An Alternative Way To Deliver Oxygen To People

Early Phase 1

Withdrawn

• Conditions: Hypoxia
• Interventions: Drug: Respirogen Micro-Oxygen

• Registration Number: NCT04870801
• Lead Sponsor: Christopher Bell

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-29
• Study First Submitted QC: 2021-04-29
• Study First Posted: 2021-05-04
• Study Start: 2022-01
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-27
• Last Update Posted: 2022-06-30
• Primary Completion: 2024-01
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Low Oxygen Visits with Respirogen Micro-Oxygen	Respirogen Micro-Oxygen	During each visit, study participants will undergo physiological monitoring prior to and during inhalation of hypoxic (FiO2=0.15) gas mixtures.

Primary Outcome Measures

Name	Time	Method
Increases Oxygen saturation (SpO2) with RMO	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.

Trial Locations

Locations (1)

Colorado State University, Dept. of Health and Exercise Science; 🇺🇸 Fort Collins, Colorado, United States