Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2026-02-20 @ 6:46 PM
Study NCT ID:
NCT01815866
Status:
COMPLETED
Last Update Posted:
2015-10-14
First Post:
2013-03-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cough-Generated Aerosols of NTM in Cystic Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Sputum cultures'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-13', 'studyFirstSubmitDate': '2013-03-19', 'studyFirstSubmitQcDate': '2013-03-19', 'lastUpdatePostDateStruct': {'date': '2015-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of CF patients who produce culturable aerosols of NTM during coughing.', 'timeFrame': '6 weeks', 'description': 'Patients with CF and a positive sputum or bronchoalveolar lavage (BAL) culture for NTM will cough into a chamber filled with culture plates that can measure droplet size. The investigators are looking for large droplets, that could land on surfaces and be a source for infection transmission, as well as fine droplets(5 microns or less)that are consistent with airborne transmission.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Positive Nontuberculous Mycobacteria'], 'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': 'Non-tuberculous mycobacteria (NTM) are opportunistic pathogens normally found in soil and water that are being cultured from Cystic Fibrosis (CF) airways at an increasing frequency. They have been demonstrated to cause clinically significant lung disease in some cases and the transmission of NTM, from person to person has been proposed. There are currently no standardized guidelines for isolation of those colonized or infected with NTM.\n\nThe investigators will measure particle droplet size from patients with CF who have positive sputum cultures for NTM with the hypothesis that they will be in a range that can spread infection.', 'detailedDescription': 'Patients with a positive NTM sputum culture will be asked to participate in the study. If they agree to participate they will sign an informed consent and will be scheduled to come to the University of Florida Clinical Research Center for the testing.\n\nThe test will consist of the following: pulmonary function test, collecting a sputum culture if possible, coughing for 5 minutes into a tube connected to a canister, hypertonic saline and albuterol will be given after the 5 minutes of coughing and then they would repeat with another 5 minutes of coughing. There can be a break inbetween the coughing if needed.\n\nPatients maybe asked to come back a second time if they develop a different type of NTM or start treatment for NTM.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '8 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Specialialty Clinics, Pulmonary', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age greater than or equal to age 8 years\n* Confirmed Diagnosis of CF\n* Sputum/Throat/Bronchoscopic culture positive for NTM within the last 12 months\n\nExclusion Criteria:\n\n* Pregnancy\n* Pneumothorax within the last 6 months\n* Forced Expiratory Volume at one second \\<30% predicted\n* Hemoptysis greater than 1 tablespoon within the last 7 days'}, 'identificationModule': {'nctId': 'NCT01815866', 'briefTitle': 'Cough-Generated Aerosols of NTM in Cystic Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Cough-Generated Aerosols of Nontuberculous Mycobacteria in Patients With Cystic Fibrosis', 'orgStudyIdInfo': {'id': '484-2012'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CF with culturable NTM', 'description': 'CF patients who produce culturable aerosols of NTM will receive the following test: pulmonary function test, collecting a sputum culture if possible, coughing for 5 minutes into a tube connected to a canister, hypertonic saline and albuterol will be given after the 5 minutes of coughing and then they would repeat with another 5 minutes of coughing. There can be a break inbetween the coughing if needed.', 'interventionNames': ['Procedure: CF with culturable NTM']}], 'interventions': [{'name': 'CF with culturable NTM', 'type': 'PROCEDURE', 'description': 'CF patients who produce culturable aerosols of NTM will receive the following test: pulmonary function test, collecting a sputum culture if possible, coughing for 5 minutes into a tube connected to a canister, hypertonic saline and albuterol will be given after the 5 minutes of coughing and then they would repeat with another 5 minutes of coughing. There can be a break inbetween the coughing if needed.', 'armGroupLabels': ['CF with culturable NTM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida Clinical Research Center', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Pamela M Schuler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'collaborators': [{'name': "Children's Miracle Network", 'class': 'OTHER'}, {'name': 'UF Peds', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}