A Pilot Study to Assess the Effect of Intermittent iNO on the Treatment of NTM Lung Infection in CF and Non-CF Patients

Beyond Air

Status

Completed

Conditions

Non-Tuberculous Mycobacterial Pneumonia

Mycobacterium Abscessus Infection

Mycobacterial Pneumonia

Cystic Fibrosis

Mycobacterium Avium Complex

Treatments

Device: LungFit

Study type

Interventional

Funder types

Industry

Identifiers

NCT04685720

BA_NTM_AU_01.01

Details and patient eligibility

About

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.

Full 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-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.

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects diagnosed with refractory NTM (MAC or MAbs) pulmonary infection
CF and Non-CF patients

Exclusion criteria

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