chronic, life-limiting disease, Serious
Conditions
Brief summary
Self-rated breathlessness (ESAS-r) [21, 22] change from baseline at 60 minutes after the treatment was administered.
Detailed description
Self-rated breathlessness (ESAS-r), change from baseline at 30 minutes after the treatment was administered, Change from baseline for other symptoms (pain, tiredness, drowsiness, nausea, lack of appetite, depression, anxiety, wellbeing) self-rated using the ESAS-r, change from baseline at 60 minutes after the treatment was administered, Safety measures (SpO2, breathing rate, and level of consciousness [GCS]) change from baseline at 60 minutes after the treatment was administered, Adverse drug reactions (ADRs), defined as adverse events assessed as possibly or probably related to the investigational medicinal product and excluding events attributable to the natural course of the underlying disease, will be recorded at 60 minutes after treatment administration, prior to the next dose, and at the end of the trial., Date, place and cause(s) of death up to three months after date of first randomization in the trial
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Self-rated breathlessness (ESAS-r) [21, 22] change from baseline at 60 minutes after the treatment was administered. | — |
Secondary
| Measure | Time frame |
|---|---|
| Self-rated breathlessness (ESAS-r), change from baseline at 30 minutes after the treatment was administered, Change from baseline for other symptoms (pain, tiredness, drowsiness, nausea, lack of appetite, depression, anxiety, wellbeing) self-rated using the ESAS-r, change from baseline at 60 minutes after the treatment was administered, Safety measures (SpO2, breathing rate, and level of consciousness [GCS]) change from baseline at 60 minutes after the treatment was administered, Adverse drug reactions (ADRs), defined as adverse events assessed as possibly or probably related to the investigational medicinal product and excluding events attributable to the natural course of the underlying disease, will be recorded at 60 minutes after treatment administration, prior to the next dose, and at the end of the trial., Date, place and cause(s) of death up to three months after date of first randomization in the trial | — |