Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2025-12-25 @ 2:08 PM
Study NCT ID:
NCT00254566
Status:
COMPLETED
Last Update Posted:
2009-11-11
First Post:
2005-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Trial To Evaluate Two Antibiotics For The Treatment Of Acute Exacerbation Of Chronic Bronchitis (AECB)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029481', 'term': 'Bronchitis, Chronic'}], 'ancestors': [{'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077266', 'term': 'Moxifloxacin'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'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': {'email': 'ClinicalTrials.govCallCenter@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of \\<60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \\<12 mo from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Azithromycin', 'description': 'Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1', 'otherNumAffected': 32, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Moxifloxacin', 'description': 'Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.', 'otherNumAffected': 19, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoxic Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sudden Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lung Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Clinical Cure (Success) at Test of Cure Visit(Clinical Per Protocol Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '187', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin', 'description': 'Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1'}, {'id': 'OG001', 'title': 'Moxifloxacin', 'description': 'Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.'}], 'classes': [{'title': 'Cure', 'categories': [{'measurements': [{'value': '93.0', 'groupId': 'OG000'}, {'value': '94.2', 'groupId': 'OG001'}]}]}, {'title': 'Failure', 'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000'}, {'value': '5.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-5.8', 'ciUpperLimit': '3.9', 'estimateComment': 'Risk difference is the difference in percentage of participants with cure and the 95% Confidence Interval', 'groupDescription': '95% Confidence Interval (CI) for the difference in cure rates will be constructed using a method of linear stratification that weights according to the reciporcal of the variance. Stratification will be by steriod use at time of randomization.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority will be declared if the lower bound of the 95% CI around the difference in clinical success rates is greater than -10%'}], 'paramType': 'NUMBER', 'timeFrame': 'Test of Cure (TOC) Visit (Day 12-19)', 'description': 'Cure=Signs\\&symptoms(S\\&S) of infection return to normal baseline level or clin improvement requiring no other antibiotics(AB); Failure=other AB due to S\\&S of acute infection persisted/worsened,new clinical S\\&S of acute infection,or clinical/radiological evidence of pneumonia developed during treatment; percent = # of cure or failure/total # of sub', 'unitOfMeasure': 'percent', 'reportingStatus': 'POSTED', 'populationDescription': 'Clinical Per Protocol-all randomized subjects who were clinically eligible; received at least 80% of study med; no concomitant systemic antibiotics with activity against Acute Exacerbation of Chronic Bronchitis (AECB) pathogens, assessment made in appropriate visit window.'}, {'type': 'SECONDARY', 'title': 'Percentage of Clinical Cure (Success) at Test of Cure Visit (Full Analysis Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin', 'description': 'Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1'}, {'id': 'OG001', 'title': 'Moxifloxacin', 'description': 'Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.'}], 'classes': [{'title': 'Cure', 'categories': [{'measurements': [{'value': '88.4', 'groupId': 'OG000'}, {'value': '90.9', 'groupId': 'OG001'}]}]}, {'title': 'Failure', 'categories': [{'measurements': [{'value': '11.6', 'groupId': 'OG000'}, {'value': '9.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciPctValue': '95', 'paramValue': '-2.5', 'ciLowerLimit': '-8.5', 'ciUpperLimit': '3.4', 'estimateComment': 'Risk difference is the difference in the percentage of participants with Cure and the 95% CI', 'groupDescription': '95% CI for the difference in cure rates will be constructed using a method of linear stratification that weights according to the reciporcal of the variance. Stratification will be by steriod use at time of randomization.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority will be declared if the lower bound of the 95% CI around the difference in clinical success rates is greater than -10%'}], 'paramType': 'NUMBER', 'timeFrame': 'Test of Cure (TOC) Visit (Day 12-19)', 'description': 'Clinical response (Cure vs Failure) at the TOC visit for the Full Analysis Set (FAS), Cure=Signs\\&symptoms(S\\&S) of infection return to normal baseline level or clin improvement requiring no other antibiotics(AB); Failure=other AB due to S\\&S of acute infection persisted/worsened,new clinical S\\&S of acute infection,or clinical/radiological evidence of pneumonia developed during treatment; percent = # of cure or failure/total # of sub', 'unitOfMeasure': 'Percent', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) is all randomized subjects who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Percentage of Clinical Cure (Success)at Test of Cure Visit(Clinically Eligible Set)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin', 'description': 'Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1'}, {'id': 'OG001', 'title': 'Moxifloxacin', 'description': 'Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.'}], 'classes': [{'title': 'Cure', 'categories': [{'measurements': [{'value': '88.4', 'groupId': 'OG000'}, {'value': '90.9', 'groupId': 'OG001'}]}]}, {'title': 'Failure', 'categories': [{'measurements': [{'value': '11.6', 'groupId': 'OG000'}, {'value': '9.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciPctValue': '95', 'paramValue': '-2.5', 'ciLowerLimit': '-8.5', 'ciUpperLimit': '3.4', 'estimateComment': 'Risk difference is the difference in percentage of participants with cure and the 95% Confidence', 'groupDescription': '95% CI for the difference in cure rates will be constructed using a method of linear stratification that weights according to the reciprocal of the variance. Stratification will be by steroid use at time of randomization.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority will be declared if the lower bound of the 95% CI around the difference in clinical success rates is greater than -10%'}], 'paramType': 'NUMBER', 'timeFrame': 'Test of Cure (TOC) Visit (Day 12-19)', 'description': 'Clinical Response at TOC Visit for clinically Eligible Subjects, Cure=Signs\\&symptoms(S\\&S) of infection return to normal baseline level or clin improvement requiring no other antibiotics(AB); Failure=other AB due to S\\&S of acute infection persisted/worsened,new clinical S\\&S of acute infection,or clinical/radiological evidence of pneumonia developed during treatment; percent = # of cure or failure/total # of sub', 'unitOfMeasure': 'Percent', 'reportingStatus': 'POSTED', 'populationDescription': 'Clinically eligible compromised of subjects from FAS with diagnosis of chronic bronchitis, clinical evidence of AECB based on S\\&S, \\& a neg chest radiograph for pneumonia based on radiologist opinion'}, {'type': 'SECONDARY', 'title': 'Percentage of Bacteriologic Response at Test of Cure Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin', 'description': 'Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1'}, {'id': 'OG001', 'title': 'Moxifloxacin', 'description': 'Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.'}], 'classes': [{'title': 'Eradication', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '96.7', 'groupId': 'OG001'}]}]}, {'title': 'Persistence', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-4.5', 'ciUpperLimit': '3.3', 'estimateComment': 'Risk difference is the difference in eradication rates of pathogens by treatment', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Test of Cure (TOC) Visit (Day 12-19)', 'description': 'Bacteriogical response assessed on per pathogen basis for Bacteriologic Per Protcol (BPP) set at TOC Visit. If no repeat culture, response is presumed from sponsor assessment of clinical response. Eradication =# of pathogens eradicated at TOC/N; Persistence =# of pathogens persistent at TOC/N; N=# of unique pathogens identified at baseline', 'unitOfMeasure': 'Percent', 'reportingStatus': 'POSTED', 'populationDescription': 'Bacteriologic per protocol set is compromised of subjects from the Clinical Per Protocol set with a baseline bacterial pathogen. The number of participants is the number of unique pathogens identified at baseline.'}, {'type': 'SECONDARY', 'title': 'Time Taken for First Quartile (25%) of Subjects to Have AECB Recurrence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin', 'description': 'Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1'}, {'id': 'OG001', 'title': 'Moxifloxacin', 'description': 'Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.'}], 'classes': [{'categories': [{'measurements': [{'value': '152', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.159', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciPctValue': '95', 'paramValue': '1.33', 'ciLowerLimit': '0.9', 'ciUpperLimit': '2.0', 'pValueComment': "p-value was estimated from Cox's Proportional Hazard model with steriod use and country as factors and baseline FEV1 fitted as covariate", 'groupDescription': "Kaplan-Meier method was used to estimate time taken for 1st 25th quartile of subjects to experience recurrence of AECB. Estimate of median time to event couldn't be calculated because \\<50% of subjects in analysis population experienced a recurrence. The ratio of the treatment groups' recurrence rate (hazard ratio) estimated using Cox proportional hazards model adjusting for steroid use, frequency of AECB in previous 12 months, country and baseline Forced expiratory volume in 1 second (FEV1).", 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Number of Days', 'description': 'Subject is considered to have AECB recurrence if they had a clinical response of cure at the TOC visit and then met the definition of AECB during the follow-up period.', 'unitOfMeasure': 'Days', 'reportingStatus': 'POSTED', 'populationDescription': 'Time to AECB recurrence will be analyzed for the FAS using survival analysis methods to account for censored observations. Subjects are censored at the date last known to have not experienced a recurrence. Median time to recurrence will be estimated using the Kaplan-Meier method.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Clinical COPD Questionnaire(CCQ)Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin', 'description': 'Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1'}, {'id': 'OG001', 'title': 'Moxifloxacin', 'description': 'Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.76', 'spread': '0.112', 'groupId': 'OG000'}, {'value': '-0.71', 'spread': '0.106', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.57', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.21', 'ciUpperLimit': '0.12', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Estimated from ANCOVA with treatment, steriod use, and country fitted as factor and baseline CCQ total scores and FEV1 fitted as covariates', 'testedNonInferiority': False}, {'pValue': '0.82', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.13', 'ciUpperLimit': '0.10', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Estimated from linear mixed model with treatment, steroid use, FEV1, country and time point as factors and baseline CCQ scores as a covariate', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Test of Cure (TOC) Visit (Day 12-19)', 'description': 'CCQ was developed to measure health status of Chronic obstructive pulmonary disease (COPD) subjects. 10 items divided into 3 domains: symtoms, functional state, and mental state. Subject record their experiences during last 24 hrs. 7 pt scale - 0=asymptomatic and 6=extremely symptomatic/totally limited; change=mean score at observation minus mean score at baseline', 'unitOfMeasure': 'Score on Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis on Full Analysis Set, Last Observation Carried Forward (LOCF)-missing values at TOC visit will be imputed by carrying forward the last post-baseline observation; total score calculated by deriving the simple average of relevant items, total score is set to missing if 1 or more domain scales cannot be derived.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Clinical COPD Questionnaire(CCQ)Symptoms Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin', 'description': 'Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1'}, {'id': 'OG001', 'title': 'Moxifloxacin', 'description': 'Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.99', 'spread': '0.129', 'groupId': 'OG000'}, {'value': '-0.96', 'spread': '0.122', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.81', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.21', 'ciUpperLimit': '0.17', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Estimated from ANCOVA with treatment, steriod use and country fitted as factors and baseline CCQ total score and FEV1 fitted as covariates', 'testedNonInferiority': False}, {'pValue': '0.87', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.12', 'ciUpperLimit': '0.14', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Estimated from linear mixed model with treatment, steroid use, FEV1, country and time point as factors and baseline CCQ scores as a covariate', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Test of Cure (TOC) Visit (Day 12-19)', 'description': '1 of 3 domains that combined into the CCQ Total score. Items 1,2,5,and 6 address symptoms. Subject record their experiences during last 24 hrs. 7 pt scale - 0=asymptomatic and 6=extremely symptomatic; change=mean score at observation minus mean score at baseline', 'unitOfMeasure': 'Score on Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis on Full Analysis Set, LOCF - missing values at the TOC visit will be imputed by carrying forward the last post baseline observation. Domain score is calculated by deriving the simple average of the relevant items, at least 75% of items must be non-missing to derive the domain score'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Clinical COPD Questionnaire(CCQ)Functional State Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Azithromycin', 'description': 'Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1'}, {'id': 'OG001', 'title': 'Moxifloxacin', 'description': 'Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.61', 'spread': '0.127', 'groupId': 'OG000'}, {'value': '-0.52', 'spread': '0.120', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.385', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.27', 'ciUpperLimit': '0.10', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Estimated from ANCOVA with treatment, steriod use and country fitted as factors and baseline CCQ total score and FEV1 fitted as covariates', 'testedNonInferiority': False}, {'pValue': '0.56', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.17', 'ciUpperLimit': '0.09', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Estimated from linear mixed model with treatment, steroid use, FEV1, country and time point as factors and baseline CCQ scores as a covariate', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Test of Cure (TOC) Visit (Day 12-19)', 'description': '1 of 3 domains that combined into the CCQ Total score. Items 7,8,9, and 10 address functional state. Subject record their experiences during last 24 hrs. 7 pt scale - 0=asymptomatic and 6=extremely; change=mean score at observation minus mean score at baseline', 'unitOfMeasure': 'Score on Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis on Full Analysis Set, LOCF-missing values at the TOC visit will be imputed by carrying forward the last post baseline observation. 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Two subjects who were assigned to moxifloxacin did not receive at least one dose of treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '396', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Azithromycin', 'description': 'Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1'}, {'id': 'BG001', 'title': 'Moxifloxacin', 'description': 'Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.7', 'spread': '8.7', 'groupId': 'BG000'}, {'value': '67.5', 'spread': '8.5', 'groupId': 'BG001'}, {'value': '67.1', 'spread': '8.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '39.0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '180', 'groupId': 'BG000'}, {'value': '177', 'groupId': 'BG001'}, {'value': '357.0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 398}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-11-03', 'studyFirstSubmitDate': '2005-11-14', 'resultsFirstSubmitDate': '2009-07-22', 'studyFirstSubmitQcDate': '2005-11-14', 'lastUpdatePostDateStruct': {'date': '2009-11-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-07-22', 'studyFirstPostDateStruct': {'date': '2005-11-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Clinical Cure (Success) at Test of Cure Visit(Clinical Per Protocol Population)', 'timeFrame': 'Test of Cure (TOC) Visit (Day 12-19)', 'description': 'Cure=Signs\\&symptoms(S\\&S) of infection return to normal baseline level or clin improvement requiring no other antibiotics(AB); Failure=other AB due to S\\&S of acute infection persisted/worsened,new clinical S\\&S of acute infection,or clinical/radiological evidence of pneumonia developed during treatment; percent = # of cure or failure/total # of sub'}], 'secondaryOutcomes': [{'measure': 'Percentage of Clinical Cure (Success) at Test of Cure Visit (Full Analysis Set)', 'timeFrame': 'Test of Cure (TOC) Visit (Day 12-19)', 'description': 'Clinical response (Cure vs Failure) at the TOC visit for the Full Analysis Set (FAS), Cure=Signs\\&symptoms(S\\&S) of infection return to normal baseline level or clin improvement requiring no other antibiotics(AB); Failure=other AB due to S\\&S of acute infection persisted/worsened,new clinical S\\&S of acute infection,or clinical/radiological evidence of pneumonia developed during treatment; percent = # of cure or failure/total # of sub'}, {'measure': 'Percentage of Clinical Cure (Success)at Test of Cure Visit(Clinically Eligible Set)', 'timeFrame': 'Test of Cure (TOC) Visit (Day 12-19)', 'description': 'Clinical Response at TOC Visit for clinically Eligible Subjects, Cure=Signs\\&symptoms(S\\&S) of infection return to normal baseline level or clin improvement requiring no other antibiotics(AB); Failure=other AB due to S\\&S of acute infection persisted/worsened,new clinical S\\&S of acute infection,or clinical/radiological evidence of pneumonia developed during treatment; percent = # of cure or failure/total # of sub'}, {'measure': 'Percentage of Bacteriologic Response at Test of Cure Visit', 'timeFrame': 'Test of Cure (TOC) Visit (Day 12-19)', 'description': 'Bacteriogical response assessed on per pathogen basis for Bacteriologic Per Protcol (BPP) set at TOC Visit. 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