Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT04685720
Status:
COMPLETED
Last Update Posted:
2022-12-16
First Post:
2020-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Pilot Study to Assess the Effect of Intermittent iNO on the Treatment of NTM Lung Infection in CF and Non-CF Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}, {'id': 'D009165', 'term': 'Mycobacterium Infections, Nontuberculous'}, {'id': 'D015270', 'term': 'Mycobacterium avium-intracellulare Infection'}], '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'}, {'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-14', 'studyFirstSubmitDate': '2020-12-07', 'studyFirstSubmitQcDate': '2020-12-24', 'lastUpdatePostDateStruct': {'date': '2022-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment-Emergent SAEs', 'timeFrame': 'Day 1 to Day 84', 'description': 'The primary endpoint of the study is the number of patients with treatment-emergent SAEs'}], 'secondaryOutcomes': [{'measure': 'Changes in NTM bacterial load from baseline to Day 174', 'timeFrame': 'Day 1 to Day 174', 'description': 'Changes in NTM bacterial load will be assessed by sputum culture in liquid and solid media.'}, {'measure': 'Number of patients with culture conversion at Day 174', 'timeFrame': 'Day 1 to Day 174', 'description': 'NTM culture conversion will be defined as having at least three consecutive negative NTM cultures'}, {'measure': 'Changes in quality of life assessed by CFQ-R for or QOL-B with NTM module', 'timeFrame': 'Day 1 to Day 174', 'description': 'Changes in quality of life assessed by Cystic Fibrosis Questionnaire Revised \\[CFQ R\\] for CF patients or Quality of Life Questionnaire-Bronchiectasis \\[QOL-B\\] with NTM module for non-CF patients.'}, {'measure': 'Changes in FEV1 from baseline to Day 174', 'timeFrame': 'Day 1 to Day 174', 'description': 'Respiratory function will be assessed by spirometry including FEV1.'}, {'measure': 'Changes in activity tracker data as assessed by changes in distance from baseline to Day 174.', 'timeFrame': 'Day 1 to Day 174', 'description': 'Patients will collect activity tracker data from 2 weeks before treatment and from Day 1 to Day 174.'}, {'measure': 'Change in 6 Minute Walking Test', 'timeFrame': 'Day 1 to Day 84', 'description': 'Change in 6 Minute Walking Test will be assessed by changes in distance between baseline and Day 84'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-Tuberculous Mycobacterial Pneumonia', 'Cystic Fibrosis', 'Mycobacterial Pneumonia', 'Mycobacterium Abscessus Infection', 'Mycobacterium Avium Complex']}, 'descriptionModule': {'briefSummary': 'The purpose of this open-label, multicenter, non-randomized, pilot study is to assess the safety of high dose intermittent iNO for treatment of NTM infection in CF and non-CF patients.', 'detailedDescription': 'The study will include 20 patients from up to four clinical sites in Australia. The overall treatment plan includes 2 weeks of inhalation treatments (intensive phase) of iNO four times per day at 4.5-hour intervals followed by 10 weeks of inhalation treatments (maintenance phase) at the maximum tolerated dose (a maximum of 250 ppm NO) inhaled twice daily.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects diagnosed with refractory NTM (MAC or MAbs) pulmonary infection\n* CF and Non-CF patients\n\nExclusion Criteria:\n\n* Diagnosis of methemoglobinemia or MetHb ≥2% at screening; treatment with any drug known to increase MetHb; known or suspected hemoglobinopathy.\n* History of or current myeloproliferative disease, leukemia or other hematological malignancy; known or suspected immunodeficiency disease.\n* Subjects with advanced cardiovascular disease or CHF\n* Use of an investigational drug during the 30 days prior to enrollment.\n* History of frequent epistaxis (\\>1 episode/month); significant hemoptysis (during the 30 days prior to enrollment.\n* Subject on non-constant dose of systemic steroids within 30 days prior to enrollment; subjects on constant systemic steroids if the daily dose is higher than 10 mg/d prednisolone or equivalent.\n* Active pulmonary malignancy (primary or metastatic) or any malignancy; history of lung transplantation.\n* Pulmonary tuberculosis requiring treatment or treated within 2 years prior to screening.\n* Uncontrolled hypertension within 3 months prior to or at screening\n* Diagnosis of significant pulmonary hypertension indicated on echocardiogram at screening\n* Clinically significant renal or liver laboratory abnormalities\n* History of daily, continuous oxygen supplementation.\n* Women of childbearing potential - pregnant or breastfeeding, or not on medically acceptable double methods of contraception from enrollment until Day 84.\n* Smoking tobacco or any substance within 6 months prior to screening or anticipated inability to refrain from smoking throughout the study.\n* Patient receiving drugs that have a contraindication with NO'}, 'identificationModule': {'nctId': 'NCT04685720', 'briefTitle': 'A Pilot Study to Assess the Effect of Intermittent iNO on the Treatment of NTM Lung Infection in CF and Non-CF Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Beyond Air Inc.'}, 'officialTitle': 'A Pilot Study to Assess the Effect of Intermittent Inhaled Nitric Oxide on the Treatment of Nontuberculous Mycobacteria (NTM) Lung Infection in Cystic Fibrosis and Non-Cystic Fibrosis Patients', 'orgStudyIdInfo': {'id': 'BA_NTM_AU_01.01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Inhaled NO delivered using LungFit', 'description': 'Inhaled Nitric Oxide in doses up to 250 ppm', 'interventionNames': ['Device: LungFit']}], 'interventions': [{'name': 'LungFit', 'type': 'DEVICE', 'description': 'LungFit for NTM is an experimental device that produces Nitric Oxide from the ambient air.', 'armGroupLabels': ['Inhaled NO delivered using LungFit']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4120', 'city': 'Greenslopes', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Gallipoli Medical Research Foundation', 'geoPoint': {'lat': -27.50815, 'lon': 153.04951}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beyond Air Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}