Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-02-21 @ 4:09 AM
Study NCT ID:
NCT02694393
Status:
TERMINATED
Last Update Posted:
2024-06-24
First Post:
2016-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Inhaled Sodium Nitrite as an Antimicrobial for Cystic Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012977', 'term': 'Sodium Nitrite'}], 'ancestors': [{'id': 'D009573', 'term': 'Nitrites'}, {'id': 'D009608', 'term': 'Nitrous Acid'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pilewskijm@upmc.edu', 'phone': '(412) 692-2210\u202c', 'title': 'Dr. Joseph Pilewski', 'organization': 'University of Pittsburgh'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The study was terminated early due to expiration of investigational product and lack of a manufacturer.'}}, 'adverseEventsModule': {'timeFrame': 'Up to 42 days following first drug administration visit', 'description': 'The adverse events predicted to be of interest were: methemoglobinemia, hypotension and bronchoconstriction (as measured by FEV1)', 'eventGroups': [{'id': 'EG000', 'title': 'Nebulized Nitrite', 'description': '40-80 mg nebulized nitrite administration', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Methemoglobinemia', 'notes': 'Increase in methemoglobin level measured noninvasively', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'notes': 'Asymptomatic hypotension in the setting of phlebotomy, resolved without intervention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased FEV1', 'notes': 'FEV1 decrease of \\<15% at second', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pulmonary Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebulized Nitrite', 'description': 'Nebulized sodium nitrite, 40-80 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000', 'lowerLimit': '37', 'upperLimit': '81'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 7', 'description': 'forced expiratory volume in one second (FEV1) after inhalation will assess safety', 'unitOfMeasure': 'percentage of predicted FEV1', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pulmonary Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebulized Nitrite', 'description': 'Nebulized sodium nitrite, 40-80 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28', 'description': 'forced expiratory volume in one second (FEV1) after inhalation will assess safety', 'unitOfMeasure': 'percentage of predicted FEV1', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Exhaled Nitric Oxide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebulized Nitrite', 'description': 'Nebulized sodium nitrite, 40-80 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '12'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 7', 'description': 'concentration of nitric oxide in exhaled breath', 'unitOfMeasure': 'parts per billion', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Exhaled Nitric Oxide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebulized Nitrite', 'description': 'Nebulized sodium nitrite, 40-80 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28', 'description': 'concentration of nitric oxide in exhaled breath', 'unitOfMeasure': 'parts per billion', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sputum Nitrite Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebulized Nitrite', 'description': 'Nebulized sodium nitrite, 40-80 mg'}], 'timeFrame': 'day 7', 'description': 'concentration of nitrite in sputum', 'reportingStatus': 'POSTED', 'populationDescription': 'Sputum nitrite data not collected/measured'}, {'type': 'SECONDARY', 'title': 'Sputum Nitrite Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebulized Nitrite', 'description': 'Nebulized sodium nitrite, 40-80 mg'}], 'timeFrame': 'day 28', 'description': 'concentration of nitrite in sputum', 'reportingStatus': 'POSTED', 'populationDescription': 'Sputum nitrite data not collected/measured'}, {'type': 'SECONDARY', 'title': 'Pseudomonas Density in Sputum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebulized Nitrite', 'description': 'Nebulized sodium nitrite, 40-80 mg'}], 'timeFrame': 'day 28', 'description': 'density of Pseudomonas in sputum', 'reportingStatus': 'POSTED', 'populationDescription': 'Pseudomonas density in sputum data not collected/measured'}, {'type': 'SECONDARY', 'title': 'CF Questionnaire - Respiratory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nebulized Nitrite', 'description': 'Nebulized sodium nitrite, 40-80 mg'}], 'timeFrame': 'day 28', 'description': 'respiratory symptom questionnaire', 'reportingStatus': 'POSTED', 'populationDescription': 'respiratory symptom questionnaire data not collected/measured'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nebulized Nitrite', 'description': 'Nebulized nitrite, 40-80 mg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'The study had a 2 week wash-out period during which inhaled antibiotics were held before the drug was dosed. If participants had a drop in percent predicted FEV1 between the screening visit and Visit 1 where the drug was dosed, they were excluded from the study. Of our 4 enrolled subjects, 1 subject withdrew from study participation during the washout period and 1 subject failed the wash-out period and was excluded from the study before being assigned to treatment arm.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Sodium Nitrite', 'description': 'Inhalation of 46 or 80 mg of sodium nitrite twice daily for four weeks\n\nsodium nitrite: inhalation of 46 or 80 mg of sodium nitrite by electronic nebulization'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25.5', 'groupId': 'BG000', 'lowerLimit': '20', 'upperLimit': '31'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'FEV1 (Percent predicted)', 'classes': [{'categories': [{'measurements': [{'value': '61.5', 'groupId': 'BG000', 'lowerLimit': '48', 'upperLimit': '75'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percent predicted FEV1', 'dispersionType': 'FULL_RANGE'}, {'title': 'exhaled Nitric Oxide', 'classes': [{'categories': [{'measurements': [{'value': '6.5', 'groupId': 'BG000', 'lowerLimit': '5', 'upperLimit': '8'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Parts per billion', 'dispersionType': 'FULL_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-28', 'size': 621052, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-05-29T08:07', 'hasProtocol': True}, {'date': '2016-02-18', 'size': 333442, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-07-21T18:35', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'Protocol closed due to difficulty recruiting subjects and then expiration of investigational product and lack of a manufacturer.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2022-07-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-18', 'studyFirstSubmitDate': '2016-01-11', 'resultsFirstSubmitDate': '2023-07-21', 'studyFirstSubmitQcDate': '2016-02-23', 'lastUpdatePostDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-06-18', 'studyFirstPostDateStruct': {'date': '2016-02-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulmonary Function', 'timeFrame': 'Day 7', 'description': 'forced expiratory volume in one second (FEV1) after inhalation will assess safety'}, {'measure': 'Pulmonary Function', 'timeFrame': 'Day 28', 'description': 'forced expiratory volume in one second (FEV1) after inhalation will assess safety'}], 'secondaryOutcomes': [{'measure': 'Exhaled Nitric Oxide', 'timeFrame': 'Day 7', 'description': 'concentration of nitric oxide in exhaled breath'}, {'measure': 'Exhaled Nitric Oxide', 'timeFrame': 'Day 28', 'description': 'concentration of nitric oxide in exhaled breath'}, {'measure': 'Sputum Nitrite Concentration', 'timeFrame': 'day 7', 'description': 'concentration of nitrite in sputum'}, {'measure': 'Sputum Nitrite Concentration', 'timeFrame': 'day 28', 'description': 'concentration of nitrite in sputum'}, {'measure': 'Pseudomonas Density in Sputum', 'timeFrame': 'day 28', 'description': 'density of Pseudomonas in sputum'}, {'measure': 'CF Questionnaire - Respiratory', 'timeFrame': 'day 28', 'description': 'respiratory symptom questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cystic Fibrosis']}, 'referencesModule': {'references': [{'pmid': '20696868', 'type': 'BACKGROUND', 'citation': 'Major TA, Panmanee W, Mortensen JE, Gray LD, Hoglen N, Hassett DJ. Sodium nitrite-mediated killing of the major cystic fibrosis pathogens Pseudomonas aeruginosa, Staphylococcus aureus, and Burkholderia cepacia under anaerobic planktonic and biofilm conditions. Antimicrob Agents Chemother. 2010 Nov;54(11):4671-7. doi: 10.1128/AAC.00379-10. Epub 2010 Aug 9.'}, {'pmid': '25229185', 'type': 'BACKGROUND', 'citation': 'Zemke AC, Shiva S, Burns JL, Moskowitz SM, Pilewski JM, Gladwin MT, Bomberger JM. Nitrite modulates bacterial antibiotic susceptibility and biofilm formation in association with airway epithelial cells. Free Radic Biol Med. 2014 Dec;77:307-16. doi: 10.1016/j.freeradbiomed.2014.08.011. Epub 2014 Sep 16.'}]}, 'descriptionModule': {'briefSummary': 'This study will assess the safety of inhaled sodium nitrite in adults with Cystic Fibrosis and chronic Pseudomonas infections, and determine the ability of sodium nitrite to reduce the burden of Pseudomonas.', 'detailedDescription': 'Pseudomonas aeruginosa infects the airways of 80% of adults with Cystic Fibrosis (CF). In these patients, P. aeruginosa forms extremely antibiotic resistant biofilm communities that accelerate progression of obstructive lung disease. Current treatment of airway infection focuses on monthly cycles of inhaled antibiotics. However up to 20% of adults are infected with multi drug resistant P. aeruginosa for which we have no effective inhaled treatments. These isolates are more common as patients age so with the increasing life expectancy of the CF population, MDR P. aeruginosa is likely to remain a clinical problem. Another 10% of patients are infected with other Gram-negative organisms such as Burkholderia cepacia and Achromobacter species, for which we have inadequate suppressive treatment. Following lung transplant, MDR airway infections remain a problem as the allografts are colonized by strains carried in the paranasal sinuses. Sodium nitrite may present a new antimicrobial approach to treating respiratory infection with Gram-negative organisms, because it is able to prevent biotic biofilm formation.\n\nWithin the CF lung, P. aeruginosa grows as a biotic biofilm in association with airway epithelial cells and mucous plaques. This environment has an acidic pH and low oxygen tension with many bacteria subsisting through denitrification (both conditions where traditional antibiotics are less effective). Because biotic biofilms can be up to 500-fold more resistant than biofilms grown on abiotic surfaces, with support from our CF Research Development Program (RDP) Cores, we showed that nitrite prevents biofilm formation on the surface of primary CF airway epithelial cells. Moreover, nitrite dose-dependently potentiates the effects of colistin sulfate in liquid culture, and in biotic biofilms on airway epithelial cells. These data support the hypothesis that nebulized sodium nitrite will inhibit growth of Pseudomonas aeruginosa in CF airways, and identify a potential therapeutic benefit for nitrite alone and cooperatively with colistin as a novel therapy to inhibit P. aeruginosa in CF airways. Nebulized nitrite has been through extensive animal toxicology, and is well tolerated by subjects with pulmonary arterial hypertension where it is being studied as a pulmonary vasodilator.\n\nTo determine the therapeutic potential of sodium nitrite for CF, we propose two specific aims:\n\nAim 1: Determine the safety of nebulized sodium nitrite administered in two doses to patients with CF.\n\nAim 2: Explore the effects of inhaled sodium nitrite on measures of lung function, exhaled airway nitric oxide, and bacterial burden as measured by quantitative sputum cultures.\n\nTo accomplish these aims, we propose a Phase I/II open-label study of sodium nitrite in CF. Key inclusion criteria include individuals over the age 18 with cystic fibrosis as documented by clinical features of CF, and genotyping or a positive sweat test. Exclusion criteria include advanced lung disease, inability to discontinue inhaled antibiotics for four weeks, hospitalization or medication change within 4 weeks of enrollment, baseline systemic hypotension (SBP\\<90 mm hg), chronic kidney disease (Cr \\>2.5), severe anemia (Hgb \\<9 gm/dL in the last six months). The primary outcome is safety, defined as FEV1 measured before and after initial doses on days 0 and 7, and at week 4. Other safety data for the initial doses include pulse oximetry and transcutaneous methemoglobin levels. Secondary endpoints include quantitative sputum cultures, exhaled nitric oxide, sputum nitrite concentration, and patient symptoms as assessed by a CF specific respiratory questionnaire.\n\nCompletion of this study will guide the development of sodium nitrite as a single agent for CF infections, and inform future studies examining the effects of sodium nitrite in combination with inhaled colistin for patients with drug resistant bacterial pathogens that are an increasing problem. In addition, the study will provide important safety and efficacy data that may inform future development of inhaled sodium nitrite as a therapy in young patients to augment airway host defense and prevent biofilm formation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cystic Fibrosis as documented by clinical features, and documentation of a positive sweat test or two disease causing mutation of the CF gene.\n\nExclusion Criteria:\n\n* use of supplemental oxygen, FEV1 \\< 40% predicted, inability to discontinue inhaled antibiotics for 4 weeks,\n* hospitalization within 4 weeks prior to enrollment,\n* change in maintenance CF therapies within 4 weeks of enrollment,\n* severe anemia, significant chronic liver disease, severe pulmonary hypertension, prior organ transplantation'}, 'identificationModule': {'nctId': 'NCT02694393', 'briefTitle': 'Inhaled Sodium Nitrite as an Antimicrobial for Cystic Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Phase I/II Study of Inhaled Sodium Nitrite as an Antimicrobial for Pseudomonas Infection in Cystic Fibrosis', 'orgStudyIdInfo': {'id': 'PRO15040062'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'sodium nitrite', 'description': 'Inhalation of 46 or 80 mg of sodium nitrite twice daily for four weeks', 'interventionNames': ['Drug: sodium nitrite']}], 'interventions': [{'name': 'sodium nitrite', 'type': 'DRUG', 'otherNames': ['AIR001'], 'description': 'inhalation of 46 or 80 mg of sodium nitrite by electronic nebulization', 'armGroupLabels': ['sodium nitrite']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Pittsburgh", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Comprehensive Lung Center - Falk Clinic', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Joseph Pilewski, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Schmidhofer, Mark, MD', 'class': 'INDIV'}, 'collaborators': [{'name': 'Mast Therapeutics, Inc.', 'class': 'INDUSTRY'}, {'name': 'Cystic Fibrosis Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine and Pediatrics', 'investigatorFullName': 'Joseph Pilewski', 'investigatorAffiliation': 'University of Pittsburgh'}}}}