Pub Date : 2026-01-01DOI: 10.1016/j.clinthera.2025.11.004
Manan M. Nayak PhD, MA , Peter R. Chai MD, MS , Stephanie Tung MD , Anna Revette PhD , Ilana M. Braun MD
Purpose
Medical cannabis (MC) is used by 1 in 3 patients with cancer. Scientific work suggests a disconnect between patients’ cannabis therapeutics practices and oncologists’ clinical preferences. This qualitative study explores the preferences of patients with cancer as they relate to MC formulations, administration routes, and dosing.
Methods
Semistructured interviews were conducted with patients with cancer consuming MC in 8 states and examined using thematic analysis.
Findings
Among study participants (N = 24), the mean age was 54 years, 67% were female, and 51% had metastatic disease. A powerful theme identified across interviews was of myriad MC dispensary product formulations, triggering astonishment and burden. Common strategies among participants included purchasing and sampling multiple store-bought formulations, modifying dispensary products, and altering intended routes of administration. Preferred dispensary products were not consistently available. Top-cited modes of administration included oral, followed by topical, sublingual, vaporization, combustion, and rectal suppository. Three-quarters of participants alternated between modes. Medical cannabis dosing imprecision represented another powerful theme due to the lack of dispensary quality assurance and accuracy in home measurements.
Implications
This investigation suggests that MC preparations, dosing, and administration routes vary among patients with cancer, and that common consumption patterns (for instance, reliance on multiple routes of cannabis administration) are not rooted in science. Although these findings should be further interrogated, they suggest a need for lay-facing cannabis therapeutics education and standardization of dispensary products to strengthen cannabis-related care.
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Pub Date : 2026-01-01DOI: 10.1016/j.clinthera.2025.10.011
Hitesh Pandya MBChB, MD , Mehul Patel MBBS, PhD, FRCP , Michael Gillen BS, PhD , Jitendar Reddy MPharm , Artur Bednarczyk MD , Marek Kokot MD, MBA , Yubo Tan MSc , Maria Heijer MSc , Magdalena Andersson MSc, MSBA , David Petullo MSc , Mandeep Jassal MD
Purpose
Hydrofluoroalkane-134a (HFA-134a), the propellant in the marketed budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF) formulation, has a global warming potential (GWP) that falls above environmental regulation thresholds and therefore will be phased out. With global efforts to minimize carbon emissions, the hydrofluoroolefin-1234ze (HFO-1234ze) propellant, with a >99% lower GWP than HFA-134a, is in development for pressurized metered-dose inhalers (pMDIs). Spacers support drug delivery in patients with poor pMDI inhalation technique, but it is unknown if BGF exposure with HFO-1234ze exceeds that observed with HFA-134a when using a spacer.
Methods
This Phase I study assessed systemic BGF component exposure with HFO-1234ze versus HFA-134a when using a spacer, and for HFO-1234ze with and without a spacer. Participants (N = 42) were randomized to BGF with HFA-134a with a spacer (reference), HFO-1234ze with a spacer (test), and HFO-1234ze without a spacer (descriptive treatment) over 3 treatment periods in 1 of 6 sequences. As spacer devices help to increase exposure, the upper limit of the 90% confidence interval (CI) of geometric mean ratios (GMRs) was of interest, and bioequivalence was not included as a study objective.
Findings
Analyses demonstrated the upper 90% CI of the GMRs for maximum observed plasma concentration (Cmax) and area under the plasma concentration curve from time zero to the time of the last quantifiable concentration (AUClast) were <125% for all BGF components for HFO-1234ze versus HFA-134a when using a spacer, indicating exposure with HFO-1234ze did not exceed exposure with HFA-134a. Additionally, Cmax was increased for all BGF components with HFO-1234ze when using versus not using a spacer, with the largest increases observed among participants with the lowest exposure when not using a spacer, likely due to poor inhalation technique. No new safety findings, and no deaths or serious adverse events, occurred during the study.
Implications
These findings provide evidence that may help to support the future use of HFO-1234ze propellant in BGF pMDIs.
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