COPD Clinical Trial
Official title:
Sedation and Physiological Effects of Intranasal Dexmedetomidine in Severe COPD
A variety of medications have been used to treat the anxiety, discomfort, and fear associated
with continuous and sudden episodic breathlessness in patients with advanced respiratory
disease. Opioids and benzodiazepines, used alone or in combination, are commonly prescribed
for this distressing symptom. Clinicians are concerned about the adverse effects of opioids,
especially respiratory depression, so they frequently prescribe benzodiazepines. Recent
studies have shown that benzodiazepine use is associated with increased adverse respiratory
outcomes in older adults with Chronic Obstructive Pulmonary Disease (COPD).
Dexmedetomidine may be an alternative to current drug therapies for breathlessness.
Dexmedetomidine produces a dose dependent sedation, anxiolysis, and analgesia without
respiratory depression or cognitive dysfunction. The drug can be administered intranasally to
induce light to moderate sedation of several hours duration.
The objective of the proposed research, a pilot study, is to assess the dose dependent safety
and efficacy of intranasal dexmedetomidine in clinically stable patients with severe COPD.
This will be accomplished in a staffed acute care setting with routine vital signs monitoring
and pulse oximetry. Patients will be assessed objectively and subjectively for their level of
sedation by validated sedation scales.
This pilot study is an initial investigation of a drug with favorable pharmacologic
properties in this patient population with distressing and difficult to treat symptoms. The
pilot study may provide evidence that a larger trial is needed to confirm the study results,
or evidence that additional study in symptomatic patients and treatment comparison trials
should be pursued.
n/a
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