Abstract Rationale Ohtuvayre™ (ensifentrine) was approved in June 2024 and is the first new inhaled maintenance therapy for COPD in over 20 years, with a novel dual-action mechanism (PDE3 and PDE4 inhibition) that provides both bronchodilation and anti-inflammation. The focus group objective was to obtain patient feedback and perspectives on treatment with Ohtuvayre at two consecutive discussions 3-6 months apart. Methods The questions were developed, implemented and reported by the GAAPP Research team in consultation with clinician experts. BRANY, NY IRB reviewed and approved the protocol, consent and interview guide. Six participants were recruited by staff at one specialist clinic in Denison, Texas. Following a screening process and consent, sessions 1 and 2 were conducted as GAAPP led Zoom/phone interview in May and October of 2025. Unrestricted funding was obtained from Verona, the manufacturer of ensifentrine, but the funder did not engage in the study. Results Out of 6 participants of the focus group, all reported significant burden of COPD prior to treatment including symptoms, activity limitation, frequent flare ups, and anxiety (Figure), all but 1 occasional smoker are former smokers. Most experienced early respiratory symptoms (shortness of breath, bronchitis) for several years before being diagnosed with COPD. All participants recall using many different medications plus oxygen and rescue inhalers before starting Ohtuvayre treatment. All 6 participants have been using Ohtuvayre for 4-5 months at the time of the first focus group and 9-10 months on the second. All participants specifically report no recent flare-ups or exacerbations since starting Ohtuvayre. All participants describe increased physical ability (e.g., walking, exercising, yoga, traveling without a walker, or completing household tasks); (Figure). One out of the 6 participants mentioned a side-effect attributed to the treatment: temporary congestion or difficulty inhaling and “shaking” (tremulousness) immediately after taking the medicine which both resolved shortly afterward; however, this did not preclude the participant’s adherence to treatment. Three participants initially encountered some issues with nebulizer parts (tubing, preparation, and compatibility with different medications). Three others thought it was very easy and manageable. All the usability issues improved 5 months later. Conclusions Patient initial impressions highlight meaningful improvements in quality of life and physical function supporting continued research into ensifentrine as a therapy for COPD and related conditions. This abstract is funded by: Verona Pharma
Tal-Singer et al. (Fri,) studied this question.