Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-25 @ 7:54 PM
Study NCT ID:
NCT00712335
Status:
COMPLETED
Last Update Posted:
2012-05-16
First Post:
2008-07-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The Effects of Montelukast on Smokers With Asthma
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': 'C093875', 'term': 'montelukast'}, {'id': 'D020024', 'term': 'Leukotriene Antagonists'}, {'id': 'D000068299', 'term': 'Salmeterol Xinafoate'}], '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': 'D006727', 'term': 'Hormone Antagonists'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000420', 'term': 'Albuterol'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kimck@paik.ac.kr', 'phone': '82-2-950-8832', 'title': 'Dr. Chang-Keun Kim', 'organization': 'Inje University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'It is difficult attaining representative gender ratios (i.e., representative of the general population) when conducting a smoking study in Korea, as smoking by females is still considered culturally taboo.'}}, 'adverseEventsModule': {'description': 'Normal Controls were not assessed for Adverse Events because they were not administered any treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Asthmatic Smokers Treated With Combination Therapy', 'description': 'Asthmatic smokers treated with combination therapy:\n\nFluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months', 'otherNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Asthmatic Smoker Treated With Montelukast Only', 'description': 'Asthmatic smoker treated with Montelukast only:\n\nMontelukast dosage - PO 10 mg QHS for 3 months', 'otherNumAtRisk': 32, 'otherNumAffected': 0, 'seriousNumAtRisk': 32, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Non-smoking Asthmatic Treated With Combination Therapy', 'description': 'Non-smoking asthmatic treated with combination therapy:\n\nFluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months', 'otherNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Non-smoking Asthmatic Treated With Montelukast Only', 'description': 'Non-smoking asthmatic treated with Montelukast only:\n\nMontelukast dosage - PO 10 mg QHS for 3 months', 'otherNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Normal Controls', 'description': 'Normal controls did not receive any treatment.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Sputum Eosinophil Percentages', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Asthmatic Smokers Treated With Combination Therapy', 'description': 'Asthmatic smokers treated with combination therapy:\n\nFluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months'}, {'id': 'OG001', 'title': 'Asthmatic Smoker Treated With Montelukast Only', 'description': 'Asthmatic smoker treated with Montelukast only:\n\nMontelukast dosage - PO 10 mg QHS for 3 months'}, {'id': 'OG002', 'title': 'Non-smoking Asthmatic Treated With Combination Therapy', 'description': 'Non-smoking asthmatic treated with combination therapy:\n\nFluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months'}, {'id': 'OG003', 'title': 'Non-smoking Asthmatic Treated With Montelukast Only', 'description': 'Non-smoking asthmatic treated with Montelukast only:\n\nMontelukast dosage - PO 10 mg QHS for 3 months'}, {'id': 'OG004', 'title': 'Normal Controls', 'description': 'Normal controls did not receive any treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.33', 'spread': '3.01', 'groupId': 'OG000'}, {'value': '3.60', 'spread': '6.43', 'groupId': 'OG001'}, {'value': '1.60', 'spread': '1.34', 'groupId': 'OG002'}, {'value': '3.26', 'spread': '6.10', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'Secondary endpoints of inflammatory markers (sputum eosinophil percentages at 24 weeks) were measured in active treatment groups', 'unitOfMeasure': 'percentage of eosinophils', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We will use ITT and PP protocols for analysis'}, {'type': 'PRIMARY', 'title': 'Sputum Neutrophil Percentages', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Asthmatic Smokers Treated With Combination Therapy', 'description': 'Asthmatic smokers treated with combination therapy:\n\nFluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months'}, {'id': 'OG001', 'title': 'Asthmatic Smoker Treated With Montelukast Only', 'description': 'Asthmatic smoker treated with Montelukast only:\n\nMontelukast dosage - PO 10 mg QHS for 3 months'}, {'id': 'OG002', 'title': 'Non-smoking Asthmatic Treated With Combination Therapy', 'description': 'Non-smoking asthmatic treated with combination therapy:\n\nFluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months'}, {'id': 'OG003', 'title': 'Non-smoking Asthmatic Treated With Montelukast Only', 'description': 'Non-smoking asthmatic treated with Montelukast only:\n\nMontelukast dosage - PO 10 mg QHS for 3 months'}, {'id': 'OG004', 'title': 'Normal Controls', 'description': 'Normal controls did not receive any treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '86.00', 'spread': '8.22', 'groupId': 'OG000'}, {'value': '72.53', 'spread': '24.14', 'groupId': 'OG001'}, {'value': '89.33', 'spread': '6.41', 'groupId': 'OG002'}, {'value': '79.84', 'spread': '17.07', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'Week 24 sputum neutrophil percentages were measured in active treatment groups.', 'unitOfMeasure': 'percentage of neutrophils', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We will be using intention-to-treat and per protocol for analysis.'}, {'type': 'SECONDARY', 'title': 'Sputum IL-8 Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Asthmatic Smokers Treated With Combination Therapy', 'description': 'Asthmatic smokers treated with combination therapy:\n\nFluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months'}, {'id': 'OG001', 'title': 'Asthmatic Smoker Treated With Montelukast Only', 'description': 'Asthmatic smoker treated with Montelukast only:\n\nMontelukast dosage - PO 10 mg QHS for 3 months'}, {'id': 'OG002', 'title': 'Non-smoking Asthmatic Treated With Combination Therapy', 'description': 'Non-smoking asthmatic treated with combination therapy:\n\nFluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months'}, {'id': 'OG003', 'title': 'Non-smoking Asthmatic Treated With Montelukast Only', 'description': 'Non-smoking asthmatic treated with Montelukast only:\n\nMontelukast dosage - PO 10 mg QHS for 3 months'}, {'id': 'OG004', 'title': 'Normal Controls', 'description': 'Normal controls did not receive any treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '334545', 'spread': '804,831', 'groupId': 'OG000'}, {'value': '26,300', 'spread': '74,106', 'groupId': 'OG001'}, {'value': '3602', 'spread': '2342', 'groupId': 'OG002'}, {'value': '317778', 'spread': '738415', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'Week 24 sputum IL-8 levels in active treatment groups', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We will ITT and PP protocols for analysis'}, {'type': 'SECONDARY', 'title': 'Sputum GM-CSF Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Asthmatic Smokers Treated With Combination Therapy', 'description': 'Asthmatic smokers treated with combination therapy:\n\nFluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months'}, {'id': 'OG001', 'title': 'Asthmatic Smoker Treated With Montelukast Only', 'description': 'Asthmatic smoker treated with Montelukast only:\n\nMontelukast dosage - PO 10 mg QHS for 3 months'}, {'id': 'OG002', 'title': 'Non-smoking Asthmatic Treated With Combination Therapy', 'description': 'Non-smoking asthmatic treated with combination therapy:\n\nFluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months'}, {'id': 'OG003', 'title': 'Non-smoking Asthmatic Treated With Montelukast Only', 'description': 'Non-smoking asthmatic treated with Montelukast only:\n\nMontelukast dosage - PO 10 mg QHS for 3 months'}, {'id': 'OG004', 'title': 'Normal Controls', 'description': 'Normal controls did not receive any treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.60', 'spread': '24.67', 'groupId': 'OG000'}, {'value': '15.18', 'spread': '16.37', 'groupId': 'OG001'}, {'value': '13.92', 'spread': '10.66', 'groupId': 'OG002'}, {'value': '12.16', 'spread': '18.05', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'Week 24 sputum GM-CSF levels in active treatment groups were measured.', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We will use ITT and PP for analysis'}, {'type': 'SECONDARY', 'title': 'Sputum IFN-gamma/IL-5 Ratios', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Asthmatic Smokers Treated With Combination Therapy', 'description': 'Asthmatic smokers treated with combination therapy:\n\nFluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months'}, {'id': 'OG001', 'title': 'Asthmatic Smoker Treated With Montelukast Only', 'description': 'Asthmatic smoker treated with Montelukast only:\n\nMontelukast dosage - PO 10 mg QHS for 3 months'}, {'id': 'OG002', 'title': 'Non-smoking Asthmatic Treated With Combination Therapy', 'description': 'Non-smoking asthmatic treated with combination therapy:\n\nFluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months'}, {'id': 'OG003', 'title': 'Non-smoking Asthmatic Treated With Montelukast Only', 'description': 'Non-smoking asthmatic treated with Montelukast only:\n\nMontelukast dosage - PO 10 mg QHS for 3 months'}, {'id': 'OG004', 'title': 'Normal Controls', 'description': 'Normal controls did not receive any treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '627.4', 'spread': '742.1', 'groupId': 'OG000'}, {'value': '272.4', 'spread': '387.1', 'groupId': 'OG001'}, {'value': '183.8', 'spread': '82.70', 'groupId': 'OG002'}, {'value': '279.0', 'spread': '563.3', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'Week 24 sputum IFN-gamma/IL-5 ratios were determined in active treatment groups.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT and PP were used for analysis.'}, {'type': 'SECONDARY', 'title': 'Sputum Eotaxin Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Asthmatic Smokers Treated With Combination Therapy', 'description': 'Asthmatic smokers treated with combination therapy:\n\nFluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months'}, {'id': 'OG001', 'title': 'Asthmatic Smoker Treated With Montelukast Only', 'description': 'Asthmatic smoker treated with Montelukast only:\n\nMontelukast dosage - PO 10 mg QHS for 3 months'}, {'id': 'OG002', 'title': 'Non-smoking Asthmatic Treated With Combination Therapy', 'description': 'Non-smoking asthmatic treated with combination therapy:\n\nFluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months'}, {'id': 'OG003', 'title': 'Non-smoking Asthmatic Treated With Montelukast Only', 'description': 'Non-smoking asthmatic treated with Montelukast only:\n\nMontelukast dosage - PO 10 mg QHS for 3 months'}, {'id': 'OG004', 'title': 'Normal Controls', 'description': 'Normal controls did not receive any treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '47.13', 'spread': '41.93', 'groupId': 'OG000'}, {'value': '87.90', 'spread': '93.15', 'groupId': 'OG001'}, {'value': '65.14', 'spread': '25.54', 'groupId': 'OG002'}, {'value': '64.61', 'spread': '44.07', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'Week 24 sputum eotaxin levels in active treatment groups were measured.', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT and PP were used for analysis.'}, {'type': 'SECONDARY', 'title': 'Sputum RANTES Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Asthmatic Smokers Treated With Combination Therapy', 'description': 'Asthmatic smokers treated with combination therapy:\n\nFluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months'}, {'id': 'OG001', 'title': 'Asthmatic Smoker Treated With Montelukast Only', 'description': 'Asthmatic smoker treated with Montelukast only:\n\nMontelukast dosage - PO 10 mg QHS for 3 months'}, {'id': 'OG002', 'title': 'Non-smoking Asthmatic Treated With Combination Therapy', 'description': 'Non-smoking asthmatic treated with combination therapy:\n\nFluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months'}, {'id': 'OG003', 'title': 'Non-smoking Asthmatic Treated With Montelukast Only', 'description': 'Non-smoking asthmatic treated with Montelukast only:\n\nMontelukast dosage - PO 10 mg QHS for 3 months'}, {'id': 'OG004', 'title': 'Normal Controls', 'description': 'Normal controls did not receive any treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '42.79', 'spread': '32.47', 'groupId': 'OG000'}, {'value': '44.03', 'spread': '40.41', 'groupId': 'OG001'}, {'value': '41.78', 'spread': '19.93', 'groupId': 'OG002'}, {'value': '36.41', 'spread': '29.93', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'Week 24 sputum RANTES levels in active treatment groups were measured.', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT and PP were used for analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Asthmatic Smokers Treated With Combination Therapy', 'description': 'Asthmatic smokers treated with combination therapy:\n\nFluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months'}, {'id': 'FG001', 'title': 'Asthmatic Smoker Treated With Montelukast Only', 'description': 'Asthmatic smoker treated with Montelukast only:\n\nMontelukast dosage - PO 10 mg QHS for 3 months'}, {'id': 'FG002', 'title': 'Non-smoking Asthmatic Treated With Combination Therapy', 'description': 'Non-smoking asthmatic treated with combination therapy:\n\nFluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months'}, {'id': 'FG003', 'title': 'Non-smoking Asthmatic Treated With Montelukast Only', 'description': 'Non-smoking asthmatic treated with Montelukast only:\n\nMontelukast dosage - PO 10 mg QHS for 3 months'}, {'id': 'FG004', 'title': 'Normal Controls', 'description': 'Normal controls did not receive any treatment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '24'}, {'groupId': 'FG004', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '19'}, {'groupId': 'FG004', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Other Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment period: January 2008-April 2011 Recruitment location: Asthma and Allergy Center, Inje University Sanggye Paik Hospital', 'preAssignmentDetails': 'After randomization, a 10-day washout period followed in which subjects were taken off all medications except albuterol metered dose inhaler as needed. After the washout period, baseline induced sputum was obtained in each group along with primary and secondary endpoints. This was followed by a 3-week run in period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}, {'value': '105', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Asthmatic Smokers Treated With Combination Therapy', 'description': 'Asthmatic smokers treated with combination therapy:\n\nFluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months'}, {'id': 'BG001', 'title': 'Asthmatic Smoker Treated With Montelukast Only', 'description': 'Asthmatic smoker treated with Montelukast only:\n\nMontelukast dosage - PO 10 mg QHS for 3 months'}, {'id': 'BG002', 'title': 'Non-smoking Asthmatic Treated With Combination Therapy', 'description': 'Non-smoking asthmatic treated with combination therapy:\n\nFluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months'}, {'id': 'BG003', 'title': 'Non-smoking Asthmatic Treated With Montelukast Only', 'description': 'Non-smoking asthmatic treated with Montelukast only:\n\nMontelukast dosage - PO 10 mg QHS for 3 months'}, {'id': 'BG004', 'title': 'Normal Controls', 'description': 'Normal controls did not receive any treatment.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}, {'value': '105', 'groupId': 'BG005'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.38', 'spread': '11.41', 'groupId': 'BG000'}, {'value': '36.03', 'spread': '8.52', 'groupId': 'BG001'}, {'value': '45.64', 'spread': '17.46', 'groupId': 'BG002'}, {'value': '39.00', 'spread': '14.79', 'groupId': 'BG003'}, {'value': '40.55', 'spread': '11.35', 'groupId': 'BG004'}, {'value': '40.09', 'spread': '4.24', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}, {'value': '56', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '49', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Korea, Republic of', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}, {'value': '105', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-18', 'studyFirstSubmitDate': '2008-07-07', 'resultsFirstSubmitDate': '2011-11-16', 'studyFirstSubmitQcDate': '2008-07-07', 'lastUpdatePostDateStruct': {'date': '2012-05-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-04-18', 'studyFirstPostDateStruct': {'date': '2008-07-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sputum Neutrophil Percentages', 'timeFrame': '24 weeks', 'description': 'Week 24 sputum neutrophil percentages were measured in active treatment groups.'}], 'secondaryOutcomes': [{'measure': 'Sputum Eosinophil Percentages', 'timeFrame': '24 weeks', 'description': 'Secondary endpoints of inflammatory markers (sputum eosinophil percentages at 24 weeks) were measured in active treatment groups'}, {'measure': 'Sputum IL-8 Levels', 'timeFrame': '24 weeks', 'description': 'Week 24 sputum IL-8 levels in active treatment groups'}, {'measure': 'Sputum GM-CSF Levels', 'timeFrame': '24 weeks', 'description': 'Week 24 sputum GM-CSF levels in active treatment groups were measured.'}, {'measure': 'Sputum IFN-gamma/IL-5 Ratios', 'timeFrame': '24 weeks', 'description': 'Week 24 sputum IFN-gamma/IL-5 ratios were determined in active treatment groups.'}, {'measure': 'Sputum Eotaxin Levels', 'timeFrame': '24 weeks', 'description': 'Week 24 sputum eotaxin levels in active treatment groups were measured.'}, {'measure': 'Sputum RANTES Levels', 'timeFrame': '24 weeks', 'description': 'Week 24 sputum RANTES levels in active treatment groups were measured.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['asthmatics', 'smokers', 'inhaled corticosteroids', 'leukotriene receptor antagonists'], 'conditions': ['Asthmatic Smokers', 'Non-asthmatic Smokers']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is:\n\n1. To compare neutrophilia, eosinophilic inflammatory markers and asthma symptom indices between smokers and non-smokers.\n2. To elucidate the mechanism by which cigarette smokers are resistant to corticosteroids.', 'detailedDescription': "Many smokers have insufficient control of their symptoms due to inefficacy of ICS in this subpopulation of asthmatics. Cigarette smoking has been shown to stimulate production of cysLTs. CysLTs could activate production of IL-8 for neutrophilia as well as cause eosinophilia in the airway of asthmatics.\n\nLTRAs are felt to be less efficacious than ICS in smokers with asthma. However, LTRA's unique mechanism of action could be particularly efficacious in preventing worsening symptoms and lung function for smokers with asthma. Given this, along with the fact that ICS are less effective in smokers, targeting cysLT could lead to significant clinical benefits for asthmatic smokers.\n\nData from this study may possibly serve as crucial data for the significant clinical benefits for asthmatic smokers and determination of the mechanism of corticosteroid resistance in smokers with asthma."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAsthmatics:\n\n* clinical history of asthma for at least 1 year\n* with evidence of reversible airway obstruction,\n* two documented FEV1 between 60-85%,\n* PC20 \\< 4mg/ml by methacholine challenge test\n* and average baseline β-agonist use of 2 puffs/day\n\nSmokers:\n\n* smoke 1/2 to 2 packs a day\n* with a smoking history of 5-30 pack years\n\nNon-smokers:\n\n* Non-smokers will have either never smoked or have stopped smoking cigarettes over 5 years ago\n\nExclusion Criteria:\n\n* positive HCG (for females)\n* have a respiratory tract infection or need oral corticosteroids within the preceding 6 weeks\n* history of COPD or respiratory disorder other than asthma\n* history of psychiatric illness\n* allergy to fluticasone propionate, salmeterol, montelukast or any of their components\n* significant, unstable medical condition other than asthma\n* history of life-threatening asthma exacerbation requiring intubation and mechanical ventilation in the last ten years'}, 'identificationModule': {'nctId': 'NCT00712335', 'briefTitle': 'The Effects of Montelukast on Smokers With Asthma', 'organization': {'class': 'OTHER', 'fullName': 'Inje University'}, 'officialTitle': 'The Effects of Montelukast on Sputum Cells and Inflammatory Markers in Smokers With Asthma', 'orgStudyIdInfo': {'id': 'MASK2008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Asthmatic smokers treated with combination therapy:\n\nFluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months', 'interventionNames': ['Drug: Fluticasone Propionate', 'Drug: Salmeterol']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Asthmatic smoker treated with Montelukast only:\n\nMontelukast dosage: PO 10 mg QHS for 3 months', 'interventionNames': ['Drug: Montelukast']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'Non-smoking asthmatics treated with combination therapy:\n\nFluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months', 'interventionNames': ['Drug: Fluticasone Propionate', 'Drug: Salmeterol']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4', 'description': 'Non-smoking asthmatic treated with Montelukast only:\n\nMontelukast dosage: PO 10 mg QHS for 3 months', 'interventionNames': ['Drug: Montelukast']}, {'type': 'NO_INTERVENTION', 'label': '5', 'description': 'Normal controls'}], 'interventions': [{'name': 'Fluticasone Propionate', 'type': 'DRUG', 'otherNames': ['inhaled corticosteroid'], 'description': 'DPI 250 mcg BID for 3 weeks', 'armGroupLabels': ['1', '3']}, {'name': 'Montelukast', 'type': 'DRUG', 'otherNames': ['leukotriene receptor antagonist'], 'description': 'PO 10 mg QHS for 3 weeks', 'armGroupLabels': ['2', '4']}, {'name': 'Salmeterol', 'type': 'DRUG', 'otherNames': ['long-acting beta-agonist'], 'description': 'DPI 50mg BID for 3 weeks', 'armGroupLabels': ['1', '3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '139-707', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asthma and Allergy Center, Inje University Sanggye Paik Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Chang-Keun Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asthma and Allergy Center, Inje University Sanggye Paik Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inje University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Asthma and Allergy Center; Chairman of Pediatrics; Professor of Pediatrics', 'investigatorFullName': 'Chang-Keun Kim, Dr.', 'investigatorAffiliation': 'Inje University'}}}}