Successful phase 2/3 study with Heparin delivered with Pulmospray

Istanbul University has used Pulmospray to deliver inhaled Heparin to COVID patients with promising results.

The University of Istanbul with investigators Prof. Mustafa Erelel and Prof. Ayca Yildiz Pekoz recently completed a clinical study on COVID-19 with the Pulmospray® inhaler from Resyca. The endpoints of the study were improvement in clinical status (e.g. hypoxemia) and length of stay in the intensive care unit (ICU).

The Pulmospray® inhaler was used with the actuation accessory Respi Lever Drive™ to deliver the the liquid low molecular weight heparin formulation in a single use, single patient application to the lungs. Resyca donated the devices being manufactured by Medspray to this COVID-19 research program at the start of the pandemic. Resyca has supported the investigators by aerosol characterisation studies, deposition modelling studies, clinical trial supply and services and regulatory support for the clinical trial submissions.

Investigators indicated promising results of the study that included 80 patients, whereof 40 patients inhaled heparin with the Pulmospray. Clinical trial results suggest that low molecular weight heparin inhalation with Pulmospray may be a treatment option to reduce intensive care and improve clinical status. Positive results also indicate that the Pulmospray inhaler was applied effectively by clinical trial staff and users in a single use, single patient application in the infectious disease COVID-19.

The publication of study results was submitted for publication and is currently in review. The results have already been published at clinical trials dot gov, see https://clinicaltrials.gov/ct2/show/NCT04990830