Status:
COMPLETED
A Pilot Study to Assess the Effect of Intermittent iNO on the Treatment of NTM Lung Infection in CF and Non-CF Patients
Lead Sponsor:
Beyond Air Inc.
Conditions:
Non-Tuberculous Mycobacterial Pneumonia
Cystic Fibrosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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.
Detailed Description
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-...
Eligibility Criteria
Inclusion
- Subjects diagnosed with refractory NTM (MAC or MAbs) pulmonary infection
- CF and Non-CF patients
Exclusion
- Diagnosis of methemoglobinemia or MetHb ≥2% at screening; treatment with any drug known to increase MetHb; known or suspected hemoglobinopathy.
- History of or current myeloproliferative disease, leukemia or other hematological malignancy; known or suspected immunodeficiency disease.
- Subjects with advanced cardiovascular disease or CHF
- Use of an investigational drug during the 30 days prior to enrollment.
- History of frequent epistaxis (\>1 episode/month); significant hemoptysis (during the 30 days prior to enrollment.
- 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.
- Active pulmonary malignancy (primary or metastatic) or any malignancy; history of lung transplantation.
- Pulmonary tuberculosis requiring treatment or treated within 2 years prior to screening.
- Uncontrolled hypertension within 3 months prior to or at screening
- Diagnosis of significant pulmonary hypertension indicated on echocardiogram at screening
- Clinically significant renal or liver laboratory abnormalities
- History of daily, continuous oxygen supplementation.
- Women of childbearing potential - pregnant or breastfeeding, or not on medically acceptable double methods of contraception from enrollment until Day 84.
- Smoking tobacco or any substance within 6 months prior to screening or anticipated inability to refrain from smoking throughout the study.
- Patient receiving drugs that have a contraindication with NO
Key Trial Info
Start Date :
December 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2022
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04685720
Start Date
December 7 2020
End Date
October 10 2022
Last Update
December 16 2022
Active Locations (1)
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1
Gallipoli Medical Research Foundation
Greenslopes, Queensland, Australia, 4120