Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2025-12-27 @ 10:43 PM
Study NCT ID:
NCT01375361
Status:
WITHDRAWN
Last Update Posted:
2013-10-10
First Post:
2010-04-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nebulized Albuterol for Congestive Heart Failure Exacerbation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000420', 'term': 'Albuterol'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Low enrollment.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'lastUpdateSubmitDate': '2013-10-09', 'studyFirstSubmitDate': '2010-04-20', 'studyFirstSubmitQcDate': '2011-06-16', 'lastUpdatePostDateStruct': {'date': '2013-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Borg Dyspnea Score', 'timeFrame': '8 hours.', 'description': 'Patients are evaluated for approximatly 8 hours with the Borg Dyspnea Score. Starting at the time of arrival, then one hour later and consequently every two hours until reaching 8 hours in total.\n\nThe Borg score is used to quantify the degree of shortness of breath a person is experiencing which is a measured on a 10 point visual-analog scale.'}], 'secondaryOutcomes': [{'measure': 'Admission', 'timeFrame': 'An average of 48 hours', 'description': 'If the patient is hospitalized we will continue to record information about their hospital stay and the patient will not receive more study interventions.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['albuterol'], 'conditions': ['Congestive Heart Failure']}, 'descriptionModule': {'briefSummary': 'This is a randomized trial of the use of Albuterol in the setting of acute decompensated Congestive Heart Failure with radiographic evidence of Cardiogenic Pulmonary Edema.', 'detailedDescription': 'The objective is to carry out a randomized blinded placebo-controlled trial of inhaled Albuterol as an early therapy for patients with decompensated Congestive Heart Failure. Compared to placebo, inhaled Albuterol will improve oxygenation and decrease the need for non-invasive ventilation in patients with Cardiogenic Pulmonary Edema.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18-65 with shortness of breath and history of CHF\n* pulmonary edema on chest xr\n\nExclusion Criteria:\n\n* pregnancy\n* clinical or ekg changes to suggest acute coronary syndrome\n* history of copd or asthma\n* history of albuterol on medication list'}, 'identificationModule': {'nctId': 'NCT01375361', 'acronym': 'ACHE', 'briefTitle': 'Nebulized Albuterol for Congestive Heart Failure Exacerbation', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'orgStudyIdInfo': {'id': 'RandomizedAlbuterolCHF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Inhaled Albuterol', 'description': "Patients identified to have Cardiogenic Pulmonary Edema, will receive 2.5mg of Albuterol nebulizer on enrollment in the study and again at 4 hours. Patients will be monitored on telemetry in the emergency department during and after study drug administration. Although study drug administration will cease after 4 hours, we will continue to record ongoing data during the patient's hospitalization.", 'interventionNames': ['Drug: Albuterol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Inhaled Placebo.', 'description': 'Patients identified to have Cardiogenic Pulmonary Edema will receive 2.5mg Normal saline inhaled (Placebo) on enrollment and at 4 hours in the emergency department. Patient will be monitor on telemetry in the emergency department during and after placebo administration.', 'interventionNames': ['Drug: Normal Saline']}], 'interventions': [{'name': 'Albuterol', 'type': 'DRUG', 'otherNames': ['Administration of Albuterol.'], 'description': '2.5mg Albuterol inhaled on enrollment and at 4 hours in the emergency department.', 'armGroupLabels': ['Inhaled Albuterol']}, {'name': 'Normal Saline', 'type': 'DRUG', 'otherNames': ['Administration of Placebo.'], 'description': '2.5mg Normal Saline inhaled on enrollment and at 4 hours in emergency department.', 'armGroupLabels': ['Inhaled Placebo.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'John C. Stein, MD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}