Boehringer Ingelheim AIRTIVITY clinical trial
Anyone considering participating in this clinical trial?
https://www.boehringer-ingelheim.com/human-health/lung-diseases/bronchiectasis/phase-iii-airtivity-trial
Interested in more discussions like this? Go to the MAC & Bronchiectasis Support Group.
My understanding is that Airtivity is a DPP1 inhibitor similar to brensocatib but with different mechanism of action. It's a ways out for trial completion, 2028. Sigh.
Sue,
Do you know if this study would be appropriate for someone with MAC?
Thanks,
Lynn
I'm not sure - there are several trials in progress or ramping up, some accept people with MAC, some do not. The best way to find out is to sign up and have them contact you.
Thank you!
https://airtivity.researchstudytrial.com/?cookie_consent=no
Is it the same as this?
Yes
Exclusions:
-Any new or newly diagnosed condition of primary or secondary immunodeficiency within 1 year before randomisation.
-Allergic bronchopulmonary aspergillosis being treated or requiring treatment.
***Tuberculosis or non-tuberculosis mycobacterial infection being treated or requiring treatment***
-Any findings in the medical examination and/or laboratory value assessed at Screening Visit 1 or during screening period, that in the opinion of the investigator may put the participant at risk by participating in the trial.
-Any clinically relevant (at the discretion of the investigator) acute respiratory infection or ongoing pulmonary exacerbation at screening visit or during the screening unless recovered in the opinion of the investigator prior to Visit 2.
-Any relevant pulmonary, gastrointestinal, hepatic, renal, cardiovascular, metabolic, immunological, hormonal, or other disorder that, in the opinion of the investigator, may put the participant at risk by participating in the study.
-Major surgery (major according to the investigator's assessment) performed within 6 weeks prior to randomisation or scheduled during trial period.
-Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated in situ non-melanoma skin cancers or in situ carcinoma of uterine cervix.
-Evidence or medical history of moderate or severe liver disease (Child-Pugh score B or C hepatic impairment).
estimated Glomerular Filtration Rate (eGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula < 30 mL/min at Visit 1.
-Previous treatment with a dipeptidyl peptidase-1 (DPP1) (Cathepsin C (CatC)) inhibitor. (Note: Participants that were randomised and only received placebo in studies with DPP1 (CatC) inhibitor are allowed.) Further exclusion criteria apply.
Linda Esposito
Here’s a Veeva link with inclusion and exclusion criteria and trial locations :
https://ctv.veeva.com/study/the-airtivity-r-study-a-study-to-find-out-whether-bi-1291583-helps-people-with-bronchiectasis
Looks like I won't qualify due to NTM. Well dang. Good luck to all participants.
But if you enroll you might be on the drug for the length of the trial. And probably after as well. That was the case for brensocatib. Even if you were on the placebo, you were giving me the option after completing the trial to go on the drug. I know someone in New Zealand, who was on the drug during the trial and then continued. For her, it was life-changing.