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An Alternative Way To Deliver Oxygen To People

Primary Purpose

Hypoxia

Status

Withdrawn

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Respirogen Micro-Oxygen

About this trial

This is an interventional health services research trial for Hypoxia

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Colorado State University, Dept. of Health and Exercise Science

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Low Oxygen Visits without Respirogen Micro-Oxygen

Low Oxygen Visits with Respirogen Micro-Oxygen

Arm Description

During each visit, study participants will undergo physiological monitoring prior to and during inhalation of hypoxic (FiO2=0.15) gas mixtures.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04870801

First Posted

April 29, 2021

Last Updated

June 27, 2022

Sponsor

Christopher Bell

Collaborators

Respirogen Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04870801

Brief Title

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

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Withdrawn

Why Stopped

The project was denied funding and the protocol was subsequently closed. No participants were enrolled.

Study Start Date

January 2022 (Anticipated)

Primary Completion Date

January 2024 (Anticipated)

Study Completion Date

January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Christopher Bell

Collaborators

Respirogen Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypoxia

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Early Phase 1

Interventional Study Model

Crossover Assignment

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)

Masking Description

Open label

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Low Oxygen Visits without Respirogen Micro-Oxygen

Arm Type

No Intervention

Arm Description

During each visit, study participants will undergo physiological monitoring prior to and during inhalation of hypoxic (FiO2=0.15) gas mixtures.

Arm Title

Low Oxygen Visits with Respirogen Micro-Oxygen

Arm Type

Experimental

Arm Description

During each visit, study participants will undergo physiological monitoring prior to and during inhalation of hypoxic (FiO2=0.15) gas mixtures.

Intervention Type

Drug

Intervention Name(s)

Respirogen Micro-Oxygen

Intervention Description

Enteral (rectal) delivery of Respirogen Micro-Oxygen

Primary Outcome Measure Information:

Title

Increases Oxygen saturation (SpO2) with RMO

Description

Enteral (rectal) delivery of without and with RMO to resting adult men and women during short-term breathing of hypoxic gas mixtures.

Time Frame

Randomized crossover, visits separated by a minimum 7 days and maxim 14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chris Bell, PhD

Organizational Affiliation

CSU

Official's Role

Principal Investigator

Facility Information:

Facility Name

Colorado State University, Dept. of Health and Exercise Science

City

Fort Collins

State/Province

Colorado

ZIP/Postal Code

80523-1582

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

An Alternative Way To Deliver Oxygen To People

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