An Alternative Way To Deliver Oxygen To People

NCT04870801 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: 20-10219H
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Low Oxygen Visits without Respirogen Micro-Oxygen

NO INTERVENTION

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

Low Oxygen Visits with Respirogen Micro-Oxygen

EXPERIMENTAL

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

Interventions

Respirogen Micro-Oxygen DRUG

Enteral (rectal) delivery of Respirogen Micro-Oxygen

Low Oxygen Visits with Respirogen Micro-Oxygen

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Christopher Bell: lead
• Respirogen Inc.: collaborator

Study Sites (1)

Colorado State University, Dept. of Health and Exercise Science

Fort Collins, Colorado, 80523-1582, United States

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chris Bell, PhD

  CSU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 4, 2021
• Study Start: January 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: June 30, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)