COPDPhase 4NCT02211118
Sedation and Physiological Effects of Intranasal Dexmedetomidine in Severe COPD
A Phase 4 study testing Intranasal dexemdetomidine (IN-DEX) in people with COPD and Sedation, run by Dayton VA Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- COPD, Sedation, Dexmedetomidine
- What is being tested?
- Intranasal dexemdetomidine (IN-DEX)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Apr 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Intranasal dexemdetomidine (IN-DEX)
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal dexemdetomidine (IN-DEX)Drug
Also called precedex
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Intranasal dexemdetomidine (IN-DEX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Observer's Assessment of Alertness/Sedation Scale
Measured: every 15 minutes up to 5 hours after intranasal desmedetomidine
Sedation Visual Analog Scale (VAS)
Measured: Every 15 minutes up to 5 hours after intranasal dexemdetomidine
Changes in Vital Signs
Heart rate, noninvasive blood pressure, respitory rate, pulse oximetry
Measured: Every 5 minutes for 90 minutes, then every 15 minutes for up to 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dayton VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02211118
- Sponsor's protocol ID
- Nystrom01
- Status last verified
- Jul 2019
- First submitted
- 4 Aug 2014
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sedation and Physiological Effects of Intranasal Dexmedetomidine in Severe COPD
- ClinicalTrials.gov ID
- NCT02211118
- Acronym / sponsor ID
- Nystrom01
- Conditions
- COPD, Sedation, Dexmedetomidine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dayton VA Medical CenterUS federal agency
- Study start
- Oct 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 7 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IN-DEX | Experimental | Drug: Intranasal dexemdetomidine (IN-DEX)Subjects will be administered 1 mcg/kg or 1.5 mcg/kg intranasal dexemdetomidine (IN-DEX) and monitored for up to 5 hours. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intranasal dexemdetomidine (IN-DEX)Also: precedex | Drug | IN-DEX |
Primary outcome
Modified Observer's Assessment of Alertness/Sedation Scale
Time frame: every 15 minutes up to 5 hours after intranasal desmedetomidine
Sedation Visual Analog Scale (VAS)
Time frame: Every 15 minutes up to 5 hours after intranasal dexemdetomidine
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, respitory rate, pulse oximetry
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intranasal dexemdetomidine (IN-DEX) in people with COPD and Sedation, run by Dayton VA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Observer's Assessment of Alertness/Sedation Scale (time frame: every 15 minutes up to 5 hours after intranasal desmedetomidine). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2019.