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Placebo Controlled Evaluation of Sedation and Physiological Response to Intranasal Dexmedetomidine in Severe COPD

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ClinicalTrials.gov Identifier: NCT02773797
Recruitment Status : Withdrawn
First Posted : May 16, 2016
Last Update Posted : July 31, 2018
Sponsor:
Information provided by (Responsible Party):
Dayton VA Medical Center

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
COPD Drug: IN-DEX 1.0 mcg/kg, intranasal saline Drug: IN-DEX 1.5 mcg/kg, intranasal saline Drug: Placebo - Saline Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Sedation and Physiologic Response to Intranasal Dexmedetomidine in Severe Chronic Obstructive Pulmonary Disease (COPD): A Randomized, Blinded, Placebo Controlled Crossover Trial
Study Start Date : August 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : April 2018

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Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: 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 "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
Other Name: precedex
Placebo Comparator: 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 "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
Other Name: precedex
Active Comparator: Placebo - 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


Outcome Measures
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Primary Outcome Measures :
  1. Modified Observer's Assessment of Alertness/Sedation Scale [ Time Frame: every 15 minutes up to 5 hours after intranasal dexmedetomidine ]
  2. Sedation Visual Analog Scale (VAS) [ Time Frame: Every 15 minutes up to 5 hours after intranasal dexmedetomidine ]
  3. Changes in Vital Signs [ Time Frame: Every 5 minutes for 90 minutes, then every 15 minutes for up to 5 hours ]
    heart rate, noninvasive blood pressure, respiratory rate, continuous pulse oximetry


Eligibility Criteria
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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Severe COPD (FEV1 < 50% predicted)
  • Age 45-70
  • American Society of Anesthesiologists (ASA) Class 3
  • Body Mass Index < 35 kg/meter squared
  • No prior history of adverse reactions to alpha 2 agonists (dexmedetomidine, clonidine)

Exclusion Criteria:

  • known adverse reaction, allergy or hypersensitivity, to alpha 2 agonists
  • Not nothing by mouth (NPO)
  • ASA class >3
  • Home oxygen therapy >2LPM by nasal cannula continuous use
  • Any evidence of nasal mucosal inflammation, irritation, bleeding or ulceration
  • Pregnancy, or possibility of pregnancy
  • Coronary heart disease with stable or unstable angina
  • Baseline heart rate <55 beats per minute
  • Bradyarrhythmia, heart block, presence of pacemaker
  • Congestive Heart Failure or known Cardiomyopathy (Ejection Fraction <40% by ECHO, MUGA, or myocardial perfusion imaging)
  • Cor pulmonale
  • Liver disease (hepatic transaminases > 2x upper limit of normal, cirrhosis, end stage liver disease)
  • diagnosis of moderate to severe Obstructive Sleep Apnea
  • currently enrolled in any other research study involving drugs or devices
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02773797


Locations
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United States, Ohio
Dayton VA Medical Center
Dayton, Ohio, United States, 45428
Sponsors and Collaborators
Dayton VA Medical Center
More Information
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Responsible Party: Dayton VA Medical Center
ClinicalTrials.gov Identifier: NCT02773797    
Other Study ID Numbers: Nystrom02
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: July 2018
Keywords provided by Dayton VA Medical Center:
Sedation
Dexmedetomidine
Additional relevant MeSH terms:
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Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action