COPD ExacerbationPhase 4NCT04420455
The Effects of Enoximone in Acute Exacerbation COPD
A Phase 4 study testing Enoximone in people with COPD Exacerbation and Enoximone, run by Rijnstate Hospital at 1 site in Netherlands.
Trial summary
Introduction: The pharmacodynamic properties of enoximone could be beneficial for patients with an Acute Exacerbation COPD (AE-COPD). This research will focus on patients suffering of a severe AE-COPD and the bronchodilatory and inotropic effects of lower doses of enoximone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD Exacerbation, Enoximone, Phosphodiesterase Inhibitor
- What is being tested?
- Enoximone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 May 2020to 21 Dec 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with an AE-COPD for which intubation occurred within 24 hours before enrolment.
Who cannot join
- Patients with known asthma or interstitial lung disease (ILD)
- Known neurodegenerative diseases such as Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Guillain-Barre and Dementia
- Hypertrophic obstructive cardiomyopathy (HOCM)
- Severe aortic stenosis with aortic valve area < 1cm2
- Known ventricular arrhythmias
- Severe kidney disorders with Glomerular Filtration Rate (GFR) < 30
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- Severe liver insufficiency with spontaneous PT/INR > 1.5
- Pregnancy
- Lactation
- High dose-diuretics use (daily dose of >480 mg furosemide)
Trial locations and contacts
1 site in 1 country.
About this study
Introduction:
The pharmacodynamic properties of enoximone could be beneficial for patients with an Acute Exacerbation COPD (AE-COPD). This research will focus on patients suffering of a severe AE-COPD and the bronchodilatory and inotropic effects of lower doses of enoximone. The main objective of the pilot study is to investigate if there is a bronchodilatory effect of enoximone in patients with AE-COPD. Secondary objective is to investigate a dose responsiveness in a range between 0.5 and 1.5 mg/kg enoximone.
Read more
Methods:
The study design is a prospective interventional non-randomized clinical series study involving patients admitted and intubated at the Intensive Care Unit (ICU) with an AE-COPD. Patients will receive three times a dose of 0.5 mg/kg enoximone with a one-hour-interval. The primary objective is a reduction in auto-positive end-expiratory pressure (PEEP) after enoximone compared to baseline. A dose-titration will test for dose dependency. Secondary objectives are a reduction in ventilator pressures, a reduction in pulmonary artery pressures and an increase in cardiac output.
Read the detailed description
Ventilator will be set during the study period at Volume Controle, 6 ml/kg, 5 PEEP and a respiratory rate of 15 bpm with an I:E-ratio of 1:2.
Salbutamol/ipratropium bromide and magnesium sulphate will be administered at baseline (t=0h) and measurements will be made for an hour.
At T=1h the first dose of 0.5 mg/kg enoximone will be administered and will be repeated at T=2h and T=3h. Ventilator derived variables will be obtained every fifteen minutes and echocardiography, arterial and central venous bloodgas analyses every hour until t=6h.
- Conditions
- COPD Exacerbation, Enoximone, Phosphodiesterase Inhibitor
- Being tested
- Enoximone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnoximoneDrug
Patients will receive three times a dose of 0.5 mg/kg enoximone with a one-hour-interval.
| Study group | Role | What they receive |
|---|---|---|
| Enoximone | Experimental | Patients will receive three times a dose of 0.5 mg/kg enoximone with a one-hour-interval. Receives: Drug: Enoximone |
What is being measured
The primary outcome is the main question the study is designed to answer.
PEEP
Reduction in intrinsic PEEP, in cmH2O
Measured: within 6 hoursmeasured every 15 minutes
Secondary outcomes (14)
Lung compliance
ml/H2O
Measured: within 6 hours, measured every hour
Airway resistence
cmH2O/L/sec
Measured: within 6 hours, measured every hour
VEI
ml
Measured: within 6 hours, measured every hour
VCO2
ml/min
Measured: within 6 hours, measured every hour
etCO2
kPa
Measured: within 6 hours, measured every hour
Vd/Vt
Measured by Bohr-equation, in percentage
Measured: within 6 hours, measured every hour
FiO2
percentage
Measured: within 6 hours, measured every hour
Shunt fraction
measured by Fick-equation, using the SvO2, in percentage
Measured: within 6 hours, measured every hour
Cardiac Output
Measured by echocardiography (LVOT VTI), ml/hr
Measured: within 6 hours, measured every hour
RVSP
Measured by echocardiography, in mmHg
Measured: within 6 hours, measured every hour
TAPSE
Measured by echocardiography, in mm
Measured: within 6 hours, measured every hour
MAPSE
Measured by echocardiography, in mm
Measured: within 6 hours, measured every hour
LV Ejection Fraction
Measured by echocardiography, in percentage
Measured: within 6 hours, measured every hour
Bloodgas analysis
Arterial bloodgas analysis and central venous gas analysis (through catheter placed in superior vena cava)
Measured: within 6 hours, measured every hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start12 May 2020
- Primary completion21 Dec 2021
- Study completion21 Dec 2021
Why it stopped: A limited number of inclusions due to the Covid-pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD ExacerbationStudies 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04420455
- Sponsor's protocol ID
- 2019-1432
- Status last verified
- Dec 2021
- First submitted
- 31 Jan 2020
- Last updated
- 13 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Enoximone in Acute Exacerbation COPD
- ClinicalTrials.gov ID
- NCT04420455
- Acronym / sponsor ID
- 2019-1432
- Conditions
- COPD Exacerbation, Enoximone, Phosphodiesterase Inhibitor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: A limited number of inclusions due to the Covid-pandemic
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- 12 May 2020 (actual)
- Primary completion
- 21 Dec 2021 (actual)
- Study completion
- 21 Dec 2021 (actual)
- First posted
- 9 Jun 2020 (actual)
- 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.
Introduction:
The pharmacodynamic properties of enoximone could be beneficial for patients with an Acute Exacerbation COPD (AE-COPD). This research will focus on patients suffering of a severe AE-COPD and the bronchodilatory and inotropic effects of lower doses of enoximone. The main objective of the pilot study is to investigate if there is a bronchodilatory effect of enoximone in patients with AE-COPD. Secondary objective is to investigate a dose responsiveness in a range between 0.5 and 1.5 mg/kg enoximone.
Methods:
The study design is a prospective interventional non-randomized clinical series study involving patients admitted and intubated at the Intensive Care Unit (ICU) with an AE-COPD. Patients will receive three times a dose of 0.5 mg/kg enoximone with a one-hour-interval. The primary objective is a reduction in auto-positive end-expiratory pressure (PEEP) after enoximone compared to baseline. A dose-titration will test for dose dependency. Secondary objectives are a reduction in ventilator pressures, a reduction in pulmonary artery pressures and an increase in cardiac output.
Detailed description
Ventilator will be set during the study period at Volume Controle, 6 ml/kg, 5 PEEP and a respiratory rate of 15 bpm with an I:E-ratio of 1:2.
Salbutamol/ipratropium bromide and magnesium sulphate will be administered at baseline (t=0h) and measurements will be made for an hour.
At T=1h the first dose of 0.5 mg/kg enoximone will be administered and will be repeated at T=2h and T=3h. Ventilator derived variables will be obtained every fifteen minutes and echocardiography, arterial and central venous bloodgas analyses every hour until t=6h.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enoximone | Experimental | Drug: EnoximonePatients will receive three times a dose of 0.5 mg/kg enoximone with a one-hour-interval. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with an AE-COPD for which intubation occurred within 24 hours before enrolment.
Key exclusion criteria (10 listed)
- Patients with known asthma or interstitial lung disease (ILD)
- Known neurodegenerative diseases such as Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Guillain-Barre and Dementia
- Hypertrophic obstructive cardiomyopathy (HOCM)
- Severe aortic stenosis with aortic valve area < 1cm2
- Known ventricular arrhythmias
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 |
|---|---|---|
| EnoximonePatients will receive three times a dose of 0.5 mg/kg enoximone with a one-hour-interval. | Drug | Enoximone |
Primary outcome
PEEP
Time frame: within 6 hoursmeasured every 15 minutes
Reduction in intrinsic PEEP, in cmH2O
14 secondary outcomes
Lung compliance
Time frame: within 6 hours, measured every hour
Airway resistence
Time frame: within 6 hours, measured every hour
VEI
Time frame: within 6 hours, measured every hour
VCO2
Time frame: within 6 hours, measured every hour
etCO2
Time frame: within 6 hours, measured every hour
Vd/Vt
Time frame: within 6 hours, measured every hour
FiO2
Time frame: within 6 hours, measured every hour
Shunt fraction
Time frame: within 6 hours, measured every hour
Cardiac Output
Time frame: within 6 hours, measured every hour
RVSP
Time frame: within 6 hours, measured every hour
TAPSE
Time frame: within 6 hours, measured every hour
MAPSE
Time frame: within 6 hours, measured every hour
LV Ejection Fraction
Time frame: within 6 hours, measured every hour
Bloodgas analysis
Time frame: within 6 hours, measured every hour
Results and safety
The study was stopped early (reason given: A limited number of inclusions due to the Covid-pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- Individual participant dataSharing planned: Yes
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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 Enoximone in people with COPD Exacerbation and Enoximone, run by Rijnstate Hospital at 1 site in Netherlands.
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 1 inclusion and 10 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: stopped early, as of the sponsor's last update on 13 Jan 2022. 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 Netherlands. 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 was stopped early (reason given: A limited number of inclusions due to the Covid-pandemic). Results are not available in the source record.
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?
PEEP (time frame: within 6 hoursmeasured every 15 minutes). 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 13 Jan 2022.