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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Recruitment Status : Withdrawn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

Tracking Information
First Submitted Date  ICMJE May 9, 2016
First Posted Date  ICMJE May 16, 2016
Last Update Posted Date July 31, 2018
Study Start Date  ICMJE August 2016
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2016)
  • 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 [ 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Placebo Controlled Evaluation of Sedation and Physiological Response to Intranasal Dexmedetomidine in Severe COPD
Official Title  ICMJE Sedation and Physiologic Response to Intranasal Dexmedetomidine in Severe Chronic Obstructive Pulmonary Disease (COPD): A Randomized, Blinded, Placebo Controlled Crossover Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE COPD
Intervention  ICMJE
  • Drug: IN-DEX 1.0 mcg/kg, intranasal saline
    Other Name: precedex
  • Drug: IN-DEX 1.5 mcg/kg, intranasal saline
    Other Name: precedex
  • Drug: Placebo - Saline
Study Arms  ICMJE
  • 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.
    Intervention: Drug: IN-DEX 1.0 mcg/kg, intranasal saline
  • 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.
    Intervention: Drug: IN-DEX 1.5 mcg/kg, intranasal saline
  • 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.
    Intervention: Drug: Placebo - Saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: July 30, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: May 13, 2016)
50
Estimated Study Completion Date  ICMJE April 2018
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02773797
Other Study ID Numbers  ICMJE Nystrom02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dayton VA Medical Center
Study Sponsor  ICMJE Dayton VA Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Dayton VA Medical Center
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP