1. < MAC & Bronchiectasis

Ensifentrine - Trial for Non-cystic fibrosis Bronchiectasis patients

Posted by kdiago1564 @kdiago1564, Jun 20 7:27am

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.

scoop | @scoop | Jun 20 9:29am

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.

REPLY
1 reply
kdiago1564 | @kdiago1564 | Jun 20 10:42am

@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.

REPLY
winema | @winema | Jun 21 12:34pm

Thanks for the website link. I read the exclusion criteria and current treatment for MAC is one of them.

REPLY
@ling | @wangling | Jun 21 2:37pm
In reply to @scoop "Do you plan to participate? It looked interesting especially since it was a relatively short trial...." + (show)
@scoop

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.

Jump to this post

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

REPLY
1 reply
kdiago1564 | @kdiago1564 | Jun 22 7:01am

@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.

REPLY
scoop | @scoop | Jun 22 8:06pm
In reply to @wangling "I was told that the inhaled drug only takes 5 minutes to finish, mainly staying in..." + (show)
@wangling

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

Jump to this post

@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.

REPLY
2 replies
@ling | @wangling | Jun 22 9:54pm
In reply to @scoop "@ling Please keep us posted should you decide to move forward with the study. I reviewed..." + (show)
@scoop

@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.

Jump to this post

Hi scoop, I will let you know after I clarify about the number of the blood draws needed for this trial.

Ling

REPLY
@ling | @wangling | Jun 23 6:03pm
In reply to @scoop "@ling Please keep us posted should you decide to move forward with the study. I reviewed..." + (show)
@scoop

@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.

Jump to this post

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

REPLY
Please sign in or register to post a reply.