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

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ClinicalTrials.gov Identifier: NCT04685720
Recruitment Status : Recruiting
First Posted : December 28, 2020
Last Update Posted : December 28, 2020
Sponsor:
Information provided by (Responsible Party):
Beyond Air Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Non-Tuberculous Mycobacterial Pneumonia Cystic Fibrosis Mycobacterial Pneumonia Mycobacterium Abscessus Infection Mycobacterium Avium Complex Device: LungFit Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 7, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Inhaled NO delivered using LungFit
Inhaled Nitric Oxide in doses up to 250 ppm
 Device: LungFit
LungFit for NTM is an experimental device that produces Nitric Oxide from the ambient air.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Changes in NTM bacterial load from baseline to Day 174 [ Time Frame: Day 1 to Day 174 ]
    Changes in NTM bacterial load will be assessed by sputum culture in liquid and solid media.

  2. Number of patients with culture conversion at Day 174 [ Time Frame: Day 1 to Day 174 ]
    NTM culture conversion will be defined as having at least three consecutive negative NTM cultures

  3. Changes in quality of life assessed by CFQ-R for or QOL-B with NTM module [ Time Frame: Day 1 to Day 174 ]
    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.

  4. Changes in FEV1 from baseline to Day 174 [ Time Frame: Day 1 to Day 174 ]
    Respiratory function will be assessed by spirometry including FEV1.

  5. Changes in activity tracker data as assessed by changes in distance from baseline to Day 174. [ Time Frame: Day 1 to Day 174 ]
    Patients will collect activity tracker data from 2 weeks before treatment and from Day 1 to Day 174.

  6. Change in 6 Minute Walking Test [ Time Frame: Day 1 to Day 84 ]
    Change in 6 Minute Walking Test will be assessed by changes in distance between baseline and Day 84


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04685720


Contacts
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Contact: Vladislava Zamfirova 4102364368 vzamfirova@beyondair.net
Contact: Enoch Bortey 9198891214 ebortey@beyondair.net

Locations
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Australia, Queensland
Gallipoli Medical Research Foundation Recruiting
Greenslopes, Queensland, Australia, 4120
Contact: Rachel Thomson, MD       r.thomson@uq.edu.au   
Principal Investigator: Rachel Thomson, MD         
Sponsors and Collaborators
Beyond Air Inc.
More Information
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Responsible Party: Beyond Air Inc.
ClinicalTrials.gov Identifier: NCT04685720    
Other Study ID Numbers: BA_NTM_AU_01.01
First Posted: December 28, 2020    Key Record Dates
Last Update Posted: December 28, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Pneumonia
Mycobacterium Infections
Mycobacterium avium-intracellulare Infection
Mycobacterium Infections, Nontuberculous
Cystic Fibrosis
Fibrosis
Disease Attributes
Pathologic Processes
Respiratory Tract Infections
 Lung Diseases
Respiratory Tract Diseases
Pancreatic Diseases
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses