Beyond Air study using N.O. For MAC and Abscessus

Posted by cate123456 @cate123456, Aug 29 8:57am

Not sure if this has been posted here before, but I've been following their study, and it is now complete, but I'm having trouble getting the full results from them. I will continue to try contacting them for the sputum results.
Apparently this machine (Lungfit) will be able to be used in our homes to breath N.O. Into our lungs to kill the bacteria with safety to our lungs. The study was done in conjunction with the Cystic Fibrosis Foundation.
Here are the test results?? but they haven't posted the sputum samples or how well it cleared any NTMs.
Maybe the authorities here on the forum will have better success getting the information.

Fingers crossed!
https://www.beyondair.net/wp-content/uploads/2022/06/Thomson_C28_NTMFinal.pdf

Interested in more discussions like this? Go to the MAC & Bronchiectasis group.

Here is information on the company and links to their research and studies.
https://www.beyondair.net/

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@cate123456

Here is information on the company and links to their research and studies.
https://www.beyondair.net/

Jump to this post

This sounds like it will be another great tool – when it is available. As far as I can tell, the full report does not exist yet.
Take a look at this diagram:
https://www.beyondair.net/pipeline/
Let's translate the steps:
Preclinical – up to 3 years – the planning and proposal stage – getting permission to try on humans, manufacturing prototypes, getting candidates (done)
Pilot – usually 1-2 years- the initial small study – in this case it was 15 patients in Australia (almost done – data needs to be analyzed)
Pivotal – usually 2-3 years -the FDA required Phase III Clinical study – more people, more places, broader population, longer duration, with follow-up for long-term effectiveness and risks (paperwork undoubtedly started and awaiting final data from step 2)
PreMarket Approval – usually 2-3 years – Complete documentation to the FDA which is then reviewed
Commercial – ??? – funding, manufacturing & getting health insurance to cover.

Optimistically, I would say we are at least 5 years away from this treatment being even available. If NJH, Mayo, University of Texas – Tyler or another Lung Center gets involved, it is possible their patients could get into the clinical trials.
Let's hope this is going to be an option going forward!
Sue

REPLY
@sueinmn

This sounds like it will be another great tool – when it is available. As far as I can tell, the full report does not exist yet.
Take a look at this diagram:
https://www.beyondair.net/pipeline/
Let's translate the steps:
Preclinical – up to 3 years – the planning and proposal stage – getting permission to try on humans, manufacturing prototypes, getting candidates (done)
Pilot – usually 1-2 years- the initial small study – in this case it was 15 patients in Australia (almost done – data needs to be analyzed)
Pivotal – usually 2-3 years -the FDA required Phase III Clinical study – more people, more places, broader population, longer duration, with follow-up for long-term effectiveness and risks (paperwork undoubtedly started and awaiting final data from step 2)
PreMarket Approval – usually 2-3 years – Complete documentation to the FDA which is then reviewed
Commercial – ??? – funding, manufacturing & getting health insurance to cover.

Optimistically, I would say we are at least 5 years away from this treatment being even available. If NJH, Mayo, University of Texas – Tyler or another Lung Center gets involved, it is possible their patients could get into the clinical trials.
Let's hope this is going to be an option going forward!
Sue

Jump to this post

Thank you SAINT SUE for sorting through all that data.
I received an email from them saying the study was completed (???), so I didn’t realize it would take so long to jump through all those other hoops. Rats….

Someone did finally call back this morning, and they said they think the sputum samples have not matured yet in the lab, they will research it and get back to me. I will ask them how long they think it will take to finish the whole testing shebang.
It says on that pipeline under home use for NTM that the full data is in.
Both the safety aspect (so far so good) and the sputum
results will be our guide if this is worth pursuing.

REPLY
@cate123456

Thank you SAINT SUE for sorting through all that data.
I received an email from them saying the study was completed (???), so I didn’t realize it would take so long to jump through all those other hoops. Rats….

Someone did finally call back this morning, and they said they think the sputum samples have not matured yet in the lab, they will research it and get back to me. I will ask them how long they think it will take to finish the whole testing shebang.
It says on that pipeline under home use for NTM that the full data is in.
Both the safety aspect (so far so good) and the sputum
results will be our guide if this is worth pursuing.

Jump to this post

Yes, the dataset may be in, but…next comes that data analysis. In order to advance to the next phase – the Pivotal study, they will need to demonstrate that the results & safety are equal to or better than traditional (i.e. antibiotic) therapy. So numbers need to be compiled, compared & the reports written & submitted. I can't tell if this will be in Australia or the US, and if there is a difference in the processes.
Sue

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I’ll be sure to keep you informed if I get any new info.
They are bad about returning calls or emails.

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