An Alternative Way To Deliver Oxygen To People

Hypoxia Clinical Trial

Official title:

Evaluation of Respirogen Oxygen Microbubble Technology: Efficacy for Human Use During Rest in Normal and Low-oxygen Environments

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04870801
• Other study ID #: 20-10219H
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: January 2022
• Est. completion date: January 2024

Study information

• Verified date: June 2022
• Source: Colorado State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypoxia

Intervention

Drug:
• Respirogen Micro-Oxygen
Enteral (rectal) delivery of Respirogen Micro-Oxygen

Locations

Country	Name	City	State
United States	Colorado State University, Dept. of Health and Exercise Science	Fort Collins	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Christopher Bell	Respirogen Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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