Ensifentrine - Trial for Non-cystic fibrosis Bronchiectasis patients
I spoke to my pulmonologist yesterday and she told me there is a trial for Ensifentrine (Verona study) that was originally a trial for COPD patients. It's an inhaled medication and FDA approved. The trial is being extended to patients with bronchiectasis. You can find out more and see trial locations and eligibility here:
https://ctv.veeva.com/study/a-phase-ii-study-of-ensifentrine-in-non-cystic-fibrosis-bronchiectasis
Interested in more discussions like this? Go to the MAC & Bronchiectasis Support Group.
Do you plan to participate? It looked interesting especially since it was a relatively short trial. From my reading here it's gotten mixed results from the COPD world. I might be wrong but I think blood work was involved in this study (liver toxicity?). All things being equal, I'd rather participate in a tablet based study and not add to my neb time unless there are very very clear benefits. I am interested in what you think.
@scoop
I’m not sure and don’t know a lot of the details as far as effectiveness and specifics for how it helps our condition. From what mr doctor said, she has seen good results with reducing time between exacerbations. Dr. Addrizzo said depending on my next CT scan she’ll either recommend treating my MAC or if things looks stable, she’ll have me speak with the clinical trial team about this trial so I’ll keep you posted. My next CT and PFT is July 7th so will let you know what I hear from the trial team.
Thanks for the website link. I read the exclusion criteria and current treatment for MAC is one of them.
I was told that the inhaled drug only takes 5 minutes to finish, mainly staying in the lungs. Dr. Kevin Winthrop is the principal investigator. I am thinking about participation if it truly reduces the airway inflammation. Isn't the inhaled version better than a pill?
Ling
@winema Yes, that's correct. Patients currently being treated for MAC are not eligible
Exclusion criteria
Quote: Current treatment for nontuberculous mycobacterial lung infection, allergic bronchopulmonary aspergillosis, or tuberculosis.
@ling Please keep us posted should you decide to move forward with the study. I reviewed my notes and at the time of reading the consent form I decided it wasn't for me because of the # of blood draws required. I really don't like getting lab draws. I work hard to combine them among my doctors to cut down on the # of sticks! Unfortunately these draws cannot be used for annual checkups etc. Apparently the blood is sent off to a lab that's helping conduct the study.
Hi scoop, I will let you know after I clarify about the number of the blood draws needed for this trial.
Ling
I have talked to a person who is involved in the trial. She said the blood draws needed for this trial is 7, which includes the blood work for PK sub-stdy regardless if you participate in the sub-study or not. It looks like that they closely monitor what is going on in your body during the trial.
Ling
@wangling @scoop I spoke to Dr. Addrizzo today at NYU. I have this pesky staph aureus colonization that seems likely to stay. Already tried hitting it with 28d of doxy and It came back a month later. I am nervous about leaving it to fester but also worried about drug resistance happening. Dr. Addrizzo said it's very hard to get rid of and usually comes back so choosing not to treat it unless I feel bad, which right now I don't. All that to say, she recommended I participate in the Ensifentrine trial right away. She thinks it will help with the inflammation so I'm going to start the screening process etc.,
After reading about Bresocatib, I feel more comfortable with the idea of the Ensifentrine mostly because it's inhaled—going directly into the lungs and doesn't have the side effects involving the teeth and skin which concerns me. I'll keep you both posted. @wangling did you end up starting the trial after all?
My only hesitation with participating is that I might get placed in the placebo group and then I won't be getting the drug at all but I suppose if the staph starts wreaking havoc, I'll just get put back on antibiotics either way.
There's another trial that they aren't recruiting for yet called Airtivity (Boehringer Ingelheim)
It's also a once a day tablet, similar to Brensocatib.
Trial: https://clinicaltrials.gov/study/NCT06872892?term=AIRTIVITY&rank=1&cookie_consent=yes
Good info thanks. I considered the Ensifentrine trial also but decided against it as it seemed there were frequent blood draws, which I really don’t like. The lab draws, from my understanding, are sent to an offsite lab and cannot be used for monitoring other things. So if you needed to have your thyroid checked, for example, it might require a different stick at a different time. Like I say I avoid extra draws and when I need labs I like to consolidate them.
It's good news that Ensifentrine has been approved in the US under the name Ohtuvayr to treat chronic obstructive pulmonary (lung) disease (COPD).