An Alternative Way To Deliver Oxygen To People

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.

Study Overview

• Status: Withdrawn
• Conditions: Hypoxia
• Intervention / Treatment: Drug: Respirogen Micro-Oxygen

• Study Type: Interventional
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Fort Collins, Colorado, United States, 80523-1582
      • Colorado State University, Dept. of Health and Exercise Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Low Oxygen Visits without Respirogen Micro-Oxygen; During each visit, study participants will undergo physiological monitoring prior to and during inhalation of hypoxic (FiO2=0.15) gas mixtures.
EXPERIMENTAL: Low Oxygen Visits with Respirogen Micro-Oxygen; During each visit, study participants will undergo physiological monitoring prior to and during inhalation of hypoxic (FiO2=0.15) gas mixtures.	Drug: Respirogen Micro-Oxygen; Enteral (rectal) delivery of Respirogen Micro-Oxygen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Randomized crossover, visits separated by a minimum 7 days and maxim 14 days

Collaborators and Investigators

• Sponsor: Christopher Bell
• Collaborators: Respirogen Inc.
• Investigators: Principal Investigator: Chris Bell, PhD, CSU

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2022
• Primary Completion (ANTICIPATED): January 1, 2024
• Study Completion (ANTICIPATED): January 1, 2024

Study Registration Dates

• First Submitted: April 29, 2021
• First Submitted That Met QC Criteria: April 29, 2021
• First Posted (ACTUAL): May 4, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 30, 2022
• Last Update Submitted That Met QC Criteria: June 27, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: 20-10219H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No