Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-29 @ 9:19 PM
Study NCT ID:
NCT01772368
Status:
COMPLETED
Last Update Posted:
2017-06-12
First Post:
2013-01-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dose Ranging Study of the Salmeterol Component of Fluticasone /Salmeterol Spiromax Compared to Fluticasone Spiromax and Advair Diskus in Asthma Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068298', 'term': 'Fluticasone'}, {'id': 'D000068299', 'term': 'Salmeterol Xinafoate'}, {'id': 'D000068297', 'term': 'Fluticasone-Salmeterol Drug Combination'}, {'id': 'D000420', 'term': 'Albuterol'}, {'id': 'D017265', 'term': 'Procaterol'}], 'ancestors': [{'id': 'D000730', 'term': 'Androstadienes'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'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'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D006912', 'term': 'Hydroxyquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '1-215-591-3000', 'title': 'Director, Clinical Research', 'organization': 'Teva Branded Pharmaceutical Products, R&D Inc.'}, 'certainAgreement': {'otherDetails': "Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1 to Day 35', 'eventGroups': [{'id': 'EG000', 'title': 'Fp MDPI 100 mcg', 'description': 'Subjects inhaled a single dose of 100 mcg fluticasone propionate.', 'otherNumAtRisk': 67, 'deathsNumAtRisk': 67, 'otherNumAffected': 0, 'seriousNumAtRisk': 67, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'FS MDPI 100/6.25 mcg', 'description': 'Subjects inhaled a single dose of 100 mcg fluticasone propionate and 6.25 mcg salmeterol xinafoate.', 'otherNumAtRisk': 68, 'deathsNumAtRisk': 68, 'otherNumAffected': 0, 'seriousNumAtRisk': 68, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'FS MDPI 100/12.5mcg', 'description': 'Subjects inhaled a single dose of 100 mcg fluticasone propionate and 12.5 mcg salmeterol xinafoate.', 'otherNumAtRisk': 69, 'deathsNumAtRisk': 69, 'otherNumAffected': 0, 'seriousNumAtRisk': 69, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'FS MDPI 100/25 mcg', 'description': 'Subjects inhaled a single dose of 100 mcg fluticasone propionate and 25 mcg salmeterol xinafoate.', 'otherNumAtRisk': 67, 'deathsNumAtRisk': 67, 'otherNumAffected': 0, 'seriousNumAtRisk': 67, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'FS MDPI 100/50 mcg', 'description': 'Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate.', 'otherNumAtRisk': 68, 'deathsNumAtRisk': 68, 'otherNumAffected': 0, 'seriousNumAtRisk': 68, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Advair Diskus 100/50 mcg', 'description': 'Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate. This arm is the only arm which is open-label because the inhaler device was different than the MDPI used in the other treatment arms.', 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 0, 'seriousNumAtRisk': 66, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Fp MDPI 50 mcg X 2 BID', 'description': "Patients used 2 inhalations of Fp MDPI 50 mcg (100 mcg total dose) twice daily during the 'washout' between treatment periods, so adverse events during this treatment were assigned to Fp MDPI 50 mcg.", 'otherNumAtRisk': 72, 'deathsNumAtRisk': 72, 'otherNumAffected': 4, 'seriousNumAtRisk': 72, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 72, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Standardized Baseline-Adjusted Area Under the Curve For Forced Expiratory Volume In 1 Second Over 12 Hours Post-dose (FEV1 AUC0-12)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}, {'value': '68', 'groupId': 'OG004'}, {'value': '66', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Fp MDPI 100 mcg', 'description': 'Subjects inhaled a single dose of 100 mcg fluticasone propionate.'}, {'id': 'OG001', 'title': 'FS MDPI 100/6.25 mcg', 'description': 'Subjects inhaled a single dose of 100 mcg fluticasone propionate and 6.25 mcg salmeterol xinafoate.'}, {'id': 'OG002', 'title': 'FS MDPI 100/12.5mcg', 'description': 'Subjects inhaled a single dose of 100 mcg fluticasone propionate and 12.5 mcg salmeterol xinafoate.'}, {'id': 'OG003', 'title': 'FS MDPI 100/25 mcg', 'description': 'Subjects inhaled a single dose of 100 mcg fluticasone propionate and 25 mcg salmeterol xinafoate.'}, {'id': 'OG004', 'title': 'FS MDPI 100/50 mcg', 'description': 'Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate.'}, {'id': 'OG005', 'title': 'Advair Diskus 100/50 mcg', 'description': 'Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate. This arm is the only arm which is open-label because the inhaler device was different than the MDPI used in the other treatment arms.'}], 'classes': [{'categories': [{'measurements': [{'value': '52.13', 'spread': '38.071', 'groupId': 'OG000'}, {'value': '203.84', 'spread': '38.072', 'groupId': 'OG001'}, {'value': '248.98', 'spread': '38.025', 'groupId': 'OG002'}, {'value': '279.69', 'spread': '38.121', 'groupId': 'OG003'}, {'value': '303.43', 'spread': '38.062', 'groupId': 'OG004'}, {'value': '245.56', 'spread': '38.148', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.', 'groupDescription': 'A linear in log-dose-trend contrast was constructed to evaluate the dose-response trend, where the logarithm of dose was defined precisely as log (dose+1) to accommodate the case of Fp MDPI 100 mcg, since the dose used in this trend analysis was the salmeterol dose. The study was considered positive if the trend test was positive and the test involving the highest FS MDPI dose (100/50 mcg) compared with Fp MDPI 100 mcg was positive, regardless of the results of the tests for the other doses.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.', 'nonInferiorityComment': 'linearity statistical test'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '251.30', 'ciLowerLimit': '215.6', 'ciUpperLimit': '287.1', 'pValueComment': 'A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.', 'estimateComment': 'FS MDPI 100/50 mcg - Fp MDPI 100 mcg', 'groupDescription': 'The estimated treatment difference from the ANCOVA model between FS MDPI 100/50 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '227.56', 'ciLowerLimit': '191.6', 'ciUpperLimit': '263.5', 'pValueComment': 'A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.', 'estimateComment': 'FS MDPI 100/25 mcg - Fp MDPI 100 mcg', 'groupDescription': 'The estimated treatment difference from the ANCOVA model between FS MDPI 100/25 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '196.85', 'ciLowerLimit': '161.2', 'ciUpperLimit': '232.5', 'pValueComment': 'A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.', 'estimateComment': 'FS MDPI 100/12.5 mcg - Fp MDPI 100 mcg', 'groupDescription': 'The estimated treatment difference from the ANCOVA model between FS MDPI 100/512.5 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '151.71', 'ciLowerLimit': '115.9', 'ciUpperLimit': '187.5', 'pValueComment': 'A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.', 'estimateComment': 'FS MDPI 100/6.25 mcg - Fp MDPI 100 mcg', 'groupDescription': 'The estimated treatment difference from the ANCOVA model between FS MDPI 100/6.25 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG005'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '193.42', 'ciLowerLimit': '157.4', 'ciUpperLimit': '229.5', 'pValueComment': 'A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.', 'estimateComment': 'Advair Diskus 100/50 mcg - Fp MDPI 100', 'groupDescription': 'The estimated treatment difference from the ANCOVA model between Advair Diskus 100/50 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.'}, {'pValue': '0.0017', 'groupIds': ['OG004', 'OG005'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '57.88', 'ciLowerLimit': '22.0', 'ciUpperLimit': '93.7', 'pValueComment': 'A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.', 'estimateComment': 'FS MDPI 100/50 - Advair Diskus 100/50 mcg', 'groupDescription': 'The estimated treatment difference from the ANCOVA model between FS MDPI 100/50 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.'}, {'pValue': '0.0624', 'groupIds': ['OG003', 'OG005'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '34.14', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '70.1', 'pValueComment': 'A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.', 'estimateComment': 'FS MDPI 100/25 mcg - Advair Diskus 100/50 mcg', 'groupDescription': 'The estimated treatment difference from the ANCOVA model between FS MDPI 100/25 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.'}, {'pValue': '0.8503', 'groupIds': ['OG002', 'OG005'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.42', 'ciLowerLimit': '-32.3', 'ciUpperLimit': '39.1', 'pValueComment': 'A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.', 'estimateComment': 'FS MDPI 100/12.5mcg - Advair Diskus 100/50 mcg', 'groupDescription': 'The estimated treatment difference from the ANCOVA model between FS MDPI 100/12.5 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.'}, {'pValue': '0.0229', 'groupIds': ['OG001', 'OG005'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-41.72', 'ciLowerLimit': '-77.6', 'ciUpperLimit': '-5.8', 'pValueComment': 'A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.', 'estimateComment': 'FS MDPI 100/6.25 mcg - Advair Diskus 100/50 mcg', 'groupDescription': 'The estimated treatment difference from the ANCOVA model between FS MDPI 100/6.25 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG005'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-193.42', 'ciLowerLimit': '-229.5', 'ciUpperLimit': '-157.4', 'pValueComment': 'A fixed-sequence testing procedure was employed to control the overall Type I error rate at the 2 sided 0.05 level.', 'estimateComment': 'Fp MDPI 100 mcg - Advair Diskus 100/50 mcg', 'groupDescription': 'The estimated treatment difference from the ANCOVA model between Fp MDPI 100 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Pre-dose: 30 minutes prior, within 5 minutes of dose. Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 9, 12 hours', 'description': 'Standardized baseline-adjusted FEV1 AUC0-12 was defined as the area under the curve for baseline-adjusted FEV1 measurements from the predose to 12 hours postdose time points using the trapezoidal rule based on actual (not scheduled) time of measurement and was standardized by dividing the actual time of last non-missing FEV1 measurement. Baseline-adjusted FEV1 was calculated as postdose FEV1 after subtracting period-specific baseline FEV1. The period-specific baseline FEV1 was measured at predose within 5 minutes of AM dose administration at each treatment visit. If that value was missing, then FEV1 measured at 30 minutes predose was used as the period-specific baseline.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) included all subjects in the ITT population who received at least 1 dose of study drug and had at least 1 evaluable standardized baseline-adjusted FEV1 AUC0-12.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline at 12 Hours Post-Dose in Forced Expiratory Volume in One Second (FEV1) By Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}, {'value': '68', 'groupId': 'OG004'}, {'value': '66', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Fp MDPI 100 mcg', 'description': 'Subjects inhaled a single dose of 100 mcg fluticasone propionate.'}, {'id': 'OG001', 'title': 'FS MDPI 100/6.25 mcg', 'description': 'Subjects inhaled a single dose of 100 mcg fluticasone propionate and 6.25 mcg salmeterol xinafoate.'}, {'id': 'OG002', 'title': 'FS MDPI 100/12.5mcg', 'description': 'Subjects inhaled a single dose of 100 mcg fluticasone propionate and 12.5 mcg salmeterol xinafoate.'}, {'id': 'OG003', 'title': 'FS MDPI 100/25 mcg', 'description': 'Subjects inhaled a single dose of 100 mcg fluticasone propionate and 25 mcg salmeterol xinafoate.'}, {'id': 'OG004', 'title': 'FS MDPI 100/50 mcg', 'description': 'Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate.'}, {'id': 'OG005', 'title': 'Advair Diskus 100/50 mcg', 'description': 'Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate. This arm is the only arm which is open-label because the inhaler device was different than the MDPI used in the other treatment arms.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.53', 'spread': '29.058', 'groupId': 'OG000'}, {'value': '128.49', 'spread': '29.109', 'groupId': 'OG001'}, {'value': '170.51', 'spread': '28.990', 'groupId': 'OG002'}, {'value': '209.85', 'spread': '29.127', 'groupId': 'OG003'}, {'value': '238.30', 'spread': '28.988', 'groupId': 'OG004'}, {'value': '170.54', 'spread': '29.230', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '226.77', 'ciLowerLimit': '172.4', 'ciUpperLimit': '281.1', 'pValueComment': 'significance of 0.05 or alpha of 0.05.', 'estimateComment': 'FS MDPI 100/50 mcg - Fp MDPI 100 mcg', 'groupDescription': 'The estimated treatment difference from the ANCOVA model between each FS MDPI 100/50 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '198.32', 'ciLowerLimit': '143.7', 'ciUpperLimit': '252.9', 'pValueComment': 'significance of 0.05 or alpha of 0.05.', 'estimateComment': 'FS MDPI 100/25 mcg - Fp MDPI 100 mcg', 'groupDescription': 'The estimated treatment difference from the ANCOVA model between each FS MDPI 100/25 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '158.99', 'ciLowerLimit': '104.7', 'ciUpperLimit': '213.3', 'pValueComment': 'significance of 0.05 or alpha of 0.05.', 'estimateComment': 'FS MDPI 100/12.5 mcg - Fp MDPI 100 mcg', 'groupDescription': 'The estimated treatment difference from the ANCOVA model between each FS MDPI 100/12.5 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '116.96', 'ciLowerLimit': '62.4', 'ciUpperLimit': '171.6', 'pValueComment': 'significance of 0.05 or alpha of 0.05.', 'estimateComment': 'FS MDPI 100/6.25 mcg - Fp MDPI 100 mcg', 'groupDescription': 'The estimated treatment difference from the ANCOVA model between each FS MDPI 100/6.25 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG005'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '159.01', 'ciLowerLimit': '104.3', 'ciUpperLimit': '213.7', 'pValueComment': 'significance of 0.05 or alpha of 0.05.', 'estimateComment': 'Advair Diskus 100/50 mcg - Fp MDPI 100 mcg', 'groupDescription': 'The estimated treatment difference from the ANCOVA model between each Advair Diskus 100/50 mcg dose group and Fp MDPI 100 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.'}, {'pValue': '0.0150', 'groupIds': ['OG004', 'OG005'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '67.76', 'ciLowerLimit': '13.3', 'ciUpperLimit': '122.2', 'pValueComment': 'significance of 0.05 or alpha of 0.05.', 'estimateComment': 'FS MDPI 100/50 mcg - Advair Diskus 100/50 mcg', 'groupDescription': 'The estimated treatment difference from the ANCOVA model between each FS MDPI 100/50 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.'}, {'pValue': '0.1578', 'groupIds': ['OG003', 'OG005'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '39.31', 'ciLowerLimit': '-15.3', 'ciUpperLimit': '94.0', 'pValueComment': 'significance of 0.05 or alpha of 0.05.', 'estimateComment': 'FS MDPI 100/25 mcg - Advair Diskus 100/50 mcg', 'groupDescription': 'The estimated treatment difference from the ANCOVA model between each FS MDPI 100/25 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.'}, {'pValue': '0.9993', 'groupIds': ['OG002', 'OG005'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-54.4', 'ciUpperLimit': '54.4', 'pValueComment': 'significance of 0.05 or alpha of 0.05.', 'estimateComment': 'FS MDPI 100/12.5 mcg - Advair Diskus 100/50 mcg', 'groupDescription': 'The estimated treatment difference from the ANCOVA model between each FS MDPI 100/12.5 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.'}, {'pValue': '0.1311', 'groupIds': ['OG001', 'OG005'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-42.05', 'ciLowerLimit': '-96.7', 'ciUpperLimit': '12.6', 'pValueComment': 'significance of 0.05 or alpha of 0.05.', 'estimateComment': 'FS MDPI 100/6.25 mcg - Advair Diskus 100/50 mcg', 'groupDescription': 'The estimated treatment difference from the ANCOVA model between each FS MDPI 100/6.25 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG005'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-159.01', 'ciLowerLimit': '-213.7', 'ciUpperLimit': '-104.3', 'pValueComment': 'significance of 0.05 or alpha of 0.05.', 'estimateComment': 'Fp MDPI 100 mcg - Advair Diskus 100/50 mcg', 'groupDescription': 'The estimated treatment difference from the ANCOVA model between each Fp MDPI 100 mcg dose group and Advair Diskus 100/50 mcg group is presented together with the two-sided 95% CI for the difference and the p-value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Fixed effects of sequence, period and treatment; a random effect of subject within sequence; and a covariate of period-specific baseline FEV1.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Pre-dose: 30 minutes prior, within 5 minutes of dose. Post-dose: 12 hours', 'description': 'The secondary efficacy variable was the change from period-specific baseline in FEV1 at 12 hours, calculated as FEV1 measured at 12 hours postdose after subtracting period-specific baseline FEV1 at each treatment period.\n\nThe period-specific baseline FEV1 was measured at predose within 5 minutes of AM dose administration at each treatment visit. If that value was missing, then FEV1 measured at 30 minutes predose was used as the period-specific baseline.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) included all subjects in the ITT population who received at least 1 dose of study drug and had at least 1 evaluable standardized baseline-adjusted FEV1 AUC0-12.'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC0-t) of Salmeterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}, {'value': '61', 'groupId': 'OG004'}, {'value': '62', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Fp MDPI 100 mcg', 'description': 'Subjects inhaled a single dose of 100 mcg fluticasone propionate.'}, {'id': 'OG001', 'title': 'FS MDPI 100/6.25 mcg', 'description': 'Subjects inhaled a single dose of 100 mcg fluticasone propionate and 6.25 mcg salmeterol xinafoate.'}, {'id': 'OG002', 'title': 'FS MDPI 100/12.5mcg', 'description': 'Subjects inhaled a single dose of 100 mcg fluticasone propionate and 12.5 mcg salmeterol xinafoate.'}, {'id': 'OG003', 'title': 'FS MDPI 100/25 mcg', 'description': 'Subjects inhaled a single dose of 100 mcg fluticasone propionate and 25 mcg salmeterol xinafoate.'}, {'id': 'OG004', 'title': 'FS MDPI 100/50 mcg', 'description': 'Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate.'}, {'id': 'OG005', 'title': 'Advair Diskus 100/50 mcg', 'description': 'Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate. This arm is the only arm which is open-label because the inhaler device was different than the MDPI used in the other treatment arms.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.8', 'spread': '20.98', 'groupId': 'OG001'}, {'value': '69.9', 'spread': '35.36', 'groupId': 'OG002'}, {'value': '133.5', 'spread': '63.13', 'groupId': 'OG003'}, {'value': '309.3', 'spread': '143.43', 'groupId': 'OG004'}, {'value': '173.5', 'spread': '106.59', 'groupId': 'OG005'}]}]}], 'analyses': [{'groupIds': ['OG004', 'OG005'], 'paramType': 'geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.929', 'ciLowerLimit': '1.690', 'ciUpperLimit': '2.202', 'groupDescription': 'The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=58', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG003', 'OG005'], 'paramType': 'geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.800', 'ciLowerLimit': '0.702', 'ciUpperLimit': '0.911', 'groupDescription': 'The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=59', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG005'], 'paramType': 'geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.427', 'ciLowerLimit': '0.376', 'ciUpperLimit': '0.485', 'groupDescription': 'The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=61', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG005'], 'paramType': 'LSM difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.172', 'ciLowerLimit': '0.151', 'ciUpperLimit': '0.196', 'groupDescription': 'The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=59', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Predose (0), and at 5, 10, 15 and 30 minutes, 1, 1.5, 2, 3, 4, 8, and 12 hours postdose', 'description': 'Blood samples for measurement of plasma SAL concentrations were obtained during each treatment visit (subjects 18 years of age and older only) and pharmacokinetic parameters were derived. The primary pharmacokinetic parameters were AUC0-t and Cmax for Salmeterol.', 'unitOfMeasure': 'pg*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis set. PK parameters for Salmeterol were not run for Fp MDPI experience.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) of Salmeterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}, {'value': '61', 'groupId': 'OG004'}, {'value': '62', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Fp MDPI 100 mcg', 'description': 'Subjects inhaled a single dose of 100 mcg fluticasone propionate.'}, {'id': 'OG001', 'title': 'FS MDPI 100/6.25 mcg', 'description': 'Subjects inhaled a single dose of 100 mcg fluticasone propionate and 6.25 mcg salmeterol xinafoate.'}, {'id': 'OG002', 'title': 'FS MDPI 100/12.5mcg', 'description': 'Subjects inhaled a single dose of 100 mcg fluticasone propionate and 12.5 mcg salmeterol xinafoate.'}, {'id': 'OG003', 'title': 'FS MDPI 100/25 mcg', 'description': 'Subjects inhaled a single dose of 100 mcg fluticasone propionate and 25 mcg salmeterol xinafoate.'}, {'id': 'OG004', 'title': 'FS MDPI 100/50 mcg', 'description': 'Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate.'}, {'id': 'OG005', 'title': 'Advair Diskus 100/50 mcg', 'description': 'Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate. This arm is the only arm which is open-label because the inhaler device was different than the MDPI used in the other treatment arms.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.0', 'spread': '8.86', 'groupId': 'OG001'}, {'value': '35.8', 'spread': '20.25', 'groupId': 'OG002'}, {'value': '67.5', 'spread': '34.71', 'groupId': 'OG003'}, {'value': '154.5', 'spread': '80.28', 'groupId': 'OG004'}, {'value': '42.3', 'spread': '19.28', 'groupId': 'OG005'}]}]}], 'analyses': [{'groupIds': ['OG004', 'OG005'], 'paramType': 'geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '3.622', 'ciLowerLimit': '3.149', 'ciUpperLimit': '4.168', 'groupDescription': 'The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=58', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG003', 'OG005'], 'paramType': 'geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.534', 'ciLowerLimit': '1.335', 'ciUpperLimit': '1.763', 'groupDescription': 'The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=59', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG005'], 'paramType': 'geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.795', 'ciLowerLimit': '0.694', 'ciUpperLimit': '0.911', 'groupDescription': 'The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=61', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG001', 'OG005'], 'paramType': 'geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.339', 'ciLowerLimit': '0.295', 'ciUpperLimit': '0.390', 'groupDescription': 'The analysis is based on ANOVA model of the log transformed data, with fixed effects of sequence, period and treatment, and a random effect for subject within sequence. n=59', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Predose (0), and at 5, 10, 15 and 30 minutes, 1, 1.5, 2, 3, 4, 8, and 12 hours postdose', 'description': 'Blood samples for measurement of plasma SAL concentrations were obtained during each treatment visit (subjects 18 years of age and older only) and pharmacokinetic parameters were derived. The primary pharmacokinetic parameters were AUC0-t and Cmax for Salmeterol.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis set. PK parameters for Salmeterol were not run for Fp MDPI experience.'}, {'type': 'SECONDARY', 'title': 'Time of Maximum Observed Plasma Concentration (Tmax) of Salmeterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}, {'value': '61', 'groupId': 'OG004'}, {'value': '62', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Fp MDPI 100 mcg', 'description': 'Subjects inhaled a single dose of 100 mcg fluticasone propionate.'}, {'id': 'OG001', 'title': 'FS MDPI 100/6.25 mcg', 'description': 'Subjects inhaled a single dose of 100 mcg fluticasone propionate and 6.25 mcg salmeterol xinafoate.'}, {'id': 'OG002', 'title': 'FS MDPI 100/12.5mcg', 'description': 'Subjects inhaled a single dose of 100 mcg fluticasone propionate and 12.5 mcg salmeterol xinafoate.'}, {'id': 'OG003', 'title': 'FS MDPI 100/25 mcg', 'description': 'Subjects inhaled a single dose of 100 mcg fluticasone propionate and 25 mcg salmeterol xinafoate.'}, {'id': 'OG004', 'title': 'FS MDPI 100/50 mcg', 'description': 'Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate.'}, {'id': 'OG005', 'title': 'Advair Diskus 100/50 mcg', 'description': 'Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate. This arm is the only arm which is open-label because the inhaler device was different than the MDPI used in the other treatment arms.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '12.1'}, {'value': '0.1', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '2.0'}, {'value': '0.1', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '2.0'}, {'value': '0.1', 'groupId': 'OG004', 'lowerLimit': '0.1', 'upperLimit': '1.5'}, {'value': '0.5', 'groupId': 'OG005', 'lowerLimit': '0.1', 'upperLimit': '2.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Predose (0), and at 5, 10, 15 and 30 minutes, 1, 1.5, 2, 3, 4, 8, and 12 hours postdose', 'description': 'Blood samples for measurement of plasma SAL concentrations were obtained during each treatment visit (subjects 18 years of age and older only) and pharmacokinetic parameters were derived.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis set. PK parameters for Salmeterol were not run for Fp MDPI experience.'}, {'type': 'SECONDARY', 'title': 'Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}, {'value': '68', 'groupId': 'OG004'}, {'value': '66', 'groupId': 'OG005'}, {'value': '72', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Fp MDPI 100 mcg', 'description': 'Subjects inhaled a single dose of 100 mcg fluticasone propionate.'}, {'id': 'OG001', 'title': 'FS MDPI 100/6.25 mcg', 'description': 'Subjects inhaled a single dose of 100 mcg fluticasone propionate and 6.25 mcg salmeterol xinafoate.'}, {'id': 'OG002', 'title': 'FS MDPI 100/12.5mcg', 'description': 'Subjects inhaled a single dose of 100 mcg fluticasone propionate and 12.5 mcg salmeterol xinafoate.'}, {'id': 'OG003', 'title': 'FS MDPI 100/25 mcg', 'description': 'Subjects inhaled a single dose of 100 mcg fluticasone propionate and 25 mcg salmeterol xinafoate.'}, {'id': 'OG004', 'title': 'FS MDPI 100/50 mcg', 'description': 'Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate.'}, {'id': 'OG005', 'title': 'Advair Diskus 100/50 mcg', 'description': 'Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate. This arm is the only arm which is open-label because the inhaler device was different than the MDPI used in the other treatment arms.'}, {'id': 'OG006', 'title': 'Fp MDPI 50 mcg X 2 BID', 'description': "Patients used 2 inhalations of Fp MDPI 50 mcg (100 mcg total dose) twice daily during the 'washout' between treatment periods, so adverse events during this treatment were assigned to Fp MDPI 50 mcg."}], 'classes': [{'title': 'Any adverse event', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}]}]}, {'title': 'Severe adverse event', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'Treatment-related adverse event', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Other serious adverse events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Withdrawn from treatment due to AE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 up to Day 35', 'description': 'TEAEs were recorded during each double-blind treatment. In addition, at the end of each treatment, patients continued to use 2 inhalations of Fp MDPI 50 mcg (100 mcg total dose) twice daily, so adverse events during this treatment were assigned to Fp MDPI 50 mcg.\n\nAn adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relationship of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical in', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Participants', 'description': 'All subjects, regardless of the order of treatments to which they were randomized in this cross-over study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}]}, {'type': 'Received Fp MDPI 100 mcg', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}]}, {'type': 'Received FS MDPI 100/6.25 mcg', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}]}, {'type': 'Received FS MDPI 100/12.5mcg', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}]}, {'type': 'Received FS MDPI 100/25 mcg', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}]}, {'type': 'Received FS MDPI 100/50 mcg', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}]}, {'type': 'Received Advair Diskus 100/50 mcg', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'A total of 105 subjects with asthma were screened for this study. Of the 105 subjects screened, 82 subjects at 10 investigational sites in the US met entry criteria and were considered to be eligible to enter the run-in period.', 'preAssignmentDetails': 'Ten subjects failed randomization.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'All subjects, regardless of the order of treatments to which they were randomized in this cross-over study.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.5', 'spread': '13.87', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '79.2', 'spread': '14.17', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '170.0', 'spread': '9.76', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '27.3', 'spread': '3.35', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Intent-to-Treat population'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'dispFirstSubmitDate': '2015-03-19', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-10', 'studyFirstSubmitDate': '2013-01-17', 'dispFirstSubmitQcDate': '2015-03-19', 'resultsFirstSubmitDate': '2017-02-28', 'studyFirstSubmitQcDate': '2013-01-17', 'dispFirstPostDateStruct': {'date': '2015-04-08', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-28', 'studyFirstPostDateStruct': {'date': '2013-01-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Standardized Baseline-Adjusted Area Under the Curve For Forced Expiratory Volume In 1 Second Over 12 Hours Post-dose (FEV1 AUC0-12)', 'timeFrame': 'Pre-dose: 30 minutes prior, within 5 minutes of dose. Post-dose: 0.5, 1, 2, 3, 4, 5, 6, 9, 12 hours', 'description': 'Standardized baseline-adjusted FEV1 AUC0-12 was defined as the area under the curve for baseline-adjusted FEV1 measurements from the predose to 12 hours postdose time points using the trapezoidal rule based on actual (not scheduled) time of measurement and was standardized by dividing the actual time of last non-missing FEV1 measurement. Baseline-adjusted FEV1 was calculated as postdose FEV1 after subtracting period-specific baseline FEV1. The period-specific baseline FEV1 was measured at predose within 5 minutes of AM dose administration at each treatment visit. If that value was missing, then FEV1 measured at 30 minutes predose was used as the period-specific baseline.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline at 12 Hours Post-Dose in Forced Expiratory Volume in One Second (FEV1) By Treatment', 'timeFrame': 'Pre-dose: 30 minutes prior, within 5 minutes of dose. Post-dose: 12 hours', 'description': 'The secondary efficacy variable was the change from period-specific baseline in FEV1 at 12 hours, calculated as FEV1 measured at 12 hours postdose after subtracting period-specific baseline FEV1 at each treatment period.\n\nThe period-specific baseline FEV1 was measured at predose within 5 minutes of AM dose administration at each treatment visit. If that value was missing, then FEV1 measured at 30 minutes predose was used as the period-specific baseline.'}, {'measure': 'Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Measurable Concentration (AUC0-t) of Salmeterol', 'timeFrame': 'Predose (0), and at 5, 10, 15 and 30 minutes, 1, 1.5, 2, 3, 4, 8, and 12 hours postdose', 'description': 'Blood samples for measurement of plasma SAL concentrations were obtained during each treatment visit (subjects 18 years of age and older only) and pharmacokinetic parameters were derived. The primary pharmacokinetic parameters were AUC0-t and Cmax for Salmeterol.'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of Salmeterol', 'timeFrame': 'Predose (0), and at 5, 10, 15 and 30 minutes, 1, 1.5, 2, 3, 4, 8, and 12 hours postdose', 'description': 'Blood samples for measurement of plasma SAL concentrations were obtained during each treatment visit (subjects 18 years of age and older only) and pharmacokinetic parameters were derived. The primary pharmacokinetic parameters were AUC0-t and Cmax for Salmeterol.'}, {'measure': 'Time of Maximum Observed Plasma Concentration (Tmax) of Salmeterol', 'timeFrame': 'Predose (0), and at 5, 10, 15 and 30 minutes, 1, 1.5, 2, 3, 4, 8, and 12 hours postdose', 'description': 'Blood samples for measurement of plasma SAL concentrations were obtained during each treatment visit (subjects 18 years of age and older only) and pharmacokinetic parameters were derived.'}, {'measure': 'Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period', 'timeFrame': 'Day 1 up to Day 35', 'description': 'TEAEs were recorded during each double-blind treatment. In addition, at the end of each treatment, patients continued to use 2 inhalations of Fp MDPI 50 mcg (100 mcg total dose) twice daily, so adverse events during this treatment were assigned to Fp MDPI 50 mcg.\n\nAn adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relationship of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical in'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Asthma', 'dry powder inhaler', 'long-acting beta2-agonist', 'bronchodilation', 'bronchodilator', 'metered dose inhaler', 'inhaled corticosteroid'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the dose response, efficacy, and safety of 4 different doses of salmeterol Spiromax (6.25, 12.5, 25, and 50 mcg) each combined with a fixed dose of fluticasone propionate (100 mcg) delivered as Fluticasone/Salmeterol Spiromax® Inhalation Powder (FS Spiromax) when administered as a single dose in subjects 12 years of age and older with persistent asthma.', 'detailedDescription': "This was a multicenter, randomized, double-blind and open-label active-controlled, single-dose, 6 period crossover, dose-ranging study conducted in male and female subjects ages 12 years and older with persistent asthma.\n\nFluticasone propionate multidose dry powder inhaler (Fp MDPI) 50 mcg was provided (to replace the subject's current inhaled corticosteroid (ICS)) throughout the 14 day run-in period and each of the washout periods between treatments. Subjects were instructed to administer 2 inhalations of Fp MDPI 50 mcg (100 mcg total dose) twice daily during the run-in and washout periods. All other medications for the treatment of asthma were discontinued at or prior to the screening visit.\n\nA short-acting β2-adrenergic agonist (SABA), salbuterol HFA, MDI, was provided (to replace the subject's current rescue medication) for symptomatic relief of asthma symptoms in each the run-in, treatment, and washout periods.\n\nTreatment period lasted 5 weeks with a 5 to 7 day washout between each of the six single dose treatments:\n\n* fluticasone propionate/salmeterol xinafoate multidose dry powder inhaler (FS MDPI) given in doses of 6.25, 12.5, 25, or 50 mcg of salmeterol xinafoate in blinded fashion.\n* fluticasone propionate multidose dry powder inhaler (Fp MDPI) 100 mcg in blinded fashion\n* ADVAIR DISKUS, 100/50 mcg in open-label fashion"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent/assent\n* General good health\n* Diagnosis of asthma as defined by the National Institutes of Health (NIH)\n* A best FEV1 of 40%-85% of the predicted normal value during the screening visit (SV)\n* Subjects need to demonstrate a ≥ 15% reversibility of FEV1 within 30 minutes following 4 inhalations of albuterol inhalation aerosol (if required, spacers are permitted for reversibility testing) at the SV.\n* Other inclusion criteria apply\n\nExclusion Criteria:\n\n* History of life-threatening asthma that is defined for this protocol as an asthma episode that required intubation.\n* Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that is not resolved within 2 weeks prior to the SV.\n* Any asthma exacerbation requiring oral corticosteroids within 3 months of the SV. A subject must not have had any hospitalization for asthma within 6 months prior to the SV.\n* Taking long-acting β-agonists within 2 weeks of the SV\n* Other exclusion criteria apply.'}, 'identificationModule': {'nctId': 'NCT01772368', 'briefTitle': 'Dose Ranging Study of the Salmeterol Component of Fluticasone /Salmeterol Spiromax Compared to Fluticasone Spiromax and Advair Diskus in Asthma Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': 'A Six-Period Crossover, Dose-Ranging Study to Evaluate the Efficacy and Safety of Four Doses of FS Spiromax (Fluticasone Propionate/Salmeterol Xinafoate Inhalation Powder) Administered as Single Doses Compared With Single Doses of Fluticasone Propionate Spiromax and Open Label Advair Diskus in Adult and Adolescent Subjects With Persistent Asthma', 'orgStudyIdInfo': {'id': 'FSS-AS-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FS MDPI 100/6.25 mcg', 'description': 'Subjects inhaled a single dose of 100 mcg fluticasone propionate and 6.25 mcg salmeterol xinafoate.', 'interventionNames': ['Drug: FS MDPI', 'Drug: Albuterol']}, {'type': 'EXPERIMENTAL', 'label': 'FS MDPI 100/12.5mcg', 'description': 'Subjects inhaled a single dose of 100 mcg fluticasone propionate and 12.5 mcg salmeterol xinafoate.', 'interventionNames': ['Drug: FS MDPI', 'Drug: Albuterol']}, {'type': 'EXPERIMENTAL', 'label': 'FS MDPI 100/25', 'description': 'Subjects inhaled a single dose of 100 mcg fluticasone propionate and 25 mcg salmeterol xinafoate.', 'interventionNames': ['Drug: FS MDPI', 'Drug: Albuterol']}, {'type': 'EXPERIMENTAL', 'label': 'FS MDPI 100/50', 'description': 'Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate.', 'interventionNames': ['Drug: FS MDPI', 'Drug: Albuterol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fp MDPI 100 mcg', 'description': 'Subjects inhaled a single dose of 100 mcg fluticasone propionate.', 'interventionNames': ['Drug: Fp MDPI', 'Drug: Albuterol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Advair Diskus 100/50 mcg', 'description': 'Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate. This arm is the only arm which is open-label because the inhaler device was different than the MDPI used in the other treatment arms.', 'interventionNames': ['Drug: Advair Diskus', 'Drug: Albuterol']}], 'interventions': [{'name': 'Fp MDPI', 'type': 'DRUG', 'otherNames': ['fluticasone propionate', 'inhaled corticosteroid', 'Fp Spiromax'], 'description': "Fp MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate dispersed in a lactose monohydrate excipient and contained within a reservoir. A metered dose of drug is delivered to a dose cup via an air pulse activated when the cap is opened.\n\nFp at 100 mcg was an active comparator (single dose). Further, participants were instructed to administer two inhalations of Fp MDPI 50 mcg twice daily (100 mcg total dose) during the Run-in (to replace the participant's current inhaled corticosteroid) and Washout Periods between treatments.", 'armGroupLabels': ['Fp MDPI 100 mcg']}, {'name': 'FS MDPI', 'type': 'DRUG', 'otherNames': ['fluticasone propionate', 'inhaled corticosteroid', 'Salmeterol xinafoate', 'β2 adrenoceptor agonist', 'FS Spiromax'], 'description': 'FS MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate and salmeterol xinafoate dispersed in a lactose monohydrate excipient and contained within a reservoir. A metered dose of drug is delivered to a dose cup via an air pulse activated when the cap is opened. The fluticasone propionate component was a fixed dose of 100 mcg. The salmeterol xinofoate dosage varied: 6.25, 12.5, 25 or 50 mcg.', 'armGroupLabels': ['FS MDPI 100/12.5mcg', 'FS MDPI 100/25', 'FS MDPI 100/50', 'FS MDPI 100/6.25 mcg']}, {'name': 'Advair Diskus', 'type': 'DRUG', 'otherNames': ['fluticasone propionate', 'inhaled corticosteroid', 'salmeterol xinafoate', 'β2 adrenoceptor agonist'], 'description': 'ADVAIR DISKUS (100/50 mcg fluticasone propionate/salmeterol xinafoate) consists of a dry powder formulation of fluticasone propionate and salmeterol xinafoate in a lactose excipient. The dry powder is contained within individual blisters on a double foil strip within the device. Activation of the device opens a single blister of medication which is then dispersed into the air-stream by patient inhalation.', 'armGroupLabels': ['Advair Diskus 100/50 mcg']}, {'name': 'Albuterol', 'type': 'DRUG', 'otherNames': ['Pro-Air', 'short-acting β2-adrenergic agonists'], 'description': "Albuterol (Pro-Air) hydrofluoroalkane (HFA) metered dose inhaler (MDI), was provided to be used as needed for the relief of asthma symptoms during both the run-in and treatment periods (to replace the subject's current rescue medication).", 'armGroupLabels': ['Advair Diskus 100/50 mcg', 'FS MDPI 100/12.5mcg', 'FS MDPI 100/25', 'FS MDPI 100/50', 'FS MDPI 100/6.25 mcg', 'Fp MDPI 100 mcg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Teva Investigational Site 10453', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'North Dartmouth', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Teva Investigational Site 10452', 'geoPoint': {'lat': 41.63899, 'lon': -70.97032}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Teva Investigational Site 10455', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'Skillman', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Teva Investigational Site 10454', 'geoPoint': {'lat': 40.42011, 'lon': -74.7146}}, {'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Teva Investigational Site 10448', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'city': 'Medford', 'state': 'Oregon', 'country': 'United States', 'facility': 'Teva Investigational Site 10451', 'geoPoint': {'lat': 42.32652, 'lon': -122.87559}}, {'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Teva Investigational Site 10449', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'Teva Investigational Site 10457', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'city': 'New Braunfels', 'state': 'Texas', 'country': 'United States', 'facility': 'Teva Investigational Site 10450', 'geoPoint': {'lat': 29.703, 'lon': -98.12445}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Teva Investigational Site 10456', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teva Branded Pharmaceutical Products R&D, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}