Ensifentrine - Trial for Non-cystic fibrosis Bronchiectasis patients

@kdiago1564, Sorry for the delayed response. We are on a road trip.
I am still in the process of the trial. My pulmonologist put me on brensocabit, I will give it a try. I am not sure if I should continue with the process for the trial. Simply believe that a drug is here to use and being tested. For the trial, I am not sure if I will get the drug or the placebo. I am in a hurry to treat my inflammations and prevent more exacerbations. But the trial might go on for a while, if after 16 weeks, my condition doesn't improve, I may still consider the trial. But I will talk to my ID doctor, Kevin Winthrop. He is the one who wanted me to be on the trial only because he didn't know the drug was on the market so soon. He thought it would be at the end of the year, by then I would finish the trial. This is my situation.

Ling

@wangling Don't worry about your response time! Road trip sounds more fun!

I feel conflicted about getting screened for the trial for the same reasons. If I have inflammation now, isn't it better to just get on an available drug proven to reduce inflammation right away? Confusing, honestly. 🤔

I'd be curious to hear what your ID doctor says and the logic behind one path vs. the other. I think the one and only downside of Brenso is the possibility of side effects but maybe they're not super common. Since I have a staph colonization, I feel like nipping inflammation in the bud is the priority.

Do you have frequent exacerbations? Have you been treated for MAC already? I know there are many factors that inform a treatment plan.

I have staph colonization too. My ID doctor said, 40% people have it. Just
because it is every where. It is very common. We can leave it alone.
What the saying goes? A bird in the hand is better than two in the bush. I
think it is logical to take brensocabit. In the ideal world, we don't want
to take any medications, I, personally a strong believer in natural healing
all my life. I was lucky enough, did not have to take anything. But after
I got BE, I realized, anything helps me to have a quality life is worth to
try. Life is short. Really.
Generally speaking medications are all bad in some ways, but they also
save lives. Not everyone has the side effects, only certain people have
it. This is just what I think. Hope it helps.

Ling

Thank you! @wangling I think the staph colonization causes me a lot of anxiety and I honestly don’t know if it can do a lot of damage or not but I just wish it wasn’t in there. So far I don’t have symptoms other than coughing up orange plugs and feeling fatigue.

I agree with you completely. Better to just take what’s available to avoid complications with recurrent infections. I will have to decide whether I try the trial or not. I hope you have a great road trip!! I really appreciate your thoughtful responses with all this.

Finally got cleared for this trial and get randomized on Wednesday so fingers crossed I get the drug! 🤞🤞🤞

@kdiago1564
Reviving this thread to see how the clinical trial of Ensifentrine is going for you. Do you think you're on placebo or Ensifentrine?

@scoop

Hi there! Sorry it's taken me ages to respond.

It's a great question. I started this trial in late December. In January I had hempotysis a couple of times. Pulmo put me on 10d of doxy. By Feb still had mild hemoptysis every so often—but enough that they considered it abnormal for someone with BE— and I tested positive for Moraxella, H. Flu and Corona 222E and so they put me on Levaquin which cleared up everything and I no longer had hemoptysis.

I haven't been sick or had any other hemoptysis since March

My pulmo said if I am on the drug (and not the placebo) it typically takes 6 months to really start showing results. I have no idea if I'm on the placebo. Back in Feb I would have said no, I don't think I'm on the drug, simply because I was getting sick. But I have a 4-yo and she brought a lot of bugs home (Morxaella is common in kids) and so I would say having a preschool aged child is a variable that this trial wouldn't have factored in. Drug or no drug, I'm not sure it would be possible for anyone to avoid getting sick under those circumstances. But, she was also sick in April and my wife had a nasty sinus infection coughing all over the place and I did NOT get sick in April so now I would say I DO think I'm on the drug because I haven't had any sickness and I'm just about at 6 months. But overall, I have no idea. I'm not sure how much longer the trial lasts, it's a big vague but I'm assuming through the summer at least.

I will say I have not had a single side effect and I like that this drug is inhaled and going straight to the lungs versus taking a pill.

I'm still doing airway clearance as consistently as possible (2x a day) and inhale the trial drug afterwards.

I will keep you posted and thank you for asking!

@kdiago1564
Thanks so much for the thorough reply. Yes, kids are vectors of disease and we are susceptible. Great that you have not had any sickness in 6 months. I agree with you that medication delivered directly to the lungs is preferable to a tablet that works systemically.

One other question: how have you found the clinical trial, is it onerous or manageable? When I looked at it there seemed to be a bunch of blood draws and lots of visits. On the other hand I think it lasts for just 6 months, which sounds doable.

@scoop

I believe the visits are every 6 weeks. Each visit lasts between 30m (shortest visit with least number of things happening) and then longer visits on occasion where you have to wait awhile between taking the inhaled medication and getting a PFT test. But all in all, I would say it's totally manageable and doesn't feel like too much.
- You fill out a questionnaire on an iPad each visit — same set of questions each time
- Each visit you bring in your Pari cup and inhale your morning dose during the visit. They supply you with a new set of Pari cups and tubing each visit to take home along with a refill of medication
- On some visits (not every) you have to do a pre-medication PFT test and then a post-medication PFT test
- There is a blood draw but not every time. Maybe every other
- There is an EKG, but again not each visit. I believe I had an EKG at the first couple of visit but then tapered off
- You get a brand new Pari ProNeb Max every 6 months
- You bring in all your full and empty boxes of medication each visit and they basically validate what you've taken etc,.
- At home, it's no worse than having to do airway clearance 2x / day. It's a bit longer because you add on the medication inhalation but that piece isn't too bad
- You have to take a questionnaire each night on your trial supplied cellphone. You can't miss doing that—considered almost as important as taking the medication

I would say my biggest challenge is adhering to my airway clearance routine and not missing medication (but this has always been my biggest challenge!) 🙂
I have missed one dose some days and you will get booted if you don't maintain 85% adherence but I haven't had an issue.

That's about it!

I actually don't mind the check-ins because on a few occasions I was sick so I could see Dr. Addrizzo and check-in with my researcher and they work so closely that Dr. Addrizzo would fill Dr. Lau the research doctor in if I was sick and vice versa.

@kdiago1564
I did a different study with Dr Lau and had the same experience of Dr Lau alerting Dr Adrizzo if I looked like I might be starting to flare, new symptoms etc + vice versa. It's very reassuring. I think we are very lucky to have our clinical doctor and our study doctor right there in the same office.