Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT00500318
Status:
COMPLETED
Last Update Posted:
2017-01-06
First Post:
2007-07-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of Exercise Endurance and Lung Hyperinflation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}, {'id': 'D004646', 'term': 'Emphysema'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C542859', 'term': 'aclidinium bromide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'information.center@astrazeneca.com', 'phone': '1-877-240-9479', 'title': 'AstraZeneca Clinical', 'organization': 'Study Information Center'}, 'certainAgreement': {'otherDetails': 'All data generated in this study will be the property of the Sponsor. An integrated clinical and statistical report will be prepared at the completion of the study.\n\nPublication of the results by the Investigator will be subject to mutual agreement between the Investigator and the Sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected from July of 2007 to December of 2008 at 52 study sites (42 sites in the United States and 10 additional sites in Canada)', 'eventGroups': [{'id': 'EG000', 'title': 'Aclidinium', 'description': 'Aclidinium bromide, 200 micrograms, oral inhalation once per day.', 'otherNumAtRisk': 86, 'otherNumAffected': 16, 'seriousNumAtRisk': 86, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Dose-matched placebo, oral inhalation, once per day.', 'otherNumAtRisk': 95, 'otherNumAffected': 18, 'seriousNumAtRisk': 95, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Chronic Obstructive Pulmonary Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}], 'seriousEvents': [{'term': 'Ileitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Diverticulum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Bladder transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Exercise Endurance Time (ET)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aclidinium', 'description': 'Aclidinium bromide, 200 micrograms, oral inhalation once per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Dose-matched placebo, oral inhalation, once per day.'}], 'classes': [{'categories': [{'measurements': [{'value': '129.45', 'spread': '31.19', 'groupId': 'OG000'}, {'value': '13.01', 'spread': '30.97', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0042', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '116.44', 'ciLowerLimit': '37.280', 'ciUpperLimit': '195.610', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '40.113', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From baseline Week 0 (Visit 4) to Week 6 (Visit 6)', 'description': 'Exercise endurance time is defined as the time from the increase in work rate at 75% Wmax (watts) to the point of symptom limitation. The Wmax is defined as the highest work rate the patients were able to maintain for at least 30 seconds.', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Missing data for patients who withdrew due to COPD exacerbations was imputed using the Worst Observation Carried Forward (WOCF) of all Endurance time (ET), while ETs that were missing for other reasons were imputed using the Last Observation Carried Forward (LOCF) method based on the last visit available.'}, {'type': 'SECONDARY', 'title': 'Trough Forced Expiratory Volume in 1 Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aclidinium', 'description': 'Aclidinium bromide, 200 micrograms, oral inhalation once per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Dose-matched placebo, oral inhalation, once per day.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.090', 'spread': '0.018', 'groupId': 'OG000'}, {'value': '-0.010', 'spread': '0.018', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from baseline (Visit 4) at Week 6 (Visit 6)', 'description': 'Change in trough Forced Expiratory Volume in 1 second. FEV1 was assessed at the end of the daily dosing interval (Trough).', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-Treat (ITT) population consisted of all patients in the Safety Population who had at least a baseline and one post-baseline assessment of the primary efficacy parameter. Missing values due to a premature discontinuation or patients who missed specific trial visits were imputed by Last Observation Carried Forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Trough Inspiratory Capacity (IC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aclidinium', 'description': 'Aclidinium bromide, 200 micrograms, oral inhalation once per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Dose-matched placebo, oral inhalation, once per day.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.083', 'spread': '0.032', 'groupId': 'OG000'}, {'value': '-0.019', 'spread': '0.032', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6)', 'description': 'Change in trough Inspiratory Capacity. Inspiratory Capacity was measured as part of the spirometry procedures performed at each visit. IC was assessed at the end of the daily dosing interval (Trough).', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-Treat (ITT) population consisted of all patients in the Safety Population who had at least a baseline and one post-baseline assessment of the primary efficacy parameter. Missing values due to a premature discontinuation or patients who missed specific trial visits were imputed by Last Observation Carried Forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Functional Residual Capacity (FRC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aclidinium', 'description': 'Aclidinium bromide, 200 micrograms, oral inhalation once per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Dose-matched placebo, oral inhalation, once per day.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.138', 'spread': '0.061', 'groupId': 'OG000'}, {'value': '-0.076', 'spread': '0.064', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6)', 'description': 'Change in trough Functional Residual Capacity. FRC was assessed at the end of the daily dosing interval (Trough).', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-Treat (ITT) population consisted of all patients in the Safety Population who had at least a baseline and one post-baseline assessment of the primary efficacy parameter. Missing values due to a premature discontinuation or patients who missed specific trial visits were imputed by Last Observation Carried Forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Inspiratory Capacity (IC)/Total Lung Capacity (TLC) Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aclidinium', 'description': 'Aclidinium bromide, 200 micrograms, oral inhalation once per day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Dose-matched placebo, oral inhalation, once per day.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.014', 'spread': '0.006', 'groupId': 'OG000'}, {'value': '-0.003', 'spread': '0.006', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6)', 'description': 'Ratio of trough Inspiratory Capacity verses Total Lung Capacity.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-Treat (ITT) population consisted of all patients in the Safety Population who had at least a baseline and one post-baseline assessment of the primary efficacy parameter. Missing values due to a premature discontinuation or patients who missed specific trial visits were imputed by Last Observation Carried Forward (LOCF).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aclidinium', 'description': 'Aclidinium bromide, 200 micrograms, oral inhalation once per day.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Dose-matched placebo, oral inhalation, once per day.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '95'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '78'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Other Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Patient recruitment occurred from July to October of 2007 at 52 study sites (42 sites in the United States and 10 additional sites in Canada)', 'preAssignmentDetails': 'All demographic and baseline characteristics were analyzed descriptively just for the Safety population.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '181', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Aclidinium', 'description': 'Aclidinium bromide, 200 micrograms, oral inhalation once per day.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Dose-matched placebo, oral inhalation, once per day.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.0', 'spread': '9.5', 'groupId': 'BG000'}, {'value': '65.6', 'spread': '7.8', 'groupId': 'BG001'}, {'value': '64.8', 'spread': '8.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 181}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'dispFirstSubmitDate': '2011-09-09', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-16', 'studyFirstSubmitDate': '2007-07-10', 'dispFirstSubmitQcDate': '2011-09-09', 'resultsFirstSubmitDate': '2012-08-14', 'studyFirstSubmitQcDate': '2007-07-10', 'dispFirstPostDateStruct': {'date': '2011-09-21', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-01-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-11-16', 'studyFirstPostDateStruct': {'date': '2007-07-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Exercise Endurance Time (ET)', 'timeFrame': 'From baseline Week 0 (Visit 4) to Week 6 (Visit 6)', 'description': 'Exercise endurance time is defined as the time from the increase in work rate at 75% Wmax (watts) to the point of symptom limitation. The Wmax is defined as the highest work rate the patients were able to maintain for at least 30 seconds.'}], 'secondaryOutcomes': [{'measure': 'Trough Forced Expiratory Volume in 1 Second (FEV1)', 'timeFrame': 'Change from baseline (Visit 4) at Week 6 (Visit 6)', 'description': 'Change in trough Forced Expiratory Volume in 1 second. FEV1 was assessed at the end of the daily dosing interval (Trough).'}, {'measure': 'Trough Inspiratory Capacity (IC)', 'timeFrame': 'Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6)', 'description': 'Change in trough Inspiratory Capacity. Inspiratory Capacity was measured as part of the spirometry procedures performed at each visit. IC was assessed at the end of the daily dosing interval (Trough).'}, {'measure': 'Functional Residual Capacity (FRC)', 'timeFrame': 'Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6)', 'description': 'Change in trough Functional Residual Capacity. FRC was assessed at the end of the daily dosing interval (Trough).'}, {'measure': 'Inspiratory Capacity (IC)/Total Lung Capacity (TLC) Ratio', 'timeFrame': 'Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6)', 'description': 'Ratio of trough Inspiratory Capacity verses Total Lung Capacity.'}]}, 'conditionsModule': {'keywords': ['Bronchitis, Chronic; Emphysema'], 'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'referencesModule': {'references': [{'pmid': '21183326', 'type': 'DERIVED', 'citation': 'Maltais F, Celli B, Casaburi R, Porszasz J, Jarreta D, Seoane B, Caracta C. Aclidinium bromide improves exercise endurance and lung hyperinflation in patients with moderate to severe COPD. Respir Med. 2011 Apr;105(4):580-7. doi: 10.1016/j.rmed.2010.11.019. Epub 2010 Dec 22.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluated the effect of inhaled aclidinium bromide on exercise endurance and in reducing resting and dynamic lung hyperinflation in patients with moderate to severe COPD. It was 9 weeks in duration, consisting of; a 2-week run-in period, 6 weeks of double-blind treatment, and a 1-week follow-up phone call. All patients meeting the eligibility criteria were randomized to one of two treatment groups: aclidinium bromide or placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A diagnosis of stable moderate to severe COPD (GOLD 2006); post-levalbuterol FEV1 \\>=30% and \\< 80% predicted and FEV1/FVC\\<70% predicted\n* Current or former cigarette smoker\n* Functional Residual Capacity (FRC) measured by body plethysmography \\>= 120% of predicted value\n* Baseline Dyspnea Index (BDI) focal score ≤ 7 at Visit 4\n\nExclusion Criteria:\n\n* History of presence of asthma, allergic rhinitis, or atopy\n* Hospitalization for acute COPD exacerbation in the 3 months prior to study entry\n* Respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks prior to study entry\n* Clinically significant respiratory conditions other than COPD\n* Chronic use of oxygen therapy \\>= 15 hours a day'}, 'identificationModule': {'nctId': 'NCT00500318', 'briefTitle': 'A Study of Exercise Endurance and Lung Hyperinflation in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 6-Week Clinical Study to Assess the Effect of Inhaled Aclidinium Bromide (LAS34273) 200 ug on Exercise Endurance and Lung Hyperinflation in Patients With Moderate to Severe COPD', 'orgStudyIdInfo': {'id': 'LAS-MD-CL26'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aclidinium', 'interventionNames': ['Drug: Aclidinium Bromide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Aclidinium Bromide', 'type': 'DRUG', 'description': 'Aclidinium Bromide, 200μg. Once daily oral inhalation.', 'armGroupLabels': ['Aclidinium']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Dose matched placebo, once daily oral inhalation.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35501', 'city': 'Jasper', 'state': 'Alabama', 'country': 'United States', 'facility': 'Forest Investigative Site 2088', 'geoPoint': {'lat': 33.83122, 'lon': -87.27751}}, {'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Forest Investigative Site 0909', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90822', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 0957', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90073', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 0973', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095-1690', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 0887', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 0988', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Forest Investigative Site 0885', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '33756', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 2663', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Forest Investigative Site 1030', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32504', 'city': 'Pensacola', 'state': 'Florida', 'country': 'United 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{'zip': '66606', 'city': 'Topeka', 'state': 'Kansas', 'country': 'United States', 'facility': 'Forest Investigative Site 1080', 'geoPoint': {'lat': 39.04833, 'lon': -95.67804}}, {'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Forest Investigative Site 0898', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02135', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Forest Investigative Site 0886', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02747', 'city': 'North Dartmouth', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Forest Investigative Site 1029', 'geoPoint': {'lat': 41.63899, 'lon': -70.97032}}, {'zip': '48152', 'city': 'Livonia', 'state': 'Michigan', 'country': 'United States', 'facility': 'Forest Investigative Site 0889', 'geoPoint': {'lat': 42.36837, 'lon': -83.35271}}, {'zip': '63301', 'city': 'Saint Charles', 'state': 'Missouri', 'country': 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