ARINA-1 Clinical Trial with nebulized solution-NO ANTIBIOTICS

Posted by becleartoday @becleartoday, Aug 17, 2023

GOOD NEWS!!!

We have been asking for bronchiectasis treatments that are not antibiotics, and we have been heard!

Dr. Charles Daley is a well-respected expert from National Jewish Health in Denver. He was a keynote speaker at the World Bronchiectasis Conference and gave the closing remarks.

Dr. Daley is also the principal investigator of a study evaluating ARINA-1, a nebulized solution manufactured by Renovion that has been shown to prevent mucus from clogging our airways. Clogged airways cause inflammation and infection, a cycle we try to break with daily airway clearance and, often, antibiotics.

ARINA-1 is a sterile formulation that is manufactured under strict guidelines. The solution includes glutathione, ascorbic acid, and a buffer to modify the pH.

The trial will measure ARINA-1’s impact on quality of life, mucus viscosity, and inflammation.

Researchers are looking for 25 more participants for the 28-day study. Participants need to be diagnosed with non-CF bronchiectasis and have mucus. In addition to National Jewish in Denver, trial sites are located in Baltimore; Philadelphia; Seattle; Birmingham, AL; New Orleans; Tyler, TX; Winston-Salem, NC; Portland, OR; and Charleston, SC. If you live in or around one of these areas and are interested in the trial, let me know.

Click on the following link to clinicaltrials.gov for more information on the ARINA-1 trial.

https://tinyurl.com/tsh6fjnr

I am working with Renovion and researchers to share this opportunity, and I can help answer basic questions regarding:

-Participating doctors
-Laboratory studies of ARINA-1
-How nebulizing this solution differs from nebulizing glutathione alone or orally administered NAC
-The importance of the combination of glutathione and ascorbic acid

If you have other questions about the trial, the drug or how to enroll, let me know and I can help you get an answer from the Chief Scientific Officer at Renovion who is a great resource.

Most importantly, discuss this trial with your doctor.

Dr. Daley implored us to get involved in bronchiectasis and NTM research. Let’s show him and the researchers working on our behalf that we are willing to participate whenever possible.

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

Fantastic @becleartoday ! Small steps forward welcome. Thanks for keeping us up to date with the latest research.

Here's a link to the original research with CF patients in mind. CFERS have it far worse than us given it usually begins in infancy/childhood. What might help CF might also help those with non CF bronchiectasis. Fingers crossed...

https://www.atsjournals.org/doi/pdf/10.1165/rcmb.2019-0287OC
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I forgot to include Washington, DC. Seattle is not a test site. Sorry!

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@scoop

Fantastic @becleartoday ! Small steps forward welcome. Thanks for keeping us up to date with the latest research.

Here's a link to the original research with CF patients in mind. CFERS have it far worse than us given it usually begins in infancy/childhood. What might help CF might also help those with non CF bronchiectasis. Fingers crossed...

https://www.atsjournals.org/doi/pdf/10.1165/rcmb.2019-0287OC

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Thank you Scoop. This sounds promising. Yes, fingers-crossed!

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Linda, In my last visit I brought Arina-1 up to my Pulmo. It was clear he had not heard of it. I just messaged him about the study you posted. Dr Douglas Hornick in the specialty pulmonary department at the University of Iowa Hospitals and Clinics. He specializes in Cystic Fibrosis and Bronchiectasis, difficult pulmonary infections etc. I would love for U of IA to be included if they are receptive. Is there any way to facilitate that? also I would very much like to know the difference between nebulizing Arina-1 and glutathione mixed with saline. I try to do that every other day. I would love to get involved but nothing is close to me. I do produce abundant mucus! And have chronic Pseudomonas. Also wondered if any of the Drs discussed the use of CFTR modulators for NCFBE? I have been reading there is some thought of that? It has been such a huge game changer for the CF people. THANK YOU for all you are doing!

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@scoop

Fantastic @becleartoday ! Small steps forward welcome. Thanks for keeping us up to date with the latest research.

Here's a link to the original research with CF patients in mind. CFERS have it far worse than us given it usually begins in infancy/childhood. What might help CF might also help those with non CF bronchiectasis. Fingers crossed...

https://www.atsjournals.org/doi/pdf/10.1165/rcmb.2019-0287OC

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I already nebulize Glutathione with Bicarbonate (mentioned in a previous posting recently). So I assume the only difference would be the ascorbic acid. So I am eager to hear just why that is so important. In previous post I said I was not sure how much the glutathione was helping so I reduced the use. But started to get quite sick lately. Could be a coincidence but I am going to go back to using it every other day in case it was helping more than I thought.

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@irenea8

Linda, In my last visit I brought Arina-1 up to my Pulmo. It was clear he had not heard of it. I just messaged him about the study you posted. Dr Douglas Hornick in the specialty pulmonary department at the University of Iowa Hospitals and Clinics. He specializes in Cystic Fibrosis and Bronchiectasis, difficult pulmonary infections etc. I would love for U of IA to be included if they are receptive. Is there any way to facilitate that? also I would very much like to know the difference between nebulizing Arina-1 and glutathione mixed with saline. I try to do that every other day. I would love to get involved but nothing is close to me. I do produce abundant mucus! And have chronic Pseudomonas. Also wondered if any of the Drs discussed the use of CFTR modulators for NCFBE? I have been reading there is some thought of that? It has been such a huge game changer for the CF people. THANK YOU for all you are doing!

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Hi Irene,
The researchers only need 25 more participants and are not enrolling new test sites.

I'm sorry to hear you produce an abundant amount of sputum. I'm sure it impacts your quality of life and I am hoping ARINA-1 comes to market and makes your life easier. From attending the World Bronchiectasis Conference, I also know there are also other trials addressing pseudomonas.

I knew someone would ask about nebulizing glutathione and how it compares to ARINA-1. I discussed this topic with Renovion and this is what they said, "ARINA-1 is a pH-balanced, sterile formulation that is manufactured under strict manufacturing guidelines that ensures the product is exactly as it should be and is of the highest quality and is sterile. Supplements you purchase online are not regulated and do not necessarily follow strict manufacturing and testing guidelines, so the contents and sterility of the product may be questionable to unsafe to inhale.

Further, the inclusion of ascorbic acid into the formulation is critical because glutathione and ascorbic acid work together in the glutathione-ascorbic acid cycle. Without ascorbic acid, glutathione is unable to perform all the innate immune functions that are required to decrease mucus viscosity, move mucus out of the airway, and decrease inflammation. Ascorbic acid and glutathione work in a complementary fashion and both are critical to restoring innate immune defenses, such as mucociliary clearance and downregulating inflammatory processes. One or the other is inadequate.

Supplementing high doses of ascorbic acid orally can be dangerous and lead to side effects such as severe gastrointestinal distress and renal dysfunction and failure. Further, it will not get to the lungs, where the ascorbic acid is needed most.

Inhaling products that are not made under strict Good Manufacturing Practices (GMP), including follow-up testing to ensure the product is not degrading and maintains sterility, can be very dangerous to the health of the patient."

Please let me know if this is clear. Thank you for your interest in participating in a clinical trial to move BE/NTM research forward! Warm regards, Linda

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@becleartoday

Hi Irene,
The researchers only need 25 more participants and are not enrolling new test sites.

I'm sorry to hear you produce an abundant amount of sputum. I'm sure it impacts your quality of life and I am hoping ARINA-1 comes to market and makes your life easier. From attending the World Bronchiectasis Conference, I also know there are also other trials addressing pseudomonas.

I knew someone would ask about nebulizing glutathione and how it compares to ARINA-1. I discussed this topic with Renovion and this is what they said, "ARINA-1 is a pH-balanced, sterile formulation that is manufactured under strict manufacturing guidelines that ensures the product is exactly as it should be and is of the highest quality and is sterile. Supplements you purchase online are not regulated and do not necessarily follow strict manufacturing and testing guidelines, so the contents and sterility of the product may be questionable to unsafe to inhale.

Further, the inclusion of ascorbic acid into the formulation is critical because glutathione and ascorbic acid work together in the glutathione-ascorbic acid cycle. Without ascorbic acid, glutathione is unable to perform all the innate immune functions that are required to decrease mucus viscosity, move mucus out of the airway, and decrease inflammation. Ascorbic acid and glutathione work in a complementary fashion and both are critical to restoring innate immune defenses, such as mucociliary clearance and downregulating inflammatory processes. One or the other is inadequate.

Supplementing high doses of ascorbic acid orally can be dangerous and lead to side effects such as severe gastrointestinal distress and renal dysfunction and failure. Further, it will not get to the lungs, where the ascorbic acid is needed most.

Inhaling products that are not made under strict Good Manufacturing Practices (GMP), including follow-up testing to ensure the product is not degrading and maintains sterility, can be very dangerous to the health of the patient."

Please let me know if this is clear. Thank you for your interest in participating in a clinical trial to move BE/NTM research forward! Warm regards, Linda

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yes thanks. I think the glutathione bicarbonate from Thera naturals is safe (sure hope so) but the addition of the Ascorbic acid does sound important. I wonder if you mix it with Saline (Arina-1)? Or if you do it in addition to saline. I would not want to do without hypertonic saline. If my Dr responds to my message today I will let him know they do not need new test sites. Any new promise for pseudomonas I would love to hear about.

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@irenea8

I already nebulize Glutathione with Bicarbonate (mentioned in a previous posting recently). So I assume the only difference would be the ascorbic acid. So I am eager to hear just why that is so important. In previous post I said I was not sure how much the glutathione was helping so I reduced the use. But started to get quite sick lately. Could be a coincidence but I am going to go back to using it every other day in case it was helping more than I thought.

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@irenea8 where do you buy the Glutathione? Mine comes from THERAnaturals but it's been awhile since I refreshed by supply. Along with nebbing, I occasionally took it sublingually.

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@scoop

@irenea8 where do you buy the Glutathione? Mine comes from THERAnaturals but it's been awhile since I refreshed by supply. Along with nebbing, I occasionally took it sublingually.

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Yes TheraNaturals is the best one and what I use. I believe it is quite sterile. I have some other kind of glutathione for sublingual use but only tried it once. Do you find it helpful?

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I also have been using gluthathione, though just in normal sterilised saline solution, since I was diagnosed with bronchiectasis several years ago. I started using it because there is good evidence from a few decades ago that this treatment helps people with Cystic Fibrosis and bronchiectasis to get their mucus cleared.

Glutathione is naturally made in the liver and is used as part of the lung's own anti-flammatory responses. In people with bronchiectasis, the levels in the lung are much lower - presumably what is being made in the liver is being used up too quickly!

Just now looking into the more recent literature I see that there has been a successful trial reported in 2019 of bicarb/ascorbic/gluthathione inhalation for bronchiectasis, which this latest non CF bronchiectasis trial would appear to be based on ( reported at Am J Respir Cell Mol Biol Vol 63, Iss 3, pp 362–373, Sep 2020 )

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