Pilot Study to Test Nitric Oxide Gas Treatment on Nontuberculous Mycobacteria Infections

Pilot Study to Test Nitric Oxide Gas Treatment on Nontuberculous Mycobacteria Infections

A small, pilot Phase 1/2 clinical trial evaluating the safety and efficacy of Thiolanox inhaled nitric oxide gas in treating nontuberculous mycobacteria (NTM) infection has been approved by Health Canada.

Patients with non-cystic fibrosis bronchiectasis, chronic obstructive pulmonary disease, and other chronic lung illnesses are at particularly high risk of contracting NTM infections. These are commonly caused by inhalation of Mycobacterium avium complex (MAC), Mycobacterium kansasii, and Mycobacterium abscessus complex (MABSC) opportunistic microorganisms.

Difficult to eradicate, these bacteria can require long-term antibiotic therapy, which can promote the development of multi-drug resistant bacteria strains. Alternative treatments that can tackle NTM infections are, for this reason, of high interest.

Nitric oxide is a small molecule that is naturally produced by the body, and takes part in several important biological mechanisms, including body defense. The use of external nitric oxide has been shown to work as an effective antimicrobial agent, and to be safe and well-tolerated in clinical trials.

Use of nitric oxide at low concentrations is approved in Canada to treat pulmonary hypertension in newborns.

Thiolanox is a nitric oxide gas formulation developed by Novoteris that is administrated using the company’s computerized trace-gas delivery system. Based on a mixture of 0.5% of nitric oxide with 99.5% of medical grade nitrogen, it is designed to promote antibacterial mechanisms directly in the lungs upon inhalation.

The pilot clinical trial (NCT03331445) will evaluate the safety of Thiolanox, primarily, but also its efficacy in treating NTM infection in adults. Led by Jeremy D. Road, MD, professor at University of British Columbia, the study will enroll 10 people diagnosed with MAC or MABSC infection.

“The clearances by Health Canada will enable us to expand our work with this novel therapy to a wider range of people with an exceptional need for more effective antimicrobials,” Alex Stenzler, president of Novoteris, said in a press release.

The primary objective of the study is to determine any safety issues related to nitric oxide inhalation in a NTM-infected population. The investigators will also evaluate the impact of the treatment on patient’s lung function, measured as change from baseline on forced expiratory volume, and its capacity to eliminate the bacteria.

The trial is currently recruiting patients at its Vancouver site. For more information, please click on this link.


  1. Carolyn J. Smith says:

    I have bronchiectasis. However, if I swallow any antibiotic, the ulcerative colitis kicks in.
    I have been lucky to have one doctor give me shots–but no one else will.
    The treatment for ulcerative colitis is destroying my hearing.
    I am 80 (but look and act younger if I am not running a temp.)
    Should I just plan to shoot myself when it gets bad?

    • Susanne says:

      Drs. Gave me IV antibiotic through a port. Contact National Jewish Health, Denver, Colorado
      This is what they specialize in.

  2. Andrea Smith says:

    Dear Carolyn,
    No, you shouldn’t shoot yourself. You can try different antibiotics, fewer antibiotics (often people take three — you could take one or two, as the risk of becoming resistant is better than shooting yourself!), taking the antibiotics at a different time of day, taking one at one time and another at another time, or taking them fewer times a week. Or you could try not taking antibiotics at all and rather clearing your lungs of phlegm morning and night (or more often) for 30 minutes each time (some people do it for up to two hours) using an Aerobika, Acapella, or vibrating vest (with or without a saline inhalation). If your doctor can’t work with an alternative approach to antibiotics that trigger colitis, you should seek other opinions.

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