Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2025-12-26 @ 2:49 AM
Study NCT ID:
NCT01455402
Status:
COMPLETED
Last Update Posted:
2014-07-09
First Post:
2011-10-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Observational Study to Assess RSV-associated Illness in Adults With COPD and/or CHF
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D006333', 'term': 'Heart Failure'}], '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': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum, whole blood, plasma, nasal swab, sputum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 476}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-08', 'studyFirstSubmitDate': '2011-10-12', 'studyFirstSubmitQcDate': '2011-10-19', 'lastUpdatePostDateStruct': {'date': '2014-07-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence rate of inpatient RSV-associated acute respiratory illness or events leading to worsening cardiorespiratory status', 'timeFrame': 'Average of 2 years'}], 'secondaryOutcomes': [{'measure': 'All-cause inpatient acute respiratory illnesses or events leading to worsening cardiorespiratory status', 'timeFrame': 'Average of 2 years'}, {'measure': 'Mortality through all RSV seasons of follow up for RSV-associated deaths and all-cause deaths', 'timeFrame': 'Average of 2 years'}, {'measure': 'Healthcare utilization for RSV-associated and all-cause medically attended acute respiratory illnesses or events leading to worsening cardiorespiratory status', 'timeFrame': 'Average of 2 years'}, {'measure': 'Incidence of RSV-associated secondary bacterial pneumonia events', 'timeFrame': 'Average of 2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Respiratory Syncytial Virus, Chronic Obstructive Pulmonary Disease, Congestive Heart Failure, Observational'], 'conditions': ['Respiratory Syncytial Virus, Chronic Obstructive Pulmonary Disease, Congestive Heart Failure']}, 'descriptionModule': {'briefSummary': 'The primary objective of this observational study is to determine the incidence of medically attended (inpatient or outpatient) acute respiratory illnesses or events leading to worsening cardiorespiratory status (ie, acute exacerbations of chronic obstructive pulmonary disease \\[AECOPD\\] or worsening CHF) associated with RSV infections in high-risk adults (ie, those with severe COPD and/or advanced CHF) across multiple consecutive RSV seasons.', 'detailedDescription': 'It is expected that this observational study will provide further understanding of the clinical impact and true incidence rates of RSV-associated hospitalizations and medically attended acute respiratory illnesses or events leading to worsening cardiorespiratory status in adults with COPD and/or CHF who are at increased risk for serious sequelae associated with RSV infections. As part of the evaluation, this study will collect symptom and physiologic data, and blood, nasal swab, and sputum in order to investigate the relationship of RSV infections with clinical endpoints.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of adults with severe COPD and/or CHF who expect to have contact with children. Potential subjects will be identified through the medical record and extended invitations to volunteer.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Age 50 years or greater\n* Hospitalization due to worsening COPD and/or CHF\n* Severe COPD subjects (Global Initiative for Obstructive Lung Disease Stage III/IV); FEV1 \\<50%\n* Chronic CHF subjects (New York Heart Association Class III/IV or American College of Cardiology-American Heart Association Stage C/D); Ejection fraction \\< 40%\n* Expects to have direct contact with children at least once a month\n\nKey Exclusion Criteria:\n\n\\- Participation in another clinical study involving the use of investigational product'}, 'identificationModule': {'nctId': 'NCT01455402', 'acronym': 'CD-1089', 'briefTitle': 'An Observational Study to Assess RSV-associated Illness in Adults With COPD and/or CHF', 'organization': {'class': 'INDUSTRY', 'fullName': 'MedImmune LLC'}, 'officialTitle': 'An Observational Study to Assess Respiratory Syncytial Virus (RSV)-Associated Illness in Adults With Chronic Obstructive Pulmonary Disease (COPD) and/or Congestive Heart Failure (CHF)', 'orgStudyIdInfo': {'id': 'CD-ID-MEDI-557-1089'}, 'secondaryIdInfos': [{'id': 'D3150L00001', 'type': 'OTHER', 'domain': 'AstraZeneca AB'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '72901', 'city': 'Fort Smith', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.38592, 'lon': -94.39855}}, {'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'Bay Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 27.81419, 'lon': -82.77816}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '51503', 'city': 'Council Bluffs', 'state': 'Iowa', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.26194, 'lon': -95.86083}}, {'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '89502', 'city': 'Reno', 'state': 'Nevada', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}, {'zip': '14215-1199', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '11501', 'city': 'Mineola', 'state': 'New York', 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