Sedation and Physiological Effects of Intranasal Dexmedetomidine in Severe COPD

NCT02211118 | Completed Phase 4 DMC

• 1 other identifier: Nystrom01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 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.

Conditions

COPD; Sedation; Dexmedetomidine

Outcome Measures

Primary Outcomes (3)

• Modified Observer's Assessment of Alertness/Sedation Scale

  every 15 minutes up to 5 hours after intranasal desmedetomidine

• Sedation Visual Analog Scale (VAS)

  Every 15 minutes up to 5 hours after intranasal dexemdetomidine

• Changes in Vital Signs

  Heart rate, noninvasive blood pressure, respitory rate, pulse oximetry

  Every 5 minutes for 90 minutes, then every 15 minutes for up to 5 hours

Study Arms (1)

IN-DEX

EXPERIMENTAL

Subjects will be administered 1 mcg/kg or 1.5 mcg/kg intranasal dexemdetomidine (IN-DEX) and monitored for up to 5 hours.

Drug: Intranasal dexemdetomidine (IN-DEX)

Interventions

Intranasal dexemdetomidine (IN-DEX) DRUG

Also known as: precedex

IN-DEX

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe COPD (FEV1 30-50% 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)
• Women of non-child bearing age

You may not qualify if:

• 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 above the 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

Sponsors & Collaborators

• Dayton VA Medical Center: lead

Study Sites (1)

Dayton VA Medical Center

Dayton, Ohio, 45428, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2014
• First Posted: August 7, 2014
• Study Start: October 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: April 1, 2016
• Last Updated: July 18, 2019

Record last verified: 2019-07

Locations

US (1)