Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-03-07 @ 2:49 PM
Study NCT ID:
NCT02416102
Status:
TERMINATED
Last Update Posted:
2020-08-20
First Post:
2015-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Losartan on Airway Mucociliary Dysfunction in Patients With COPD and Chronic Bronchitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D029481', 'term': 'Bronchitis, Chronic'}], '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': 'D001991', 'term': 'Bronchitis'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019808', 'term': 'Losartan'}], 'ancestors': [{'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013777', 'term': 'Tetrazoles'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'msalathe@kumc.edu', 'phone': '913-588-6000', 'title': 'Matthias Salathe, MD', 'organization': 'University of Miami'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '8 Weeks', 'description': 'Only treatment-emergent Adverse Events will be reported as per treating physician discretion.', 'eventGroups': [{'id': 'EG000', 'title': 'Healthy Non-smokers', 'description': '10 healthy non-smokers will receive 50 mg of losartan for 4 weeks followed by 100 mg of losartan for 4 weeks\n\nLosartan 50 mg: 50 mg QD for 4 weeks\n\nlosartan 100 mg: 50 mg BID for 4 weeks', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Smokers Without COPD', 'description': '10 smokers without COPD will receive 50 mg of losartan for 4 weeks followed by 100 mg of losartan for 4 weeks\n\nLosartan 50 mg: 50 mg QD for 4 weeks\n\nlosartan 100 mg: 50 mg BID for 4 weeks', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Ex-smokers With COPD', 'description': '10 ex-smokers with COPD will receive 50 mg of losartan for 4 weeks followed by 100 mg of losartan for 4 weeks\n\nLosartan 50 mg: 50 mg QD for 4 weeks\n\nlosartan 100 mg: 50 mg BID for 4 weeks', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Nasal Potential Difference (NPD).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Non-smokers', 'description': '10 healthy non-smokers will receive 50 mg of losartan for 4 weeks followed by 100 mg of losartan for 4 weeks\n\nLosartan 50 mg: 50 mg QD for 4 weeks\n\nlosartan 100 mg: 50 mg BID for 4 weeks'}, {'id': 'OG001', 'title': 'Smokers Without COPD', 'description': '10 smokers without COPD will receive 50 mg of losartan for 4 weeks followed by 100 mg of losartan for 4 weeks\n\nLosartan 50 mg: 50 mg QD for 4 weeks\n\nlosartan 100 mg: 50 mg BID for 4 weeks'}, {'id': 'OG002', 'title': 'Ex-smokers With COPD', 'description': '10 ex-smokers with COPD will receive 50 mg of losartan for 4 weeks followed by 100 mg of losartan for 4 weeks\n\nLosartan 50 mg: 50 mg QD for 4 weeks\n\nlosartan 100 mg: 50 mg BID for 4 weeks'}], 'timeFrame': 'Baseline, 8 weeks', 'description': 'NPD were assessed from nasal cells collected using sterile cytology brushes.', 'reportingStatus': 'POSTED', 'populationDescription': 'Nasal sample data for all participants were not available as the readings were uninterpretable and not further analyzed.'}, {'type': 'SECONDARY', 'title': 'Change in IL-8 Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Non-smokers', 'description': '10 healthy non-smokers will receive 50 mg of losartan for 4 weeks followed by 100 mg of losartan for 4 weeks\n\nLosartan 50 mg: 50 mg QD for 4 weeks\n\nlosartan 100 mg: 50 mg BID for 4 weeks'}, {'id': 'OG001', 'title': 'Smokers Without COPD', 'description': '10 smokers without COPD will receive 50 mg of losartan for 4 weeks followed by 100 mg of losartan for 4 weeks\n\nLosartan 50 mg: 50 mg QD for 4 weeks\n\nlosartan 100 mg: 50 mg BID for 4 weeks'}, {'id': 'OG002', 'title': 'Ex-smokers With COPD', 'description': '10 ex-smokers with COPD will receive 50 mg of losartan for 4 weeks followed by 100 mg of losartan for 4 weeks\n\nLosartan 50 mg: 50 mg QD for 4 weeks\n\nlosartan 100 mg: 50 mg BID for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '2867', 'spread': '1685', 'groupId': 'OG000'}, {'value': '4676', 'spread': '1948', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Interleukin (IL)-8 concentrations were analyzed from samples on nasal lavage', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'No participants were recruited in the Ex-Smokers with COPD due to difficulty in recruitment prior to study termination. Only 5 participants were analyzed for the Healthy Non-Smokers and Smokers without COPD arms as only 5 in each group had complete sets of samples that could be analyzed due to bad quality/quantity available.'}, {'type': 'SECONDARY', 'title': 'Percent Change in TGF-ß mRNA Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Non-smokers', 'description': '10 healthy non-smokers will receive 50 mg of losartan for 4 weeks followed by 100 mg of losartan for 4 weeks\n\nLosartan 50 mg: 50 mg QD for 4 weeks\n\nlosartan 100 mg: 50 mg BID for 4 weeks'}, {'id': 'OG001', 'title': 'Smokers Without COPD', 'description': '10 smokers without COPD will receive 50 mg of losartan for 4 weeks followed by 100 mg of losartan for 4 weeks\n\nLosartan 50 mg: 50 mg QD for 4 weeks\n\nlosartan 100 mg: 50 mg BID for 4 weeks'}, {'id': 'OG002', 'title': 'Ex-smokers With COPD', 'description': '10 ex-smokers with COPD will receive 50 mg of losartan for 4 weeks followed by 100 mg of losartan for 4 weeks\n\nLosartan 50 mg: 50 mg QD for 4 weeks\n\nlosartan 100 mg: 50 mg BID for 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-51', 'spread': '31', 'groupId': 'OG000'}, {'value': '-23', 'spread': '70', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Transforming Growth Factor (TGF)-ß messenger ribonucleic acid (mRNA) expression were analyzed from nasal cells samples.', 'unitOfMeasure': 'percentage change in mRNA expression', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'No participants were recruited in the Ex-Smokers with COPD due to difficulty in recruitment prior to study termination. Only 5 participants were analyzed for the Healthy Non-Smokers and Smokers without COPD arms as only 5 in each group had complete sets of samples that could be analyzed due to bad quality/quantity available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Healthy Non-smokers', 'description': '10 healthy non-smokers will receive 50 mg of losartan for 4 weeks followed by 100 mg of losartan for 4 weeks\n\nLosartan 50 mg: 50 mg once daily (QD) for 4 weeks\n\nlosartan 100 mg: 50 mg twice daily (BID) for 4 weeks'}, {'id': 'FG001', 'title': 'Smokers Without COPD', 'description': '10 smokers without Chronic Obstructive Pulmonary Disease (COPD) will receive 50 mg of losartan for 4 weeks followed by 100 mg of losartan for 4 weeks\n\nLosartan 50 mg: 50 mg QD for 4 weeks\n\nlosartan 100 mg: 50 mg BID for 4 weeks'}, {'id': 'FG002', 'title': 'Ex-smokers With COPD', 'description': '10 ex-smokers with COPD will receive 50 mg of losartan for 4 weeks followed by 100 mg of losartan for 4 weeks\n\nLosartan 50 mg: 50 mg QD for 4 weeks\n\nlosartan 100 mg: 50 mg BID for 4 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Healthy Non-smokers', 'description': '10 healthy non-smokers will receive 50 mg of losartan for 4 weeks followed by 100 mg of losartan for 4 weeks\n\nLosartan 50 mg: 50 mg QD for 4 weeks\n\nlosartan 100 mg: 50 mg BID for 4 weeks'}, {'id': 'BG001', 'title': 'Smokers Without COPD', 'description': '10 smokers without COPD will receive 50 mg of losartan for 4 weeks followed by 100 mg of losartan for 4 weeks\n\nLosartan 50 mg: 50 mg QD for 4 weeks\n\nlosartan 100 mg: 50 mg BID for 4 weeks'}, {'id': 'BG002', 'title': 'Ex-smokers With COPD', 'description': '10 ex-smokers with COPD will receive 50 mg of losartan for 4 weeks followed by 100 mg of losartan for 4 weeks\n\nLosartan 50 mg: 50 mg QD for 4 weeks\n\nlosartan 100 mg: 50 mg BID for 4 weeks'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'There was a difficulty in recruitment ex-smokers with COPD prior to study termination'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-02-01', 'size': 506270, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-07-20T12:44', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'whyStopped': 'Difficulty in recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'dispFirstSubmitDate': '2019-06-26', 'completionDateStruct': {'date': '2017-04-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-07', 'studyFirstSubmitDate': '2015-01-16', 'dispFirstSubmitQcDate': '2019-08-01', 'resultsFirstSubmitDate': '2020-08-07', 'studyFirstSubmitQcDate': '2015-04-08', 'dispFirstPostDateStruct': {'date': '2019-08-12', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-08-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-07', 'studyFirstPostDateStruct': {'date': '2015-04-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Nasal Potential Difference (NPD).', 'timeFrame': 'Baseline, 8 weeks', 'description': 'NPD were assessed from nasal cells collected using sterile cytology brushes.'}], 'secondaryOutcomes': [{'measure': 'Change in IL-8 Concentrations', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Interleukin (IL)-8 concentrations were analyzed from samples on nasal lavage'}, {'measure': 'Percent Change in TGF-ß mRNA Expression', 'timeFrame': 'Baseline, 8 weeks', 'description': 'Transforming Growth Factor (TGF)-ß messenger ribonucleic acid (mRNA) expression were analyzed from nasal cells samples.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COPD', 'Chronic Bronchitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of Losartan on cigarette smoke-induced lung injury in smokers and ex-smokers with and without chronic obstructive pulmonary disease (COPD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Fulfill one of the group definitions above\n2. Age between 35 and 75 years old\n3. Clinical diagnosis of chronic bronchitis, defined as productive cough for at least 3 months per year for at least two consecutive years\n4. Stable maintenance of all current medication therapy for 3 months, including ARBs for treated groups\n\nExclusion criteria\n\n1. Current therapy with Angiotensin-converting-enzyme (ACE) inhibitor,or Intolerance to Angiotensin II receptor blockers (ARB)\n2. Women of child bearing potential\n3. Current use of nonsteroidal antiinflammatory drugs or potassium supplementation, treatment with aliskiren, anticoagulation\n4. COPD exacerbation requiring treatment within 6 weeks of the screening visit\n5. Oral corticosteroid use within 6 weeks of the screening visit\n6. Significant hypoxemia (oxygen saturation \\<90% on room air), chronic respiratory failure by history (pCO2 \\> 45 mmHg) and forced expiratory volume in 1 second (FEV1) below 40%, clinical evidence of cor pulmonale\n7. Untreated arterial hypertension (systolic blood pressure \\>140 mm Hg, diastolic blood pressure \\> 90 mm Hg)\n8. Ability to understand and willingness to sign consent documents\n9. Blood pressure less than 100 mm Hg systolic or 70 mm Hg diastolic while standing at the screening visit\n10. Cardiac, renal, hepatic (LFTs \\> 3x normal upper limit), neurological, psychiatric, endocrine or neoplastic diseases that are at the discretion of the investigator, to interfere with participation in study\n11. History of renal artery stenosis\n12. Concomitant airway disorders other than COPD and chronic bronchitis, such as bronchiectasis and asthma (history and reversible airflow obstruction by American Thoracic Society (ATS) criteria)\n13. History of pulmonary malignancies, and any other malignancies in the last 5 years\n14. History of thoracic surgery.\n15. Acute pulmonary exacerbation within 6 weeks from the Screening Visit.\n16. Subjects with no airflow obstruction by spirometry but with a decrease in diffusing capacity of lung for carbon monoxide(DLco) possibly indicating emphysema.\n17. Significant exposure to environmental tobacco smoke or atmospheric or occupational pollutants\n18. Urine pregnancy positive test at the Screening Visit.'}, 'identificationModule': {'nctId': 'NCT02416102', 'briefTitle': 'Effect of Losartan on Airway Mucociliary Dysfunction in Patients With COPD and Chronic Bronchitis', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Effect of Losartan on Airway Mucociliary Dysfunction in Patients With COPD and Chronic Bronchitis', 'orgStudyIdInfo': {'id': '20140722'}, 'secondaryIdInfos': [{'id': 'R01HL133240', 'link': 'https://reporter.nih.gov/quickSearch/R01HL133240', 'type': 'NIH'}, {'id': 'R01HL139365', 'link': 'https://reporter.nih.gov/quickSearch/R01HL139365', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy non-smokers', 'description': '10 healthy non-smokers will receive 50 mg of Losartan for 4 consecutive weeks followed by 100 mg of Losartan for 4 consecutive weeks.', 'interventionNames': ['Drug: Losartan 50 mg', 'Drug: Losartan 100 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Smokers without COPD', 'description': '10 smokers without COPD will receive 50 mg of Losartan for 4 consecutive weeks followed by 100 mg of Losartan for 4 consecutive weeks.', 'interventionNames': ['Drug: Losartan 50 mg', 'Drug: Losartan 100 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Ex-smokers with COPD', 'description': '10 ex-smokers with COPD will receive 50 mg of Losartan for 4 consecutive weeks followed by 100 mg of Losartan for 4 consecutive weeks.', 'interventionNames': ['Drug: Losartan 50 mg', 'Drug: Losartan 100 mg']}], 'interventions': [{'name': 'Losartan 50 mg', 'type': 'DRUG', 'otherNames': ['Cozaar'], 'description': '50 mg Losartan taken orally once daily for 4 consecutive weeks.', 'armGroupLabels': ['Ex-smokers with COPD', 'Healthy non-smokers', 'Smokers without COPD']}, {'name': 'Losartan 100 mg', 'type': 'DRUG', 'otherNames': ['Cozaar'], 'description': '50 mg Losartan taken orally twice daily for 4 consecutive weeks.', 'armGroupLabels': ['Ex-smokers with COPD', 'Healthy non-smokers', 'Smokers without COPD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Rafael Calderon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': 'Flight Attendant Medical Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Rafael Calderon Candelario', 'investigatorAffiliation': 'University of Miami'}}}}