COPDPhase 4NCT02773797
Placebo Controlled Evaluation of Sedation and Physiological Response to Intranasal Dexmedetomidine in Severe COPD
A Phase 4 study testing IN-DEX 1.0 mcg/kg, intranasal saline and IN-DEX 1.5 mcg/kg, intranasal saline in people with COPD, 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
- What is being tested?
- IN-DEX 1.0 mcg/kg, intranasal saline and IN-DEX 1.5 mcg/kg, intranasal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Apr 2018
- 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 < 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)
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 > 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sedation and Physiologic Response to Intranasal Dexmedetomidine in Severe Chronic Obstructive Pulmonary Disease (COPD): A Randomized, Blinded, Placebo Controlled Crossover Trial
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.
Read more
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.
- Conditions
- COPD
- Being tested
- IN-DEX 1.0 mcg/kg, intranasal saline, IN-DEX 1.5 mcg/kg, intranasal saline, Placebo - Saline
- Keywords
- Sedation, Dexmedetomidine
- 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.
IN-DEX 1.0 mcg/kg, intranasal salineDrug
Also called precedex
IN-DEX 1.5 mcg/kg, intranasal salineDrug
Also called precedex
Placebo - SalineDrug
| Study group | Role | What they receive |
|---|---|---|
| IN-DEX 1.0 mcg/kg, intranasal saline | Placebo comparator | 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. Receives: Drug: IN-DEX 1.0 mcg/kg, intranasal saline |
| IN-DEX, 1.5 mcg/kg intranasal saline | Placebo comparator | 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. Receives: Drug: IN-DEX 1.5 mcg/kg, intranasal saline |
| Placebo - Saline | Active comparator | 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. Receives: Drug: Placebo - Saline |
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 dexmedetomidine
Sedation Visual Analog Scale (VAS)
Measured: Every 15 minutes up to 5 hours after intranasal dexmedetomidine
Changes in Vital Signs
heart rate, noninvasive blood pressure, respiratory rate, continuous 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 posted16 May 2016 (estimated)
- Study startAug 2016
- Primary completionJul 2017 (estimated)
- Study completionApr 2018 (estimated)
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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 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
- NCT02773797
- Sponsor's protocol ID
- Nystrom02
- Status last verified
- Jul 2018
- First submitted
- 9 May 2016
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sedation and Physiologic Response to Intranasal Dexmedetomidine in Severe Chronic Obstructive Pulmonary Disease (COPD): A Randomized, Blinded, Placebo Controlled Crossover Trial
- ClinicalTrials.gov ID
- NCT02773797
- Acronym / sponsor ID
- Nystrom02
- Conditions
- COPD
- Keywords
- Sedation, Dexmedetomidine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dayton VA Medical CenterUS federal agency
- Study start
- Aug 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 16 May 2016 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IN-DEX 1.0 mcg/kg, intranasal saline | Placebo comparator | Drug: IN-DEX 1.0 mcg/kg, intranasal salinePatients 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. |
| IN-DEX, 1.5 mcg/kg intranasal saline | Placebo comparator | Drug: IN-DEX 1.5 mcg/kg, intranasal salinePatients 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. |
| Placebo - Saline | Active comparator | Drug: Placebo - SalinePatients 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. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
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 |
|---|---|---|
| IN-DEX 1.0 mcg/kg, intranasal salineAlso: precedex | Drug | IN-DEX 1.0 mcg/kg, intranasal saline |
| IN-DEX 1.5 mcg/kg, intranasal salineAlso: precedex | Drug | IN-DEX, 1.5 mcg/kg intranasal saline |
| Placebo - Saline | Drug | Placebo - Saline |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
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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 IN-DEX 1.0 mcg/kg, intranasal saline and IN-DEX 1.5 mcg/kg, intranasal saline in people with COPD, 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 5 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: withdrawn, as of the sponsor's last update on 31 Jul 2018. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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 dexmedetomidine). 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 31 Jul 2018.