HealthyPhase 1NCT01050933
Safety Study of Inhaling Carbon Monoxide in Healthy Volunteers
A Phase 1 study testing 250 ppm carbon monoxide in people with Healthy, run by Queen's University at 1 site in Canada.
Trial summary
Post operative ileus (POI), a temporary paralysis of the intestines, is a serious health care problem. It normally occurs in all patients after surgery to the abdomen but in some cases can result in serious complications. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 250 ppm carbon monoxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2010to Oct 2011
- Phase
- Phase 1
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women, age > 18 years.
- Women must be using acceptable contraceptives, post-menopausal or surgically sterile.
- No prior smoking history.
- BMI between 16 and 30 inclusive.
- In good health as per medical history, physical exam, vital signs \& ECG.
Who cannot join
- Exposure to carbon monoxide during the 48 hours prior to the study day.
- Occupational exposure to CO.
- Significant disease that may put the volunteer at risk because of participation in the study or may influence the results of the study or the volunteer's ability to participate in the study.
- Baseline blood level of COHb >2%.
- Patients with underlying lung disease such as asthma or COPD.
- Baseline oxygen saturation <92% on room air.
- Planned pregnancy, already pregnant or breastfeeding.
- Participation in another clinical trial within 2 months prior to study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Tolerability of Inhaled Carbon Monoxide in Healthy Volunteers
Post operative ileus (POI), a temporary paralysis of the intestines, is a serious health care problem. It normally occurs in all patients after surgery to the abdomen but in some cases can result in serious complications. The objective of this study is to determine if inhaling very low doses of carbon monoxide (CO) before and after colon surgery will shorten the duration of normal POI and/or prevent the development of POI complications in patients undergoing colon surgery.
This preliminary study will be conducted in ten healthy volunteers to monitor for blood levels and adverse effects that occur at different durations of exposure of inhaled CO to establish a safe dose for patients in the main trial. For the main trial, patients requiring surgery to their colon will be assigned randomly to receive one hour treatments of either CO or oxygen by face mask before and after their operation.
We hypothesize that healthy volunteers will be able to tolerate 1 hour doses of 250 ppm of CO with minimal side effects. It is also anticipated that for each dose of CO administered, the blood levels of CO will remain well under poisonous levels. Finally, we anticipate blood levels of CO will return to baseline level within 24 hours following the last dose of CO.
- Conditions
- Healthy
- Being tested
- 250 ppm carbon monoxide
- Keywords
- Healthy volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
250 ppm carbon monoxideDrug
250 ppm of inhaled carbon monoxide over one hour
| Study group | Role | What they receive |
|---|---|---|
| Carbon Monoxide | Experimental | Healthy volunteers will receive 250 ppm of carbon monoxide by face mask. This dose will be administered for 1 hour with continuous COHb monitoring. At baseline and at each half hour time point, a blood sample will be drawn to be analyzed by the gas chromatograph. After 1 hour, the volunteer will be excused and asked to return in 4 hours and this procedure repeated. At any point, if the COHb level reaches 10%, administration of CO will be terminated. Receives: Drug: 250 ppm carbon monoxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event Rate
Measured: Before and after carbon monoxide exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2010 (estimated)
- Study startSep 2010
- Primary completionJun 2011
- Study completionOct 2011
Why it stopped: resident left and no one to take over
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Responsible party
- Principal investigator, Dr. Paul Belliveau, Queen's University
- Investigators
- Paul Belliveau, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01050933
- Sponsor's protocol ID
- POICO-A
- Status last verified
- Nov 2015
- First submitted
- 13 Jan 2010
- Last updated
- 17 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability of Inhaled Carbon Monoxide in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01050933
- Acronym / sponsor ID
- POICO-A
- Conditions
- Healthy
- Keywords
- Healthy volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: resident left and no one to take over
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- Sep 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 18 Jan 2010 (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.
Post operative ileus (POI), a temporary paralysis of the intestines, is a serious health care problem. It normally occurs in all patients after surgery to the abdomen but in some cases can result in serious complications. The objective of this study is to determine if inhaling very low doses of carbon monoxide (CO) before and after colon surgery will shorten the duration of normal POI and/or prevent the development of POI complications in patients undergoing colon surgery.
This preliminary study will be conducted in ten healthy volunteers to monitor for blood levels and adverse effects that occur at different durations of exposure of inhaled CO to establish a safe dose for patients in the main trial. For the main trial, patients requiring surgery to their colon will be assigned randomly to receive one hour treatments of either CO or oxygen by face mask before and after their operation.
We hypothesize that healthy volunteers will be able to tolerate 1 hour doses of 250 ppm of CO with minimal side effects. It is also anticipated that for each dose of CO administered, the blood levels of CO will remain well under poisonous levels. Finally, we anticipate blood levels of CO will return to baseline level within 24 hours following the last dose of CO.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carbon Monoxide | Experimental | Drug: 250 ppm carbon monoxideHealthy volunteers will receive 250 ppm of carbon monoxide by face mask. This dose will be administered for 1 hour with continuous COHb monitoring. At baseline and at each half hour time point, a blood sample will be drawn to be analyzed by the gas chromatograph. After 1 hour, the volunteer will be excused and asked to return in 4 hours and this procedure repeated. At any point, if the COHb level reaches 10%, administration of CO will be terminated. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women, age > 18 years.
- Women must be using acceptable contraceptives, post-menopausal or surgically sterile.
- No prior smoking history.
- BMI between 16 and 30 inclusive.
- In good health as per medical history, physical exam, vital signs \& ECG.
Key exclusion criteria (8 listed)
- Exposure to carbon monoxide during the 48 hours prior to the study day.
- Occupational exposure to CO.
- Significant disease that may put the volunteer at risk because of participation in the study or may influence the results of the study or the volunteer's ability to participate in the study.
- Baseline blood level of COHb >2%.
- Patients with underlying lung disease such as asthma or COPD.
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 |
|---|---|---|
| 250 ppm carbon monoxide250 ppm of inhaled carbon monoxide over one hour | Drug | Carbon Monoxide |
Primary outcome
Adverse Event Rate
Time frame: Before and after carbon monoxide exposure
Results and safety
The study was stopped early (reason given: resident left and no one to take over). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2015.
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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.
Paul Belliveau, MD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 250 ppm carbon monoxide in people with Healthy, run by Queen's University at 1 site in Canada.
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 8 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 17 Nov 2015. 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 Canada. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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: resident left and no one to take over). 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?
Adverse Event Rate (time frame: Before and after carbon monoxide exposure). 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 17 Nov 2015.