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

Beyond Air Inc.1 site in 1 country15 target enrollmentDecember 7, 2020

ConditionsNon-Tuberculous Mycobacterial Pneumonia Cystic Fibrosis Mycobacterial Pneumonia Mycobacterium Abscessus Infection Mycobacterium Avium Complex

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Non-Tuberculous Mycobacterial Pneumonia
Sponsor: Beyond Air Inc.
Enrollment: 15
Locations: 1
Primary Endpoint: Treatment-Emergent SAEs
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 7, 2020

End Date

October 10, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Beyond Air Inc.

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Treatment-Emergent SAEs

Time Frame: Day 1 to Day 84

The primary endpoint of the study is the number of patients with treatment-emergent SAEs

Secondary Outcomes

Changes in NTM bacterial load from baseline to Day 174(Day 1 to Day 174)
Changes in FEV1 from baseline to Day 174(Day 1 to Day 174)
Change in 6 Minute Walking Test(Day 1 to Day 84)
Number of patients with culture conversion at Day 174(Day 1 to Day 174)
Changes in quality of life assessed by CFQ-R for or QOL-B with NTM module(Day 1 to Day 174)
Changes in activity tracker data as assessed by changes in distance from baseline to Day 174.(Day 1 to Day 174)