The Effect of Inhaled Nitric Oxide on Maximal Oxygen Consumption During Exercise in Hypoxia

NCT04231773 | Completed Phase 1

• 1 other identifier: Pro00092939
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

During exercise in conditions of low oxygen (termed hypoxia), such as mountaineering at high altitudes, the lung blood vessels constrict in an attempt to protect the body from the negative effects of hypoxia. It appears that this blood vessel constriction may limit the heart to pump blood during heavy exercise, leading to reductions in exercise performance. Inhaled nitric oxide is a drug that is known to relax the lung blood vessels. Inhaled nitric oxide has been used to relax lung blood vessels and improve exercise capacity in patients with chronic disease. It is unknown if similar improvements would be observed during exercise in healthy individuals when exposed to low levels of oxygen. The goal of this study is to determine if inhaled nitric oxide can relax the lung blood vessels and improve the heart's pumping ability during exercise in low oxygen conditions. Further, the investigators will determine if these improvements in lung blood vessel and heart function increase exercise performance. Participants will complete 6 sessions over a three week period where they will perform exercise challenges while breathing low levels of oxygen with and without inhaled nitric oxide. The low oxygen conditions will be comparable to being at an altitude of 14,000-17,000 feet. 17,000 feet would be equivalent to standing on the summit of King Peak in the Yukon (the 4th tallest mountain in Canada).

Conditions

Hypoxia

Outcome Measures

Primary Outcomes (1)

• Exercise Capacity

  Exercise capacity as determined by maximal oxygen consumption (V̇O2max)

  Within 20-25 minutes post-dose

Secondary Outcomes (2)

• Cardiac Output

  Within 20-25 minutes post-dose

• Pulmonary artery pressure

  Within 20-25 minutes post-dose

Study Arms (4)

12.1% Oxygen and Inhaled Nitric Oxide

EXPERIMENTAL

Moderate level of hypoxia (12.1% Oxygen) and Inhaled Nitric Oxide (40 ppm)

Drug: Nitric Oxide

12.1 % Oxygen Placebo

PLACEBO COMPARATOR

Moderate level of hypoxia (12.1 % Oxygen) and Placebo (0 ppm Nitric Oxide)

Drug: Placebo

13.6 % Oxygen and Inhaled Nitric Oxide

EXPERIMENTAL

Severe level of hypoxia (13.6% Oxygen) and Inhaled Nitric Oxide (40 ppm)

Drug: Nitric Oxide

13.6 % Oxygen and Placebo

PLACEBO COMPARATOR

Severe level of hypoxia (13.6% Oxygen) and Placebo (0 ppm Nitric Oxide)

Drug: Placebo

Interventions

Nitric Oxide DRUG

40 parts per million dosage

Also known as: iNO

12.1% Oxygen and Inhaled Nitric Oxide; 13.6 % Oxygen and Inhaled Nitric Oxide

Placebo DRUG

Inhaled placebo. Device connected to same delivery system, but does not deliver nitric oxide.

Also known as: Hypoxic Placebo

12.1 % Oxygen Placebo; 13.6 % Oxygen and Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Non-smokers and less than 10 pack years smoking history
• Young healthy males and females with normal lung function and no known history of cardiopulmonary disease.

You may not qualify if:

• Individuals with significant cardiovascular, metabolic, neuromuscular or any other disease that could contribute to abnormal respiratory and cardiovascular responses to exercise will be excluded.
• Individuals with musculoskeletal injuries that prevent them from completing cycle ergometry exercise trials will be excluded.
• For safety reasons, pregnant females will be excluded.
• Participants currently on oral steroids (i.e. prednisone) or phosphodiesterase type 5 (PDE5) inhibitors will be excluded.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Clinical Physiology Laboratory

Edmonton, Alberta, T6G2R3, Canada

Location

MeSH Terms

Conditions

Hypoxia

Interventions

Nitric Oxide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Reactive Nitrogen Species; Free Radicals; Inorganic Chemicals; Nitrogen Oxides; Nitrogen Compounds; Oxides; Oxygen Compounds; Organic Chemicals

Study Officials

• Micahel Stickland, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: January 18, 2020
• Study Start: August 17, 2020
• Primary Completion: December 4, 2021
• Study Completion: December 4, 2021
• Last Updated: September 19, 2024

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)