A Phase 4 interventional study of IN-DEX 1.0 mcg/kg, intranasal saline and IN-DEX 1.5 mcg/kg, intranasal saline in COPD, sponsored by Dayton VA Medical Center. Withdrawn at 1 site in United States. Open to participants aged 45 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-07-31.
Sponsored by Dayton VA Medical Center · Phase 4, Interventional, and Treatment
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.
Dayton VA Medical Center is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients with clinically stable severe COPD will be randomized. Each group will participate in 3 drug study sessions separated by 7-14 days. Arm label "Intranasal-Dexmedetomidine (IN-DEX) intranasal 1.0 mcg/kg" will participate in 3 drug study sessions separated by 7-14 days. All drug study sessions will be conducted in a monitored acute care setting with medical staff in attendance. Sedation assessment and vital signs will be recorded at 15 minute and 5-15 minute intervals respectively, for a minimum of 3 hours.
Drug: IN-DEX 1.0 mcg/kg, intranasal saline
Patients with clinically stable severe COPD will be randomized. Each group will participate in 3 drug study sessions separated by 7-14 days. Arm label "IN-DEX intranasal 1.5 mcg/kg" will participate in 3 drug study sessions separated by 7-14 days. All drug study sessions will be conducted in a monitored acute care setting with medical staff in attendance. Sedation assessment and vital signs will be recorded at 15 minute and 5-15 minute intervals respectively, for a minimum of 3 hours.
Drug: IN-DEX 1.5 mcg/kg, intranasal saline
Patients with clinically stable severe COPD will be randomized. Each group will participate in 3 drug study sessions separated by 7-14 days. Arm label "Placebo - Saline" will participate in 3 drug study sessions separated by 7-14 days. All drug study sessions will be conducted in a monitored acute care setting with medical staff in attendance. Sedation assessment and vital signs will be recorded at 15 minute and 5-15 minute intervals respectively, for a minimum of 3 hours.
Drug: Placebo - Saline
Also known as: precedex
Also known as: precedex
Modified Observer's Assessment of Alertness/Sedation Scale
Time frame: every 15 minutes up to 5 hours after intranasal dexmedetomidine
Sedation Visual Analog Scale (VAS)
Time frame: Every 15 minutes up to 5 hours after intranasal dexmedetomidine
Changes in Vital Signs
heart rate, noninvasive blood pressure, respiratory rate, continuous pulse oximetry
Time frame: Every 5 minutes for 90 minutes, then every 15 minutes for up to 5 hours
This study is withdrawn, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Dayton VA Medical Center