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

NCT ID: NCT04685720

Last Updated: 2022-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-07
• Study Completion Date: 2022-10-10

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-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.

Conditions

Non-Tuberculous Mycobacterial Pneumonia; Cystic Fibrosis; Mycobacterial Pneumonia; Mycobacterium Abscessus Infection; Mycobacterium Avium Complex

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Inhaled NO delivered using LungFit

Inhaled Nitric Oxide in doses up to 250 ppm

Group Type: EXPERIMENTAL

LungFit

Intervention Type: DEVICE

LungFit for NTM is an experimental device that produces Nitric Oxide from the ambient air.

Interventions

LungFit

LungFit for NTM is an experimental device that produces Nitric Oxide from the ambient air.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beyond Air Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Gallipoli Medical Research Foundation

Greenslopes, Queensland, Australia

Countries

Australia

Other Identifiers

BA_NTM_AU_01.01

Identifier Type: -

Identifier Source: org_study_id