomized to allow for a potential 30% loss/withdrawal from the PP population.', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Bioequivalence was declared if the 90% CI was entirely contained within the bioequivalence interval, 0.80 to 1.25.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '0-24 hours after dosing on Day 1 of visits 2-4 over a period of approximately 6 weeks', 'description': 'To show clinical bioequivalence in the efficacy of the test product as a single dose versus reference product based on the baseline adjusted mean change in forced expiratory volume in the first second (FEV1) area under the curve from time zero to 24 hours post dose (AUC0-24h) on day 1 zero to 24 hours post-dose (AUC0-24h). Baseline was defined as the average of the FEV1 values recorded at approximately 30 minutes and 15 minutes before dosing with study medication.', 'unitOfMeasure': 'L*hour', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol population'}, {'type': 'PRIMARY', 'title': 'Difference in Baseline Adjusted FEV1 AUC0-24h for Comparison of Lupin Tiotropium Bromide Inhalation Powder (Test) and Spiriva (Reference) to Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '372', 'groupId': 'OG000'}, {'value': '372', 'groupId': 'OG001'}, {'value': '372', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Test Product (Tiotropium Bromide Inhalation Powder)', 'description': 'Single dose 18 mcg of test product (tiotropium bromide inhalation powder), a long acting muscarinic receptor antagonist, for double blind portion.\n\nOnce daily administration of test product (tiotropium bromide inhalation powder), 18 mcg for open-label extension (device robustness).'}, {'id': 'OG001', 'title': 'Reference Product (Spiriva®)', 'description': 'Single dose of reference product (Spiriva®) 18 mcg\n\nReference Product (Spiriva®): Reference product (Spiriva®) 18 mcg.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Single dose of placebo inhalation powder\n\nPlacebo: Single dose of placebo inhalation powder administered by test and reference dry powder inhalers.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.90', 'spread': '0.197', 'groupId': 'OG000'}, {'value': '3.03', 'spread': '0.196', 'groupId': 'OG001'}, {'value': '-0.40', 'spread': '0.199', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squared Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.29', 'ciLowerLimit': '2.9386', 'ciUpperLimit': '3.646', 'pValueComment': 'Efficacy of the Test (T) product was demonstrated if the T was shown to be statistically superior to Placebo (p\\<0.05 \\[two-tailed\\]).Outcome variable was Difference in Baseline adjusted FEV1 AUC0-24h.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.180', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model repeated measures analysis consisted of effects of treatment, period, and sequence.'}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Least Squared Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.43', 'ciLowerLimit': '3.0718', 'ciUpperLimit': '3.7797', 'pValueComment': 'Study sensitivity was demonstrated if the Reference (R) product was shown to be statistically superior to Placebo (P) (p \\<0.05 \\[two-tailed\\]). Outcome variable was Difference in Baseline adjusted FEV1 AUC0-24h.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.180', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed model repeated measures analysis consisted of effects of treatment, period, and sequence.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '0-24 hours after dosing on Day 1 of visits 2-4 over a period of approximately 6 weeks', 'description': 'This measure is to demonstrate that test product as a single dose and reference product are superior to placebo based on the baseline adjusted mean change in forced expiratory volume in the first second (FEV1) area under the curve from time zero to 24 hours post dose (AUC0-24h) on day 1 zero to 24 hours post-dose (AUC0-24h). Baseline was defined as the average of the FEV1 values recorded at approximately 30 minutes and 15 minutes before dosing with study medication.', 'unitOfMeasure': 'L*hour', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-To-Treat population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sequence A (T-R-P)', 'description': 'Participants received Lupin Tiotropium Bromide Inhalation Powder 18 mcg via LUPINHALER in Period 1 (2 inhalations from one capsule), followed by Spiriva Handihaler 18 mcg in Period 2 (2 inhalations from one capsule), followed by Placebo in period 3 (2 inhalations from one capsule). Select participants who completed Part 1 of the study participated in Part 2 (open-label extension). Subjects received Lupin Tiotropium Bromide Inhalation Powder 18 mcg via LUPINHALER once daily (2 inhalations from one capsule) for 72 days'}, {'id': 'FG001', 'title': 'Sequence B (R-P-T)', 'description': 'Participants received SPIRIVA Handihaler 18 mcg in Period 1 (2 inhalations from one capsule), followed by placebo in Period 2 (2 inhalations from one capsule), followed by Lupin Tiotropium Bromide Inhalation Powder 18 mcg via LUPINHALER in Period 3 (2 inhalations from one capsule). Select participants who completed Part 1 of the study participated in Part 2 (open-label extension). Subjects received Lupin Tiotropium Bromide Inhalation Powder 18 mcg via LUPINHALER once daily (2 inhalations from one capsule) for 72 days'}, {'id': 'FG002', 'title': 'Sequence C (P-T-R)', 'description': 'Participants received Placebo in Period 1 (2 inhalations from one capsule), followed by Lupin Tiotropium Bromide Inhalation Powder 18 mcg via LUPINHALER in Period 2 (2 inhalations from one capsule), followed by SPIRIVA Handihaler 18 mcg in Period 3 (2 inhalations from one capsule). Select participants who completed Part 1 of the study participated in Part 2 (open-label extension). Subjects received Lupin Tiotropium Bromide Inhalation Powder 18 mcg via LUPINHALER once daily (2 inhalations from one capsule) for 72 days'}, {'id': 'FG003', 'title': 'Sequence D (P-R-T)', 'description': 'Participants received Placebo in Period 1 (2 inhalations from one capsule), followed by SPIRIVA Handihaler 18 mcg in Period 2 (2 inhalations from one capsule), followed by Lupin Tiotropium Bromide Inhalation Powder 18 mcg via LUPINHALER in Period 3 (2 inhalations from one capsule). Select participants who completed Part 1 of the study participated in Part 2 (open-label extension). Subjects received Lupin Tiotropium Bromide Inhalation Powder 18 mcg via LUPINHALER once daily (2 inhalations from one capsule) for 72 days'}, {'id': 'FG004', 'title': 'Sequence E (T-P-R)', 'description': 'Participants received Lupin Tiotropium Bromide Inhalation Powder 18 mcg via LUPINHALER in Period 1 (2 inhalations from one capsule), followed by Placebo in Period 2 (2 inhalations from one capsule), followed by SPIRIVA Handihaler 18 mcg in Period 3 (2 inhalations from one capsule). Select participants who completed Part 1 of the study participated in Part 2 (open-label extension). Subjects received Lupin Tiotropium Bromide Inhalation Powder 18 mcg via LUPINHALER once daily (2 inhalations from one capsule) for 72 days'}, {'id': 'FG005', 'title': 'Sequence F (R-T-P)', 'description': 'Participants received SPIRIVA Handihaler 18 mcg in Period 1 (2 inhalations from one capsule), followed by Lupin Tiotropium Bromide Inhalation Powder 18 mcg via LUPINHALER in Period 2 (2 inhalations from one capsule), followed by Placebo in Period 3 (2 inhalations from one capsule). Select participants who completed Part 1 of the study participated in Part 2 (open-label extension). Subjects received Lupin Tiotropium Bromide Inhalation Powder 18 mcg via LUPINHALER once daily (2 inhalations from one capsule) for 72 days'}], 'periods': [{'title': 'Period 1 (Visit 2)', 'milestones': [{'type': 'STARTED', 'comment': 'Three of the 377 participants enrolled and randomized did not receive any treatment.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '63'}, {'groupId': 'FG003', 'numSubjects': '63'}, {'groupId': 'FG004', 'numSubjects': '62'}, {'groupId': 'FG005', 'numSubjects': '61'}]}, {'type': 'COMPLETED', 'comment': 'One subject randomized to Sequence A received treatment P in period 1 (visit 2)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '63'}, {'groupId': 'FG003', 'numSubjects': '63'}, {'groupId': 'FG004', 'numSubjects': '62'}, {'groupId': 'FG005', 'numSubjects': '61'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Washout Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '63'}, {'groupId': 'FG003', 'numSubjects': '63'}, {'groupId': 'FG004', 'numSubjects': '62'}, {'groupId': 'FG005', 'numSubjects': '61'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '59'}, {'groupId': 'FG002', 'numSubjects': '61'}, {'groupId': 'FG003', 'numSubjects': '63'}, {'groupId': 'FG004', 'numSubjects': '60'}, {'groupId': 'FG005', 'numSubjects': '59'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Principal Investigator Discretion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COPD Exacerbation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Subject Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Period 2 (Visit 3)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '59'}, {'groupId': 'FG002', 'numSubjects': '61'}, {'groupId': 'FG003', 'numSubjects': '63'}, {'groupId': 'FG004', 'numSubjects': '60'}, {'groupId': 'FG005', 'numSubjects': '59'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '58'}, {'groupId': 'FG003', 'numSubjects': '58'}, {'groupId': 'FG004', 'numSubjects': '56'}, {'groupId': 'FG005', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'COPD Exacerbation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Did not meet continuation criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Washout Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '58'}, {'groupId': 'FG003', 'numSubjects': '58'}, {'groupId': 'FG004', 'numSubjects': '56'}, {'groupId': 'FG005', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '58'}, {'groupId': 'FG003', 'numSubjects': '57'}, {'groupId': 'FG004', 'numSubjects': '53'}, {'groupId': 'FG005', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'COPD Exacerbation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Subject Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}, {'title': 'Period 3 (Visit 04)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '58'}, {'groupId': 'FG003', 'numSubjects': '57'}, {'groupId': 'FG004', 'numSubjects': '53'}, {'groupId': 'FG005', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '48'}, {'groupId': 'FG002', 'numSubjects': '55'}, {'groupId': 'FG003', 'numSubjects': '57'}, {'groupId': 'FG004', 'numSubjects': '50'}, {'groupId': 'FG005', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Did not meet continuation criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Part 2 (Open-label Extension)', 'milestones': [{'type': 'STARTED', 'comment': 'Part 2 of the study enrolled a subset of 125 (from select investigational centers) participants who had successfully completed Part 1 of the study and who met the continuation criteria.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '25'}, {'groupId': 'FG004', 'numSubjects': '18'}, {'groupId': 'FG005', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '24'}, {'groupId': 'FG004', 'numSubjects': '18'}, {'groupId': 'FG005', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COPD exacerbation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, 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Baseline was defined as the average of the FEV1 values recorded at approximately 30 minutes and 15 minutes before dosing with study medication.'}, {'measure': 'Difference in Baseline Adjusted FEV1 AUC0-24h for Comparison of Lupin Tiotropium Bromide Inhalation Powder (Test) and Spiriva (Reference) to Placebo', 'timeFrame': '0-24 hours after dosing on Day 1 of visits 2-4 over a period of approximately 6 weeks', 'description': 'This measure is to demonstrate that test product as a single dose and reference product are superior to placebo based on the baseline adjusted mean change in forced expiratory volume in the first second (FEV1) area under the curve from time zero to 24 hours post dose (AUC0-24h) on day 1 zero to 24 hours post-dose (AUC0-24h). Baseline was defined as the average of the FEV1 values recorded at approximately 30 minutes and 15 minutes before dosing with study medication.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COPD'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to show bioequivalence of test product to reference product based on baseline-adjusted forced expiratory volume in one second (FEV1).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and non-pregnant female subjects (40 years of age and older).\n* Patients with diagnosis of COPD according to the GOLD guidelines.\n* Post-bronchodilator FEV1 \\<80% of the predicted value at the screening visit.\n* Post-bronchodilator 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