Placebo Controlled Evaluation of Sedation and Physiological Response to Intranasal Dexmedetomidine in Severe COPD
Status:
Withdrawn
Trial end date:
2018-04-01
Target enrollment:
Participant gender:
Summary
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 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 (IN-DEX) to induce light to moderate sedation of
several hours duration.
The objective of the research is to assess the dose dependent safety and efficacy of
intranasal dexmedetomidine compared to intranasal saline (placebo) in clinically stable
patients with severe COPD. This will be accomplished in a staffed acute care setting with
routine vital signs monitoring and continuous pulse oximetry. Patients will be assessed
objectively and subjectively for their level of sedation by validated sedation scales.
The study is an extension of a similarly designed pilot study which did not include a placebo
comparison. Results of the study will be helpful to design additional trials with intranasal
dexmedetomidine in acutely symptomatic COPD patients, exertional dyspnea and exercise
performance, and dyspnea treatment comparisons.