Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2025-12-29 @ 3:26 PM
Study NCT ID:
NCT01255592
Status:
COMPLETED
Last Update Posted:
2015-10-08
First Post:
2010-12-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the Effect of AZD5069 in Patients With Bronchiectasis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001987', 'term': 'Bronchiectasis'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000597960', 'term': 'N-(2-(2,3-difluoro-6-benzylthio)-6-(3,4-dihydroxybutan-2-yloxy)pyrimidin-4-yl)azetidine-1-sulfonamide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aztrial_results_posting@astrazeneca.com', 'title': 'Gerard Lynch', 'organization': 'AstraZeneca'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'AZD5069', 'description': '80 mg bd', 'otherNumAtRisk': 26, 'otherNumAffected': 22, 'seriousNumAtRisk': 26, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo for AZD5069 bd', 'otherNumAtRisk': 26, 'otherNumAffected': 16, 'seriousNumAtRisk': 26, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Non-Cardiac Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Infective Exacerbation Of Bronchiectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Musculoskeletal Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pain In Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'seriousEvents': [{'term': 'Infective Exacerbation Of Bronchiectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Ratio of Absolute Neutrophil Cell Count in Sputum at End of Treatment Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD5069', 'description': 'AZD5069 80 mg bd'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo bd'}], 'classes': [{'categories': [{'measurements': [{'value': '0.31', 'spread': '165.925', 'groupId': 'OG000', 'lowerLimit': '0.20', 'upperLimit': '0.50'}, {'value': '1.00', 'spread': '213.281', 'groupId': 'OG001', 'lowerLimit': '0.66', 'upperLimit': '1.51'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of AZD5069 80 mg to placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.31', 'ciLowerLimit': '0.17', 'ciUpperLimit': '0.59', 'groupDescription': 'Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection, and baseline as covariates. The analysis was done on log-transformed data. The results were back-transformed after the analysis on the log scale.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.', 'description': 'Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.', 'unitOfMeasure': 'ratio', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).'}, {'type': 'SECONDARY', 'title': 'Ratio of the Percentage Neutrophil Cell Count in Sputum at End of Treatment Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD5069', 'description': 'AZD5069 80 mg bd'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for AZD5069, bd'}], 'classes': [{'categories': [{'measurements': [{'value': '0.66', 'spread': '29.746', 'groupId': 'OG000', 'lowerLimit': '0.54', 'upperLimit': '0.80'}, {'value': '1.02', 'spread': '56.883', 'groupId': 'OG001', 'lowerLimit': '0.86', 'upperLimit': '1.22'}]}]}], 'analyses': [{'pValue': '0.008', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of AZD5069 80 mg to placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.64', 'ciLowerLimit': '0.49', 'ciUpperLimit': '0.84', 'groupDescription': 'Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection, and baseline as covariates. The analysis was done on log-transformed data. The results were back-transformed after the analysis on the log scale.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.', 'description': 'Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.', 'unitOfMeasure': 'ratio', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Weight of 24-hour Sputum Collection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD5069', 'description': 'AZD5069 80 mg bd'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for AZD5069, bd'}], 'classes': [{'categories': [{'measurements': [{'value': '3.51', 'spread': '2.455', 'groupId': 'OG000'}, {'value': '-3.26', 'spread': '2.195', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.047', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '6.78', 'ciLowerLimit': '1.22', 'ciUpperLimit': '12.33', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.298', 'groupDescription': 'The 24-hour sputum weight on Visit 4 was compared between groups using ANCOVA (additive model) with treatment and inhaled corticosteroids/P. aeruginosa infection as fixed effects and baseline as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and end of treatment (Day 28)', 'description': 'Patients collected all sputum produced during a 24-hour period at baseline and Day 28.', 'unitOfMeasure': 'grams', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Slow Vital Capacity (SVC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD5069', 'description': 'AZD5069 80 mg bd'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for AZD5069, bd'}], 'classes': [{'categories': [{'measurements': [{'value': '0.05', 'spread': '0.067', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '0.063', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.284', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.10', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.26', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.092', 'groupDescription': 'Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to end of treatment (Day 28)', 'description': 'Lung function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. SVC is the measure of the change in volume of gas in the lungs from complete inspiration to complete expiration.', 'unitOfMeasure': 'liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Forced Vital Capacity (FVC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD5069', 'description': 'AZD5069 80 mg bd'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for AZD5069, bd'}], 'classes': [{'categories': [{'measurements': [{'value': '0.07', 'spread': '0.056', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.054', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.929', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.01', 'ciLowerLimit': '-0.12', 'ciUpperLimit': '0.14', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.078', 'groupDescription': 'Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to end of treatment (Day 28)', 'description': 'Lung function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FVC is the maximum volume of air which can be exhaled or inspired during a forced maneuver.', 'unitOfMeasure': 'liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD5069', 'description': 'AZD5069 80 mg bd'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for AZD5069, bd'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.044', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.043', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.966', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.00', 'ciLowerLimit': '-0.11', 'ciUpperLimit': '0.10', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.062', 'groupDescription': 'Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to end of treatment (Day 28)', 'description': 'Lung function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FEV1 is the volume expired in the first second of maximal expiration after a full inspiration.', 'unitOfMeasure': 'liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Forced Expiratory Flow Between 25% and 75% of Forced Vital Capacity (FEF25-75)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD5069', 'description': 'AZD5069 80 mg bd'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for AZD5069, bd'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.063', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '0.062', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.791', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.02', 'ciLowerLimit': '-0.13', 'ciUpperLimit': '0.17', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.090', 'groupDescription': 'Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to end of treatment (Day 28)', 'description': 'Lung function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FEF25-75 is flow rate during the middle half of forced vital capacity (25%-75% of the total volume (FVC) exhaled).', 'unitOfMeasure': 'liters/second', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'Transition Dyspnea Index (TDI) at End of Treatment (Day 28)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD5069', 'description': 'AZD5069 80 mg bd'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for AZD5069, bd'}], 'classes': [{'categories': [{'measurements': [{'value': '-1', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '-0', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.433', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '0.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.7', 'groupDescription': 'The ANCOVA model used TDI as the response variable with treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and BDI as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to end of treatment (Day 28)', 'description': 'TDI measures changes in dyspnea severity from the baseline as established by the Baseline Dyspnea Index (BDI). TDI is an interviewer-administered rating of severity of dyspnea that assesses Change in Functional Impairment, Change in Magnitude of Task, and Change in Magnitude of Effort domains on a 7-point scale ranging from -3 (major deterioration) to +3 (major improvement). Total score ranges from -9 to +9. The lower the score, the more deterioration in severity of dyspnea.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline for the Morning PEF and Evening PEF of the Bronkotest Diary Card', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD5069', 'description': 'AZD5069 80 mg bd'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for AZD5069, bd'}], 'classes': [{'title': 'Morning PEF', 'categories': [{'measurements': [{'value': '-5.3', 'spread': '5.41', 'groupId': 'OG000'}, {'value': '-5.9', 'spread': '5.53', 'groupId': 'OG001'}]}]}, {'title': 'Evening PEF', 'categories': [{'measurements': [{'value': '-7.3', 'spread': '4.95', 'groupId': 'OG000'}, {'value': '-10.6', 'spread': '5.06', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.935', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.7', 'ciLowerLimit': '-12.81', 'ciUpperLimit': '14.13', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8.03', 'groupDescription': 'Morning PEF: Analysis of covariance includes treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.654', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '3.3', 'ciLowerLimit': '-9.02', 'ciUpperLimit': '15.64', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.35', 'groupDescription': 'Evening PEF: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Last 7 days on treatment', 'description': 'The Bronkotest diary card is a paper based diary card that was filled out by patients daily, recording values from morning and evening peak expiratory flow (PEF) measurements and answering 8 questions on signs and symptoms. Summary statistics for baseline (mean of the last 7 days prior to first dose) and change (mean of the last 7 days on treatment - baseline) only contain patients included in the analysis. For symptom scores a decrease is an improvement, for PEF an increase is an improvement.', 'unitOfMeasure': 'L/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline for the Symptom Scores of the Bronkotest Diary Card', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD5069', 'description': 'AZD5069 80 mg bd'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for AZD5069, bd'}], 'classes': [{'title': 'Describe your breathing', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.10', 'groupId': 'OG001'}]}]}, {'title': 'How often do you cough?', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Night time symptom score', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'What color is your sputum?', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.18', 'groupId': 'OG001'}]}]}, {'title': 'The amount of sputum you produced', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Type of sputum', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'How do you feel?', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '0.10', 'groupId': 'OG001'}]}]}, {'title': 'Number of puffs of inhalers', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.30', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.329', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.1', 'ciLowerLimit': '-0.09', 'ciUpperLimit': '0.36', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.14', 'groupDescription': 'Describe your breathing: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.664', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.1', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.27', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.13', 'groupDescription': 'How often do you cough?: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.152', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.3', 'ciLowerLimit': '-0.04', 'ciUpperLimit': '0.54', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.17', 'groupDescription': 'Night time symptom score: Analysis of covariance includes treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.150', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.4', 'ciLowerLimit': '-0.80', 'ciUpperLimit': '0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.25', 'groupDescription': 'What color is your sputum?: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.248', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.1', 'ciLowerLimit': '-0.06', 'ciUpperLimit': '0.35', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.12', 'groupDescription': 'The amount of sputum you produced: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.053', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.2', 'ciLowerLimit': '-0.45', 'ciUpperLimit': '-0.04', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.12', 'groupDescription': 'Type of sputum: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.179', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.2', 'ciLowerLimit': '-0.04', 'ciUpperLimit': '0.42', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.14', 'groupDescription': 'How do you feel?: Analysis of covariance includes treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.942', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.0', 'ciLowerLimit': '-0.75', 'ciUpperLimit': '0.68', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.43', 'groupDescription': 'Number of puffs of inhalers: Analysis of covariance includes treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Last 7 days on treatment', 'description': 'The Bronkotest diary card is a paper based diary card that was filled out by patients daily, recording values from morning and evening peak expiratory flow (PEF) measurements and answering 8 questions on signs and symptoms. Symptom scores were recorded for night-time symptoms, breathing, sputum colour, sputum amount, sputum type, wellbeing, number of puffs of inhalers, and cough, generally scored on a scale from 0 (no symptoms) to 4 (worst symptoms). Summary statistics for baseline (mean of the last 7 days prior to first dose) and change (mean of the last 7 days on treatment - baseline) only contain patients included in the analysis. For symptom scores a decrease is an improvement, for PEF an increase is an improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': "Change From Baseline Total and Domain Scores in St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD5069', 'description': 'AZD5069 80 mg bd'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for AZD5069, bd'}], 'classes': [{'title': 'Total score', 'categories': [{'measurements': [{'value': '-1.75', 'spread': '2.402', 'groupId': 'OG000'}, {'value': '-0.09', 'spread': '2.355', 'groupId': 'OG001'}]}]}, {'title': 'Symptom domain', 'categories': [{'measurements': [{'value': '-3.16', 'spread': '2.356', 'groupId': 'OG000'}, {'value': '1.72', 'spread': '2.309', 'groupId': 'OG001'}]}]}, {'title': 'Activity domain', 'categories': [{'measurements': [{'value': '-0.46', 'spread': '3.216', 'groupId': 'OG000'}, {'value': '0.85', 'spread': '3.153', 'groupId': 'OG001'}]}]}, {'title': 'Impact domain', 'categories': [{'measurements': [{'value': '-1.83', 'spread': '2.742', 'groupId': 'OG000'}, {'value': '-1.45', 'spread': '2.689', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.625', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.66', 'ciLowerLimit': '-7.32', 'ciUpperLimit': '4.00', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.374', 'groupDescription': 'Total score: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.151', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-4.88', 'ciLowerLimit': '-10.49', 'ciUpperLimit': '0.74', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.342', 'groupDescription': 'Symptom domain: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.773', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.31', 'ciLowerLimit': '-8.91', 'ciUpperLimit': '6.28', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.524', 'groupDescription': 'Activity domain: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.920', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.39', 'ciLowerLimit': '-6.84', 'ciUpperLimit': '6.07', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.845', 'groupDescription': 'Impact domain: Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and end of treatment (Day 28)', 'description': "SGRQ-C total score shows the impact of COPD on patient's health status, and expressed as a percentage of impairment with scale from 0 (best health status) to 100 (worst possible status). The SGRQ-C contains 3 domains:\n\nSymptom (distress due to respiratory symptoms), Activity (disturbance of physical activity) and Impact (overall impact on daily life and well being). All three domains with scale from 0 (best health status) to 100 (worst possible status).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis set included all patients who were randomized (defined as having a randomization code recorded on the demography case report form), received at least one dose of study medication, and contributed sufficient data for at least one efficacy endpoint.'}, {'type': 'SECONDARY', 'title': 'Ratio of Interleukin-1 Beta (IL-1β) in Sputum at End of Treatment Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD5069', 'description': 'AZD5069 80 mg bd'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for AZD5069, bd'}], 'classes': [{'categories': [{'measurements': [{'value': '0.63', 'groupId': 'OG000', 'lowerLimit': '0.44', 'upperLimit': '0.90'}, {'value': '0.91', 'groupId': 'OG001', 'lowerLimit': '0.65', 'upperLimit': '1.28'}]}]}], 'analyses': [{'pValue': '0.220', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.69', 'ciLowerLimit': '0.42', 'ciUpperLimit': '1.14', 'groupDescription': 'Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.', 'description': 'Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.', 'unitOfMeasure': 'ratio', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).'}, {'type': 'SECONDARY', 'title': 'Ratio of Interleukin-6 (IL-6) in Sputum at End of Treatment Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD5069', 'description': 'AZD5069 80 mg bd'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for AZD5069, bd'}], 'classes': [{'categories': [{'measurements': [{'value': '3.68', 'groupId': 'OG000', 'lowerLimit': '2.79', 'upperLimit': '4.84'}, {'value': '0.82', 'groupId': 'OG001', 'lowerLimit': '0.64', 'upperLimit': '1.07'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '4.46', 'ciLowerLimit': '3.05', 'ciUpperLimit': '6.54', 'groupDescription': 'Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.', 'description': 'Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.', 'unitOfMeasure': 'ratio', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).'}, {'type': 'SECONDARY', 'title': 'Ratio of Regulated on Activation, Normal T Cell Expressed and Secreted (RANTES) in Sputum at End of Treatment Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD5069', 'description': 'AZD5069 80 mg bd'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for AZD5069, bd'}], 'classes': [{'categories': [{'measurements': [{'value': '0.99', 'groupId': 'OG000', 'lowerLimit': '0.79', 'upperLimit': '1.24'}, {'value': '1.07', 'groupId': 'OG001', 'lowerLimit': '0.87', 'upperLimit': '1.32'}]}]}], 'analyses': [{'pValue': '0.670', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.92', 'ciLowerLimit': '0.68', 'ciUpperLimit': '1.26', 'groupDescription': 'Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.', 'description': 'Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.', 'unitOfMeasure': 'ratio', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).'}, {'type': 'SECONDARY', 'title': 'Ratio of Monocyte Chemoattractant Protein-1 (MCP-1) in Sputum at End of Treatment Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD5069', 'description': 'AZD5069 80 mg bd'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for AZD5069, bd'}], 'classes': [{'categories': [{'measurements': [{'value': '0.91', 'groupId': 'OG000', 'lowerLimit': '0.77', 'upperLimit': '1.09'}, {'value': '0.92', 'groupId': 'OG001', 'lowerLimit': '0.78', 'upperLimit': '1.08'}]}]}], 'analyses': [{'pValue': '0.968', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.99', 'ciLowerLimit': '0.78', 'ciUpperLimit': '1.27', 'groupDescription': 'Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.', 'description': 'Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.', 'unitOfMeasure': 'ratio', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).'}, {'type': 'SECONDARY', 'title': 'Ratio of Tumor Necrosis Factor Alpha (TNF-α) in Sputum at End of Treatment Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD5069', 'description': 'AZD5069 80 mg bd'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for AZD5069, bd'}], 'classes': [{'categories': [{'measurements': [{'value': '1.29', 'groupId': 'OG000', 'lowerLimit': '0.93', 'upperLimit': '1.80'}, {'value': '0.91', 'groupId': 'OG001', 'lowerLimit': '0.67', 'upperLimit': '1.23'}]}]}], 'analyses': [{'pValue': '0.193', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.43', 'ciLowerLimit': '0.91', 'ciUpperLimit': '2.24', 'groupDescription': 'Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.', 'description': 'Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.', 'unitOfMeasure': 'ratio', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).'}, {'type': 'SECONDARY', 'title': 'Ratio of Growth-related Oncogene-α (GRO-α) in Sputum at End of Treatment Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD5069', 'description': 'AZD5069 80 mg bd'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for AZD5069, bd'}], 'classes': [{'categories': [{'measurements': [{'value': '2.77', 'groupId': 'OG000', 'lowerLimit': '2.08', 'upperLimit': '3.67'}, {'value': '0.85', 'groupId': 'OG001', 'lowerLimit': '0.65', 'upperLimit': '1.11'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '3.24', 'ciLowerLimit': '2.19', 'ciUpperLimit': '4.79', 'groupDescription': 'Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.', 'description': 'Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.', 'unitOfMeasure': 'ratio', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).'}, {'type': 'SECONDARY', 'title': 'Ratio of Interleukin-8 (IL-8) in Sputum at End of Treatment Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD5069', 'description': 'AZD5069 80 mg bd'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for AZD5069, bd'}], 'classes': [{'categories': [{'measurements': [{'value': '0.81', 'groupId': 'OG000', 'lowerLimit': '0.62', 'upperLimit': '1.07'}, {'value': '0.80', 'groupId': 'OG001', 'lowerLimit': '0.62', 'upperLimit': '1.02'}]}]}], 'analyses': [{'pValue': '0.917', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.02', 'ciLowerLimit': '0.71', 'ciUpperLimit': '1.48', 'groupDescription': 'Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.', 'description': 'Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.', 'unitOfMeasure': 'ratio', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).'}, {'type': 'SECONDARY', 'title': 'Ratio of Neutrophil Elastase Activity in Sputum at End of Treatment Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD5069', 'description': 'AZD5069 80 mg bd'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for AZD5069, bd'}], 'classes': [{'categories': [{'measurements': [{'value': '0.34', 'groupId': 'OG000', 'lowerLimit': '0.09', 'upperLimit': '1.28'}, {'value': '1.95', 'groupId': 'OG001', 'lowerLimit': '0.59', 'upperLimit': '6.39'}]}]}], 'analyses': [{'pValue': '0.111', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.17', 'ciLowerLimit': '0.03', 'ciUpperLimit': '1.08', 'groupDescription': 'Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.', 'description': 'Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.', 'unitOfMeasure': 'ratio', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).'}, {'type': 'SECONDARY', 'title': 'Ratio of Serum Amyloid A (SAA) in Serum at End of Treatment Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD5069', 'description': 'AZD5069 80 mg bd'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for AZD5069, bd'}], 'classes': [{'categories': [{'measurements': [{'value': '1.18', 'groupId': 'OG000', 'lowerLimit': '0.82', 'upperLimit': '1.72'}, {'value': '0.89', 'groupId': 'OG001', 'lowerLimit': '0.61', 'upperLimit': '1.29'}]}]}], 'analyses': [{'pValue': '0.367', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.33', 'ciLowerLimit': '0.79', 'ciUpperLimit': '2.26', 'groupDescription': 'Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.', 'description': 'Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.', 'unitOfMeasure': 'ratio', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).'}, {'type': 'SECONDARY', 'title': 'Ratio of C-reactive Protein (CRP) in Serum at End of Treatment Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD5069', 'description': 'AZD5069 80 mg bd'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for AZD5069, bd'}], 'classes': [{'categories': [{'measurements': [{'value': '1.28', 'groupId': 'OG000', 'lowerLimit': '0.94', 'upperLimit': '1.76'}, {'value': '0.83', 'groupId': 'OG001', 'lowerLimit': '0.61', 'upperLimit': '1.14'}]}]}], 'analyses': [{'pValue': '0.112', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.54', 'ciLowerLimit': '0.98', 'ciUpperLimit': '2.40', 'groupDescription': 'Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.', 'description': 'Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.', 'unitOfMeasure': 'ratio', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).'}, {'type': 'SECONDARY', 'title': 'Ratio of Tumor Necrosis Factor Alpha (TNF-α) in Serum at End of Treatment Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD5069', 'description': 'AZD5069 80 mg bd'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for AZD5069, bd'}], 'classes': [{'categories': [{'measurements': [{'value': '1.02', 'groupId': 'OG000', 'lowerLimit': '0.97', 'upperLimit': '1.06'}, {'value': '0.97', 'groupId': 'OG001', 'lowerLimit': '0.92', 'upperLimit': '1.02'}]}]}], 'analyses': [{'pValue': '0.241', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.05', 'ciLowerLimit': '0.98', 'ciUpperLimit': '1.12', 'groupDescription': 'Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.', 'description': 'Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.', 'unitOfMeasure': 'ratio', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).'}, {'type': 'SECONDARY', 'title': 'Ratio of Growth-related Oncogene-α (GRO-α) in Serum at End of Treatment Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD5069', 'description': 'AZD5069 80 mg bd'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for AZD5069, bd'}], 'classes': [{'categories': [{'measurements': [{'value': '5.45', 'groupId': 'OG000', 'lowerLimit': '4.42', 'upperLimit': '6.73'}, {'value': '0.99', 'groupId': 'OG001', 'lowerLimit': '0.84', 'upperLimit': '1.18'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '5.50', 'ciLowerLimit': '4.18', 'ciUpperLimit': '7.23', 'groupDescription': 'Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.', 'description': 'Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.', 'unitOfMeasure': 'ratio', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).'}, {'type': 'SECONDARY', 'title': 'Ratio of Interleukin-6 (IL-6) in Serum at End of Treatment Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD5069', 'description': 'AZD5069 80 mg bd'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for AZD5069, bd'}], 'classes': [{'categories': [{'measurements': [{'value': '1.13', 'groupId': 'OG000', 'lowerLimit': '0.96', 'upperLimit': '1.34'}, {'value': '0.97', 'groupId': 'OG001', 'lowerLimit': '0.82', 'upperLimit': '1.15'}]}]}], 'analyses': [{'pValue': '0.281', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.16', 'ciLowerLimit': '0.92', 'ciUpperLimit': '1.47', 'groupDescription': 'Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.', 'description': 'Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.', 'unitOfMeasure': 'ratio', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).'}, {'type': 'SECONDARY', 'title': 'Ratio of Interleukin-1 Beta (IL-1β) in Serum at End of Treatment Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD5069', 'description': 'AZD5069 80 mg bd'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for AZD5069, bd'}], 'classes': [{'categories': [{'measurements': [{'value': '1.45', 'groupId': 'OG000', 'lowerLimit': '1.25', 'upperLimit': '1.67'}, {'value': '0.93', 'groupId': 'OG001', 'lowerLimit': '0.80', 'upperLimit': '1.07'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.56', 'ciLowerLimit': '1.28', 'ciUpperLimit': '1.91', 'groupDescription': 'Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.', 'description': 'Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.', 'unitOfMeasure': 'ratio', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).'}, {'type': 'SECONDARY', 'title': 'Ratio of Interleukin-8 (IL-8) in Serum at End of Treatment Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD5069', 'description': 'AZD5069 80 mg bd'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo for AZD5069, bd'}], 'classes': [{'categories': [{'measurements': [{'value': '5.90', 'groupId': 'OG000', 'lowerLimit': '4.74', 'upperLimit': '7.34'}, {'value': '0.97', 'groupId': 'OG001', 'lowerLimit': '0.78', 'upperLimit': '1.21'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '6.07', 'ciLowerLimit': '4.42', 'ciUpperLimit': '8.35', 'groupDescription': 'Analysis of covariance included treatment, inhaled corticosteroids, Pseudomonas aeruginosa infection and baseline as covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.', 'description': 'Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.', 'unitOfMeasure': 'ratio', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PD analysis set comprised all patients who received at least 1 dose of study medication and for whom PD samples (absolute and percentage neutrophil cell count in sputum, sputum collection weight, inflammatory markers in sputum and serum) were available (assumed not to be affected by factors such as protocol violations).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AZD5069', 'description': 'AZD5069 80 mg bd'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo for AZD5069, bd'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This multicenter study was conducted in Europe between 27 December 2010 and 13 February 2012.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'AZD5069', 'description': 'AZD5069 80 mg bd'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo bd'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66', 'spread': '6.6', 'groupId': 'BG000'}, {'value': '65', 'spread': '8.8', 'groupId': 'BG001'}, {'value': '65', 'spread': '7.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-07', 'studyFirstSubmitDate': '2010-12-02', 'resultsFirstSubmitDate': '2015-06-25', 'studyFirstSubmitQcDate': '2010-12-06', 'lastUpdatePostDateStruct': {'date': '2015-10-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-09-07', 'studyFirstPostDateStruct': {'date': '2010-12-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ratio of Absolute Neutrophil Cell Count in Sputum at End of Treatment Compared to Baseline', 'timeFrame': 'End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.', 'description': 'Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.'}], 'secondaryOutcomes': [{'measure': 'Ratio of the Percentage Neutrophil Cell Count in Sputum at End of Treatment Compared to Baseline', 'timeFrame': 'End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.', 'description': 'Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.'}, {'measure': 'Change From Baseline in Weight of 24-hour Sputum Collection', 'timeFrame': 'Baseline and end of treatment (Day 28)', 'description': 'Patients collected all sputum produced during a 24-hour period at baseline and Day 28.'}, {'measure': 'Change From Baseline in Slow Vital Capacity (SVC)', 'timeFrame': 'Baseline to end of treatment (Day 28)', 'description': 'Lung function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. SVC is the measure of the change in volume of gas in the lungs from complete inspiration to complete expiration.'}, {'measure': 'Change From Baseline in Forced Vital Capacity (FVC)', 'timeFrame': 'Baseline to end of treatment (Day 28)', 'description': 'Lung function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FVC is the maximum volume of air which can be exhaled or inspired during a forced maneuver.'}, {'measure': 'Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)', 'timeFrame': 'Baseline to end of treatment (Day 28)', 'description': 'Lung function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FEV1 is the volume expired in the first second of maximal expiration after a full inspiration.'}, {'measure': 'Change From Baseline in Forced Expiratory Flow Between 25% and 75% of Forced Vital Capacity (FEF25-75)', 'timeFrame': 'Baseline to end of treatment (Day 28)', 'description': 'Lung function tests consisted of 3 forced expiratory maneuvers in which the patient expired forcefully from total lung capacity to residual volume, recorded using a spirometer. FEF25-75 is flow rate during the middle half of forced vital capacity (25%-75% of the total volume (FVC) exhaled).'}, {'measure': 'Transition Dyspnea Index (TDI) at End of Treatment (Day 28)', 'timeFrame': 'Baseline to end of treatment (Day 28)', 'description': 'TDI measures changes in dyspnea severity from the baseline as established by the Baseline Dyspnea Index (BDI). TDI is an interviewer-administered rating of severity of dyspnea that assesses Change in Functional Impairment, Change in Magnitude of Task, and Change in Magnitude of Effort domains on a 7-point scale ranging from -3 (major deterioration) to +3 (major improvement). Total score ranges from -9 to +9. The lower the score, the more deterioration in severity of dyspnea.'}, {'measure': 'Change From Baseline for the Morning PEF and Evening PEF of the Bronkotest Diary Card', 'timeFrame': 'Baseline and Last 7 days on treatment', 'description': 'The Bronkotest diary card is a paper based diary card that was filled out by patients daily, recording values from morning and evening peak expiratory flow (PEF) measurements and answering 8 questions on signs and symptoms. Summary statistics for baseline (mean of the last 7 days prior to first dose) and change (mean of the last 7 days on treatment - baseline) only contain patients included in the analysis. For symptom scores a decrease is an improvement, for PEF an increase is an improvement.'}, {'measure': 'Change From Baseline for the Symptom Scores of the Bronkotest Diary Card', 'timeFrame': 'Baseline and Last 7 days on treatment', 'description': 'The Bronkotest diary card is a paper based diary card that was filled out by patients daily, recording values from morning and evening peak expiratory flow (PEF) measurements and answering 8 questions on signs and symptoms. Symptom scores were recorded for night-time symptoms, breathing, sputum colour, sputum amount, sputum type, wellbeing, number of puffs of inhalers, and cough, generally scored on a scale from 0 (no symptoms) to 4 (worst symptoms). Summary statistics for baseline (mean of the last 7 days prior to first dose) and change (mean of the last 7 days on treatment - baseline) only contain patients included in the analysis. For symptom scores a decrease is an improvement, for PEF an increase is an improvement.'}, {'measure': "Change From Baseline Total and Domain Scores in St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C)", 'timeFrame': 'Baseline and end of treatment (Day 28)', 'description': "SGRQ-C total score shows the impact of COPD on patient's health status, and expressed as a percentage of impairment with scale from 0 (best health status) to 100 (worst possible status). The SGRQ-C contains 3 domains:\n\nSymptom (distress due to respiratory symptoms), Activity (disturbance of physical activity) and Impact (overall impact on daily life and well being). All three domains with scale from 0 (best health status) to 100 (worst possible status)."}, {'measure': 'Ratio of Interleukin-1 Beta (IL-1β) in Sputum at End of Treatment Compared to Baseline', 'timeFrame': 'End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.', 'description': 'Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.'}, {'measure': 'Ratio of Interleukin-6 (IL-6) in Sputum at End of Treatment Compared to Baseline', 'timeFrame': 'End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.', 'description': 'Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.'}, {'measure': 'Ratio of Regulated on Activation, Normal T Cell Expressed and Secreted (RANTES) in Sputum at End of Treatment Compared to Baseline', 'timeFrame': 'End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.', 'description': 'Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.'}, {'measure': 'Ratio of Monocyte Chemoattractant Protein-1 (MCP-1) in Sputum at End of Treatment Compared to Baseline', 'timeFrame': 'End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.', 'description': 'Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.'}, {'measure': 'Ratio of Tumor Necrosis Factor Alpha (TNF-α) in Sputum at End of Treatment Compared to Baseline', 'timeFrame': 'End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.', 'description': 'Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.'}, {'measure': 'Ratio of Growth-related Oncogene-α (GRO-α) in Sputum at End of Treatment Compared to Baseline', 'timeFrame': 'End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.', 'description': 'Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.'}, {'measure': 'Ratio of Interleukin-8 (IL-8) in Sputum at End of Treatment Compared to Baseline', 'timeFrame': 'End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.', 'description': 'Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.'}, {'measure': 'Ratio of Neutrophil Elastase Activity in Sputum at End of Treatment Compared to Baseline', 'timeFrame': 'End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.', 'description': 'Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.'}, {'measure': 'Ratio of Serum Amyloid A (SAA) in Serum at End of Treatment Compared to Baseline', 'timeFrame': 'End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.', 'description': 'Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.'}, {'measure': 'Ratio of C-reactive Protein (CRP) in Serum at End of Treatment Compared to Baseline', 'timeFrame': 'End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.', 'description': 'Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.'}, {'measure': 'Ratio of Tumor Necrosis Factor Alpha (TNF-α) in Serum at End of Treatment Compared to Baseline', 'timeFrame': 'End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.', 'description': 'Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.'}, {'measure': 'Ratio of Growth-related Oncogene-α (GRO-α) in Serum at End of Treatment Compared to Baseline', 'timeFrame': 'End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.', 'description': 'Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.'}, {'measure': 'Ratio of Interleukin-6 (IL-6) in Serum at End of Treatment Compared to Baseline', 'timeFrame': 'End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.', 'description': 'Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.'}, {'measure': 'Ratio of Interleukin-1 Beta (IL-1β) in Serum at End of Treatment Compared to Baseline', 'timeFrame': 'End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.', 'description': 'Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.'}, {'measure': 'Ratio of Interleukin-8 (IL-8) in Serum at End of Treatment Compared to Baseline', 'timeFrame': 'End of treatment values from 3 visits (day 21 to 28) and baseline values from 3 visits.', 'description': 'Ratio of the mean of 3 visits at the end of the treatment period to the mean of the 3 baseline visits.'}]}, 'conditionsModule': {'keywords': ['Bronchiectasis', 'Neutrophil', 'Respiratory disease', 'Sputum'], 'conditions': ['Bronchiectasis', 'Lung Disease', 'Respiratory Diseases']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=209&filename=D3550C00014_Study_Synopsis.pdf', 'label': 'CSR Synopsis'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effect of AZD5069 in patients with bronchiectasis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male, or female of non-child bearing potential; ie, women who are permanently or surgically sterilised or post-menopausal.\n* Aged 18 to 80 years inclusive at screening (Visit 1)\n* Have a clinical diagnosis of idiopathic or post infective bronchiectasis as diagnosed with a historical high resolution computerised tomography (HRCT) or bronchogram\n* Be sputum producers with a history of chronic expectoration on most days of most weeks of the year. Patients should have a history of spontaneously producing sputum on a daily basis and should be able to provide at least 2 of the 3 required baseline sputum samples with an average of 3 mL or more.\n* Be on a stable treatment regimen, as judged by the investigator.\n\nExclusion Criteria:\n\n* Any clinically significant disease or disorder\n* Patients with other latent or chronic infections or at risk of infection within 90 days before Visit 2\n* An acute exacerbation or acute respiratory infection (upper or lower) requiring oral steroids or antibiotics within 30 days prior to Visit 2\n* An FEV1 of \\<30% of predicted normal at Visit 1\n* Patients who have received live or live-attenuated vaccine in the 2 weeks prior to dosing (Visit 2)\n* Concomitant diagnosis of significant pulmonary disease other than bronchiectasis or COPD, including symptomatic asthma and allergic bronchopulmonary aspergillosis\n* Bronchiectasis associated with a generalised immunodeficiency disorder, where manifestations other than bronchiectasis predominate'}, 'identificationModule': {'nctId': 'NCT01255592', 'acronym': 'STRATUS', 'briefTitle': 'Evaluation of the Effect of AZD5069 in Patients With Bronchiectasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase II Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28-Day Oral Administration of AZD5069 Twice Daily in Patients With Bronchiectasis', 'orgStudyIdInfo': {'id': 'D3550C00014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Treatment arm AZD5069', 'interventionNames': ['Drug: AZD5069']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo dose.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AZD5069', 'type': 'DRUG', 'description': 'Oral dose bid', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral dose bid', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ostrava', 'country': 'Czechia', 'facility': 'Research Site', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Research Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Krakow', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Lodz', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': 'Research Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Hull', 'state': 'East Yorkshire', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}, {'city': 'Leicester', 'state': 'Leicestershire', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'city': 'Birmingham', 'state': 'Wstmid', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'city': 'Belfast', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}, {'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'city': 'Salford', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 53.48771, 'lon': -2.29042}}, {'city': 'Wolverhampton', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 52.58547, 'lon': -2.12296}}], 'overallOfficials': [{'name': 'Bengt Larsson,, M.B', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca R&D Mölndal'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}