HypoxiaEarly Phase 1NCT04870801
An Alternative Way To Deliver Oxygen To People
A Early Phase 1 study testing Respirogen Micro-Oxygen in people with Hypoxia, run by Christopher Bell at 1 site in United States.
Trial summary
The availability of oxygen is a crucial prognostic indicator for outcomes pertinent to many chronic diseases. Accordingly, interventions that might increase oxygen availability have obvious beneficial clinical application. In this regard, Respirogen Micro-Oxygen (RMO) technology holds considerable promise. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoxia
- What is being tested?
- Respirogen Micro-Oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2022to Jan 2024
- Phase
- Early 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age between 18-40 years,
- body mass index between 19 and 30 kg/m^2,
- resident at a similar altitude for a minimum of 1-year,
- no travel to/from areas varying by ~2000 feet of elevation within 4-weeks of initiation of study participation.
Who cannot join
- identification of overt chronic disease (including cardio-pulmonary disorders),
- prior diagnosis of asthma, cystic fibrosis, Chronic obstructive pulmonary disease, or ventilator therapy
- anemia,
- pregnancy,
- habitual use of tobacco/nicotine products,
- known allergy to sodium phosphate (or other common laxatives),
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- habitual use of recreational drugs that require inhalation,
- history of seizures, kidney problems, stomach or bowel problems, ulcerative colitis, problems with swallowing or gastric reflux, gout, and and/or low blood sodium.
- irritable bowel
- ACUTE respiratory illness such as bronchitis, pneumonia, Upper Respiratory Infection OR ACUTE GI issues such as gastroenteritis.
- Anemia (as measurement of hemoglobin and/or hematocrit) .
- sickle cell disease.
- history of altitude sickness
Trial locations and contacts
1 site in 1 country.
United States1 site
Colorado State University, Dept. of Health and Exercise Science
Fort Collins, Colorado, 80523-1582
About this study
Official title: Evaluation of Respirogen Oxygen Microbubble Technology: Efficacy for Human Use During Rest in Normal and Low-oxygen Environments
The availability of oxygen is a crucial prognostic indicator for outcomes pertinent to many chronic diseases. Accordingly, interventions that might increase oxygen availability have obvious beneficial clinical application. In this regard, Respirogen Micro-Oxygen (RMO) technology holds considerable promise. Data from experimental animal models of lung injury suggest administration of RMO is a feasible method to deliver oxygen in a manner independent of pulmonary function. Our ultimate long-term goal is to provide a product that can be used to deliver oxygen to humans experiencing respiratory distress and pulmonary dysfunction In this first exploratory study, our goal is to begin to understand the physiological responses to enteral (rectal) delivery of RMO in low-oxygen environments in healthy adults at rest.
- Conditions
- Hypoxia
- Being tested
- Respirogen Micro-Oxygen
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respirogen Micro-OxygenDrug
Enteral (rectal) delivery of Respirogen Micro-Oxygen
| Study group | Role | What they receive |
|---|---|---|
| Low Oxygen Visits without Respirogen Micro-Oxygen | No intervention | During each visit, study participants will undergo physiological monitoring prior to and during inhalation of hypoxic (FiO2=0.15) gas mixtures. |
| Low Oxygen Visits with Respirogen Micro-Oxygen | Experimental | During each visit, study participants will undergo physiological monitoring prior to and during inhalation of hypoxic (FiO2=0.15) gas mixtures. Receives: Drug: Respirogen Micro-Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increases Oxygen saturation (SpO2) with RMO
Enteral (rectal) delivery of without and with RMO to resting adult men and women during short-term breathing of hypoxic gas mixtures.
Measured: Randomized crossover, visits separated by a minimum 7 days and maxim 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study startJan 2022 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionJan 2024 (estimated)
Why it stopped: The project was denied funding and the protocol was subsequently closed. No participants were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies 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
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Following screening, six healthy adults will report to the Human Performance Clinical Research Laboratory on two separate occasions, each separated by \~7-14 days. During each visit, study participants will undergo physiological monitoring prior to and during inhalation of hypoxic (FiO2=0.15) gas mixtures. During one of these visits, following initiation of hypoxic gas breathing, colon administration of RMO will commence.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christopher Bell
- Sponsor type
- University, hospital or other
- Collaborators
- Respirogen Inc.
- Responsible party
- Sponsor-investigator, Christopher Bell, Colorado State University
- Investigators
- Chris Bell, PhD, Principal investigator, CSU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04870801
- Sponsor's protocol ID
- 20-10219H
- Status last verified
- Jun 2022
- First submitted
- 29 Apr 2021
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Respirogen Oxygen Microbubble Technology: Efficacy for Human Use During Rest in Normal and Low-oxygen Environments
- ClinicalTrials.gov ID
- NCT04870801
- Acronym / sponsor ID
- 20-10219H
- Conditions
- Hypoxia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The project was denied funding and the protocol was subsequently closed. No participants were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Christopher BellUniversity, hospital or other
- Collaborators
- Respirogen Inc.
- Study start
- Jan 2022 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 4 May 2021 (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.
The availability of oxygen is a crucial prognostic indicator for outcomes pertinent to many chronic diseases. Accordingly, interventions that might increase oxygen availability have obvious beneficial clinical application. In this regard, Respirogen Micro-Oxygen (RMO) technology holds considerable promise. Data from experimental animal models of lung injury suggest administration of RMO is a feasible method to deliver oxygen in a manner independent of pulmonary function. Our ultimate long-term goal is to provide a product that can be used to deliver oxygen to humans experiencing respiratory distress and pulmonary dysfunction In this first exploratory study, our goal is to begin to understand the physiological responses to enteral (rectal) delivery of RMO in low-oxygen environments in healthy adults at rest.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Following screening, six healthy adults will report to the Human Performance Clinical Research Laboratory on two separate occasions, each separated by ~7-14 days. During each visit, study participants will undergo physiological monitoring prior to and during inhalation of hypoxic (FiO2=0.15) gas mixtures. During one of these visits, following initiation of hypoxic gas breathing, colon administration of RMO will commence.
| Arm | Type | Receives |
|---|---|---|
| Low Oxygen Visits without Respirogen Micro-Oxygen | No intervention | –During each visit, study participants will undergo physiological monitoring prior to and during inhalation of hypoxic (FiO2=0.15) gas mixtures. |
| Low Oxygen Visits with Respirogen Micro-Oxygen | Experimental | Drug: Respirogen Micro-OxygenDuring each visit, study participants will undergo physiological monitoring prior to and during inhalation of hypoxic (FiO2=0.15) gas mixtures. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age between 18-40 years,
- body mass index between 19 and 30 kg/m^2,
- resident at a similar altitude for a minimum of 1-year,
- no travel to/from areas varying by ~2000 feet of elevation within 4-weeks of initiation of study participation.
Key exclusion criteria (13 listed)
- identification of overt chronic disease (including cardio-pulmonary disorders),
- prior diagnosis of asthma, cystic fibrosis, Chronic obstructive pulmonary disease, or ventilator therapy
- anemia,
- pregnancy,
- habitual use of tobacco/nicotine products,
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 |
|---|---|---|
| Respirogen Micro-OxygenEnteral (rectal) delivery of Respirogen Micro-Oxygen | Drug | Low Oxygen Visits with Respirogen Micro-Oxygen |
Primary outcome
Increases Oxygen saturation (SpO2) with RMO
Time frame: Randomized crossover, visits separated by a minimum 7 days and maxim 14 days
Enteral (rectal) delivery of without and with RMO to resting adult men and women during short-term breathing of hypoxic gas mixtures.
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 30 Jun 2022.
- Individual participant dataSharing planned: No
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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.
Chris Bell, PhD principal investigator
CSU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Respirogen Micro-Oxygen in people with Hypoxia, run by Christopher Bell 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 4 inclusion and 13 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 30 Jun 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 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Increases Oxygen saturation (SpO2) with RMO (time frame: Randomized crossover, visits separated by a minimum 7 days and maxim 14 days). 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 30 Jun 2022.