Clinical trial NCT04870801: An Alternative Way To Deliver Oxygen To People
Official title: Evaluation of Respirogen Oxygen Microbubble Technology: Efficacy for Human Use During Rest in Normal and Low-oxygen Environments
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Hypoxia
Lead sponsor: Colorado State University
Sponsor class: OTHER
Collaborators: name: Respirogen Inc.
First posted: 2021-05-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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),
* 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

Primary outcomes:
measure: Increases Oxygen saturation (SpO2) with RMO
timeFrame: Randomized crossover, visits separated by a minimum 7 days and maxim 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Collins
country: United States
facility: Colorado State University, Dept. of Health and Exercise Science
state: Colorado
Study officials:
affiliation: CSU
name: Chris Bell, PhD
role: PRINCIPAL_INVESTIGATOR
References: