Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-28 @ 12:02 AM
Study NCT ID:
NCT00809094
Status:
COMPLETED
Last Update Posted:
2013-04-22
First Post:
2008-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
NAC Phase IIB: A Multi-Center, Phase IIB, Randomized, Placebo-controlled, Double-Blind Study Of The Effects Of N-Acetylcysteine On Redox Changes and Lung Inflammation In Cystic Fibrosis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000111', 'term': 'Acetylcysteine'}], 'ancestors': [{'id': 'D003545', 'term': 'Cysteine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cconrad@stanford.edu', 'phone': '650-723-8325', 'title': 'Dr. Carol Conrad', 'organization': 'Stanford University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Study Drug', 'description': 'N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).', 'otherNumAtRisk': 36, 'otherNumAffected': 33, 'seriousNumAtRisk': 36, 'seriousNumAffected': 15}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)', 'otherNumAtRisk': 34, 'otherNumAffected': 30, 'seriousNumAtRisk': 34, 'seriousNumAffected': 17}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 17, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 21, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Forced Expiratory Volume Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 14, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-cardiac Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 14, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary function test decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'white blood cell count increased', 'notes': 's', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 18, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nephrolitiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 55, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 45, 'numAffected': 21}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 12, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 16, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Paranasal sinus hypersecretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Postnasal drip', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 18, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rales', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory tract congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 9, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rhinorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Pulmonary Exacerbation', 'notes': 'These events were not considered related to study drug by the treating physician', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 34, 'numAffected': 17}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in the Logarithm of the Level of Human Neutrophil Elastase (HNE) Activity Measured in Sputum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Drug', 'description': 'N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000', 'lowerLimit': '-1.12', 'upperLimit': '1.38'}, {'value': '-0.17', 'groupId': 'OG001', 'lowerLimit': '-1.20', 'upperLimit': '0.67'}]}]}], 'analyses': [{'pValue': '0.14', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.21', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.48', 'groupDescription': 'Null hypothesis: there will be no difference in the change in human neutrophil activity measured from baseline to end of the study (24 weeks)', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LOG_MEAN', 'timeFrame': 'From enrollment to end of the 24-week trial', 'description': '(change in log10 HNE in the active treatment group) - (change in log10 HNE in the placebo group)', 'unitOfMeasure': 'log10 mcg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary endpoint analyses described uses the subset of the ITT population with complete case data. 70 subjects randomized, 65 completed the Week 12 visit and 62 completed the study. There were 6 withdrawals in the NAC group and 2 in Placebo. Five out of 6 subjects in the NAC group withdrew due to subject decision. Missing data was not imputed.'}, {'type': 'SECONDARY', 'title': 'Change in FEV1 (Percent of Predicted for Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Drug', 'description': 'N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.055', 'groupId': 'OG000', 'lowerLimit': '-26.16', 'upperLimit': '25.73'}, {'value': '-5.62', 'groupId': 'OG001', 'lowerLimit': '-24.54', 'upperLimit': '19.69'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From enrollment to the end of the 24-week trial', 'description': 'Change in forced expiratory volume in 1 second as compared to normals for age (percent of predicted)', 'unitOfMeasure': 'percent of predicted vlaues', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Out of 70 subjects randomized, 65 completed the Week 12 visit and 62 completed the study. There were 6 withdrawals in the NAC group and 2 in Placebo. Five out of 6 subjects in the NAC group withdrew due to subject decision. Missing data was not imputed.'}, {'type': 'SECONDARY', 'title': 'FEV1 (L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Drug', 'description': 'N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '-21.92', 'upperLimit': '30.28'}, {'value': '-4.35', 'groupId': 'OG001', 'lowerLimit': '-25.00', 'upperLimit': '22.94'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to end of study (24 weeks)', 'description': 'Forced expiratory volume in 1 second (Liters)', 'unitOfMeasure': 'Liter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Out of 70 subjects randomized, 65 completed the Week 12 visit and 62 completed the study. There were 6 withdrawals in the NAC group and 2 in Placebo. Five out of 6 subjects in the NAC group withdrew due to subject decision. Missing data was not imputed.'}, {'type': 'SECONDARY', 'title': 'FEF 25-75% (L/Sec)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Drug', 'description': 'N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG000', 'lowerLimit': '-0.39', 'upperLimit': '0.88'}, {'value': '-0.13', 'groupId': 'OG001', 'lowerLimit': '-1.22', 'upperLimit': '0.39'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to end of study (24 weeks)', 'description': 'Difference in mid-expiratory flow rates between 25 to 75% of the vital capacity, in L/sec measured at the beginning of the study to the end of the study.', 'unitOfMeasure': 'L/sec', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Out of 70 subjects randomized, 65 completed the Week 12 visit and 62 completed the study. There were 6 withdrawals in the NAC group and 2 in Placebo. Five out of 6 subjects in the NAC group withdrew due to subject decision. Missing data was not imputed.'}, {'type': 'SECONDARY', 'title': 'FEF 25-75% (Percent of Predicted)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Drug', 'description': 'N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.33', 'groupId': 'OG000', 'lowerLimit': '-16.46', 'upperLimit': '25.32'}, {'value': '-3.81', 'groupId': 'OG001', 'lowerLimit': '-25.20', 'upperLimit': '9.78'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 24 weeks', 'description': 'Difference in the forced expiratory flow rate in mid-exhalation as a percent of predicted to standard values measured from baseline to the end of study (24 weeks).', 'unitOfMeasure': 'percent of predicted', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Out of 70 subjects randomized, 65 completed the Week 12 visit and 62 completed the study. There were 6 withdrawals in the NAC group and 2 in Placebo. Five out of 6 subjects in the NAC group withdrew due to subject decision. Missing data was not imputed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in DLCO (ml/Min/mmHg) Over Time by Treatment Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Drug', 'description': 'N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.32', 'spread': '2.86', 'groupId': 'OG000', 'lowerLimit': '-4.76'}, {'value': '-1.39', 'spread': '3.93', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 24 weeks', 'description': 'Change in the diffusing capacity of carbon monoxide across the lung measured from baseline to end of 24-week study.', 'unitOfMeasure': 'ml/min/mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Sixteen subjects at Stanford University were enrolled as an initial safety cohort, and their data was used to evaluate the potential for NAC to cause PH in CF subjects.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in ECHO Tricuspid Regurgitation (mm Hg) Over Time by Treatment Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Drug', 'description': 'N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)'}], 'classes': [{'categories': [{'measurements': [{'value': '31.5', 'spread': '6.02', 'groupId': 'OG000'}, {'value': '31.75', 'spread': '5.84', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 24 weeks', 'description': 'Change in measure of estimated right ventricular pressure over the 24-week study period', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Sixteen subjects at Stanford University were enrolled as an initial safety cohort, and their data was used to evaluate the potential for NAC to cause PH in CF subjects. 1 subject in NAC cohort has missing data. It was not imputed'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Study Drug', 'description': 'N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Recruitment began 11/4/2008. Recruitment process was staggered: Stanford cohort first to focus on safety data related to potential pulmonary hypertension. After half of the Stanford cohort reached the 8-week time point, the DSMC evaluated PH safety data. The other sites then began enrollment. Final subject enrolled on 2/2011.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Study Drug', 'description': 'N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-15', 'studyFirstSubmitDate': '2008-12-15', 'resultsFirstSubmitDate': '2013-02-14', 'studyFirstSubmitQcDate': '2008-12-15', 'lastUpdatePostDateStruct': {'date': '2013-04-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-02-14', 'studyFirstPostDateStruct': {'date': '2008-12-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in DLCO (ml/Min/mmHg) Over Time by Treatment Group', 'timeFrame': 'Baseline to 24 weeks', 'description': 'Change in the diffusing capacity of carbon monoxide across the lung measured from baseline to end of 24-week study.'}, {'measure': 'Change in ECHO Tricuspid Regurgitation (mm Hg) Over Time by Treatment Group', 'timeFrame': 'Baseline to 24 weeks', 'description': 'Change in measure of estimated right ventricular pressure over the 24-week study period'}], 'primaryOutcomes': [{'measure': 'Change in the Logarithm of the Level of Human Neutrophil Elastase (HNE) Activity Measured in Sputum', 'timeFrame': 'From enrollment to end of the 24-week trial', 'description': '(change in log10 HNE in the active treatment group) - (change in log10 HNE in the placebo group)'}], 'secondaryOutcomes': [{'measure': 'Change in FEV1 (Percent of Predicted for Age)', 'timeFrame': 'From enrollment to the end of the 24-week trial', 'description': 'Change in forced expiratory volume in 1 second as compared to normals for age (percent of predicted)'}, {'measure': 'FEV1 (L)', 'timeFrame': 'Baseline to end of study (24 weeks)', 'description': 'Forced expiratory volume in 1 second (Liters)'}, {'measure': 'FEF 25-75% (L/Sec)', 'timeFrame': 'Baseline to end of study (24 weeks)', 'description': 'Difference in mid-expiratory flow rates between 25 to 75% of the vital capacity, in L/sec measured at the beginning of the study to the end of the study.'}, {'measure': 'FEF 25-75% (Percent of Predicted)', 'timeFrame': 'Baseline to 24 weeks', 'description': 'Difference in the forced expiratory flow rate in mid-exhalation as a percent of predicted to standard values measured from baseline to the end of study (24 weeks).'}]}, 'conditionsModule': {'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': 'This Phase IIB proof-of-concept study would examine the effects of an investigational product called N-acetylcysteine (NAC) on the basic processes that cause inflammation in CF lung disease. We hope to learn more about the causes of lung disease in cystic fibrosis by studying the characteristics of the inflammation in the lungs of patients who have CF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female 7 years of age or older\n2. Diagnosis of CF based upon the following criteria:\n\n 1. One or more clinical features characteristic of CF AND (b or c)\n 2. Positive sweat test \\> 60 mEq/L by quantitative pilocarpine iontophoresis\n 3. A genotype with two identifiable mutations consistent with CF\n3. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative\n4. Clinically stable with no evidence of acute upper or lower respiratory tract infection within 4 weeks prior to enrollment\n5. Stable mild or moderately severe lung disease defined by an FEV1 \\> or = 40% and \\< or = 85% predicted for age based on the Wang (males \\< 18 years, females \\< 16 years) or Hankinson (males \\> or = 18 years, females \\> or = 16 years) standardized equations\n6. Able to tolerate sputum induction with 3% hypertonic saline and to expectorate\n7. Able to perform repeatable, consistent efforts in pulmonary function testing\n8. Weight \\> or = 25 kg at time of enrollment\n9. Females of child bearing potential must be willing to use birth control (IUD, oral, transdermal, or parenteral contraceptives; abstinence)\n\nExclusion Criteria:\n\n1. Clinically significant liver enzymes (AST, ALT or GGT) \\> 2.5 times the upper limit of normal at screening\n2. History of ABPA, unless have evidence of a stable IgE (\\< 5% increase compared to previous test) for 6 months prior to enrollment\n3. Current or history of rheumatic or collagen vascular disorders\n4. Use of NSAIDS other than for chronic therapy within 1 week prior to enrollment\n5. Initiation of chronic therapy with ibuprofen, azithromycin, TOBI® or Aztreonam within 6 weeks prior to enrollment\n6. Consumption or inhalation of antioxidants (including NAC, GSH, Immunocal, Nacystelyn, pentoxyfilline) within 6 weeks prior to enrollment\n7. Use of oral or IV corticosteroids within 4 weeks prior to enrollment\n8. Use of acetaminophen within 3 days prior to enrollment\n9. Unable to forego during the study:\n\n * Vitamin E: more than 400 IU/day for subjects \\< or = 12 years of age and 800 IU/day for subjects \\> 12 years of age\n * Vitamin C: more than 0.5 gm/day\n * More than two alcoholic drinks per day\n10. Known hypersensitivity to oral PharmaNAC®\n11. Current cigarette consumption\n12. Pregnant or breastfeeding\n13. Subject unlikely to complete the study as determined by the Investigator\n14. Any condition that the Investigator believes would interfere with the intent of this study or would make participation not in the best interest of the subject\n15. Participation in trials for other anti-inflammatory or therapeutic investigational drugs within 6 weeks prior to enrollment"}, 'identificationModule': {'nctId': 'NCT00809094', 'briefTitle': 'NAC Phase IIB: A Multi-Center, Phase IIB, Randomized, Placebo-controlled, Double-Blind Study Of The Effects Of N-Acetylcysteine On Redox Changes and Lung Inflammation In Cystic Fibrosis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'A Multi-Center, Phase IIB, Randomized, Placebo-controlled, Double-Blind Study Of The Effects Of N-Acetylcysteine On Redox Changes and Lung Inflammation In Cystic Fibrosis Patients', 'orgStudyIdInfo': {'id': 'SU-12112008-1378'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo was administered oral tablet TID for 24 weeks.', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'N-Acetylcysteine', 'description': 'Participants received 900 mg of oral N-acetylcysteine TID for 24 weeks.', 'interventionNames': ['Drug: N-acetylcysteine (NAC)']}], 'interventions': [{'name': 'N-acetylcysteine (NAC)', 'type': 'DRUG', 'otherNames': ['PharmaNAC'], 'armGroupLabels': ['N-Acetylcysteine']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'National Jewish Hospital', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Shands at the University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Ctr', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Children', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'The PennState Milton S Hersey Medical Ctr', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'The Children', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Children', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah, Primary Children', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Carol K. Conrad', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cystic Fibrosis Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}