Midazolam Nasal Spray for the treatment of breathlessness in patients with life-limiting disease

Dyspnoea, defined as an uncomfortable sensation of breathing (which is often reported by patients as breathlessness), is a common symptom affecting up to 80% of cancer patients and 95% of patients with chronic obstructive pulmonary disease (COPD). Nearly half of all patients requiring palliative care report breathlessness as a problem during the last year of life. Moreover, dyspnoea is consistently high-lighted as a poor prognostic factor and harbinger of impending death. Ventilatory drive is the net result of complex automatic and subconscious, peripheral and central, neural and chemical mechanisms. Dyspnoea is the conscious perception which has taken account of the net result of those mechanisms and integrated it with other cognitive and emotive factors that are also affecting the individual. Dyspnoea is thus a subjective symptom that is debilitating to patients, impacting greatly on quality of life of both patient and carer. It is a challenging symptom to manage and is often impossible to reverse despite maximal treatment of the underlying cause. Anxiety is often reported by patients as a major component of breathlessness with breathlessness leading to anxiety and anxiety exacerbating breathlessness leading to a progressive spiral of cause and effect. Hypothesis : Intranasal midazolam is superior to placebo for the palliation of dyspnoea in patients with optimally treated life limiting disease