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

COPD Clinical Trial

Official title:

Sedation and Physiologic Response to Intranasal Dexmedetomidine in Severe Chronic Obstructive Pulmonary Disease (COPD): A Randomized, Blinded, Placebo Controlled Crossover Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02773797
• Other study ID #: Nystrom02
• Status: Withdrawn
• Phase: Phase 4
• Start date: August 2016
• Est. completion date: April 2018

Study information

• Verified date: July 2018
• Source: Dayton VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• IN-DEX 1.0 mcg/kg, intranasal saline

• IN-DEX 1.5 mcg/kg, intranasal saline

• Placebo - Saline

Locations

Country	Name	City	State
United States	Dayton VA Medical Center	Dayton	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Dayton VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Observer's Assessment of Alertness/Sedation Scale		every 15 minutes up to 5 hours after intranasal dexmedetomidine
Primary	Sedation Visual Analog Scale (VAS)		Every 15 minutes up to 5 hours after intranasal dexmedetomidine
Primary	Changes in Vital Signs	heart rate, noninvasive blood pressure, respiratory rate, continuous pulse oximetry	Every 5 minutes for 90 minutes, then every 15 minutes for up to 5 hours