Sedana Medical clinical studies

The Sedaconda study

In 2020, Sedana Medical completed the Sedaconda study (SED001), the largest randomised, controlled, open-label trial performed to date on inhaled sedation in intensive care.

The phase III study aimed to confirm the efficacy and safety of sedation with Sedaconda (isoflurane) delivered via the Sedaconda ACD in mechanically ventilated ICU patients, comparing it to standard sedation with intravenously administered propofol. A total of 301 patients from 24 intensive care clinics in Germany and Slovenia were randomized to either sedation method.

The study successfully reached its primary endpoint, demonstrating Sedaconda’s non-inferiority to intravenous propofol in maintaining an adequate depth of sedation. Additionally, the results showed that sedation with Sedaconda reduced the need for opioids, facilitated spontaneous breathing, and enabled a faster and more predictable awakening. In terms of safety, Sedaconda was well tolerated, with a safety profile consistent with previous findings for isoflurane. Taken together, the Sedaconda study results confirm the clinical experience of inhaled sedation as an effective and safe method of sedation.

The results were published in The Lancet Respiratory Medicine journal (Meiser et al., 2021) and constituted the basis for Sedana Medical's European marketing approval for Sedaconda for inhaled sedation. 

 

The IsoCOMFORT study

In 2021, Sedana Medical initiated the IsoCOMFORT study (SED002), a paediatric phase III study aiming to investigate whether sedation with Sedaconda (isoflurane) delivered via the Sedaconda ACD, is safe and more effective than intravenously administered midazolam in mechanically ventilated ICU paediatric patients between 3-17 years old.

Currently, midazolam is the only sedation option for children in ICU because propofol is contraindicated due to the risk of serious adverse events. The patients will be sedated for 12–48 hours with either sedation method, and the primary endpoint will be the proportion of time spent at adequate sedation depth.

The study will involve 160 patients from intensive care clinics in Germany, France, Spain, Sweden, and the UK, and completion is estimated for the second half of 2022. The results of the study are expected to lead to an approved paediatric indication for inhaled sedation.

Further information on the study is available at www.clinicaltrials.gov (NCT04684238).

Sedana Medical Clinical Studies

The INSPiRE-ICU 1 & INSPiRE-ICU 2

The INSPiRE-ICU (Inhaled Sedation vs Propofol in Respiratory failure) studies (SED003 and SED004) are two identical phase III studies aiming to confirm the efficacy and safety of inhaled isoflurane, delivered via the Sedaconda ACD, for the sedation of adult mechanically ventilated ICU patients, in comparison to intravenous infusion of propofol.

The results of the studies will form the basis of a new drug application (NDA) filing at the US Food and Drug Administration (FDA). 

The primary endpoint will be the proportion of time spent within the target range of sedation depth in absence of rescue sedation, as assessed according to the Richmond Agitation Sedation Scale (RASS). In addition, the studies will investigate several secondary endpoints, including the use of opioids, the wake-up time, the cognitive recovery after end of sedation, and the spontaneous breathing effort.

The studies will enrol a total of 470 adult patients across 25-30 sites in the US. Patient recruitment is estimated to be completed in 2023. The first patient was enrolled in April 2022.

Further information on the studies is available at www.clinicaltrials.gov (NCT05312385 for SED003 and NCT05327296 for SED004).