Safety of Inhaled Hydrogen Gas Mixtures in Healthy Volunteers

May 4, 2021 updated by: John Kheir, Boston Children's Hospital
Hydrogen gas may decrease the degree or incidence of brain injury following ischemia. The purpose of this study is to determine the safety and tolerability of inhaled hydrogen gas at the dose exposures required for a clinical efficacy study in healthy adult participants. Participants will breathe a gas mixture that contains a low concentration of hydrogen gas in air through a high flow nasal cannula. Investigators will test for any changes in breathing and neurologic status, as well as lab tests during and following the exposure period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Inhaled hydrogen gas (H2) has been shown to have significant protective effects on ischemic organs. Clinical trials abroad have shown promise that treatment of patients suffering from stroke, cardiac arrest, or heart attacks may benefit from inhaling hydrogen gas during the early recovery period.

The purpose of this study is to determine the safety and tolerability of inhaled hydrogen gas at the dose exposures required for a clinical efficacy study in healthy adult volunteers.

Study design. Eight (8) healthy adult participants will be recruited from the greater Boston area for this study. Consenting participants will be admitted to the hospital and will undergo a series of screens (questionnaires, examination, tests) to ensure suitability to participate. Eligible and consenting participants will then undergo exposure to 2.4% H2 in medical air via high flow nasal cannula for either 24 (n=2), 48 (n=2) or 72 (n=4) hours. Participants will be screened for adverse effects as follows: vital signs every 8 hours, nursing assessment of symptoms (codified based on the National Cancer Institute's Common Terminology Criteria for Adverse Events, CTCAE) every 8 hours, bedside spirometry daily, mini-mental state exam daily, physician physical exam daily, and serum testing (blood count, chemistry, liver and coagulation profile, venous blood gas) following exposure period.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Boston Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18 to 35
  2. Able to remain inpatient for duration of admission (24-72 hours)

Exclusion Criteria:

  1. History of any chronic illness, including respiratory disorders such as asthma, chronic obstructive pulmonary disease, prior acute lung injury or acute respiratory distress syndrome;
  2. Inflammatory disorders, such as lupus erythematosus, inflammatory bowel disease;
  3. Heritable disorders, such as trisomy 21, cystic fibrosis;
  4. Mitochondrial disorders;
  5. Currently smoking cigarettes or have a history of smoking cigarettes;
  6. The regular use of prescription medications (except for contraceptive medications) within 30 days of enrollment;
  7. Any lifetime inpatient hospitalization for respiratory illness;
  8. Pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Hydrogen exposure
The first two patients will be exposed to 2.4% hydrogen gas in medical air via HFNC for 24 hours. The second two patients will be exposed to the same gas for 48 hours. The final 4 patients will be exposed to the same gas for 72 hours.
Drug: Hydrogen
Gas exposure for 24, 48 or 72 hours via high flow nasal cannula.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse effects/symptoms
Time Frame: During inhalation exposure
Any adverse effects will be codified according the the NCI CTCAE v5.0
During inhalation exposure
Adverse effects/symptoms
Time Frame: 2 hours following end of exposure period
Any adverse effects will be codified according the the NCI CTCAE v5.0
2 hours following end of exposure period
Adverse effects/symptoms
Time Frame: 24 hours following end of exposure period
Any adverse effects will be codified according the the NCI CTCAE v5.0
24 hours following end of exposure period
Adverse effects/symptoms
Time Frame: 5 days following end of exposure period
Any adverse effects will be codified according the the NCI CTCAE v5.0
5 days following end of exposure period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in mini-mental state exam
Time Frame: 1 hour before end of exposure period
Numerical change in mini mental state exam
1 hour before end of exposure period
Bedside spirometry
Time Frame: 1 hour before end of exposure period
FEV1
1 hour before end of exposure period
Bedside spirometry
Time Frame: 1 hour before end of exposure period
Forced vital capacity
1 hour before end of exposure period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 26, 2020

Primary Completion (ACTUAL)

May 1, 2021

Study Completion (ACTUAL)

May 1, 2021

Study Registration Dates

First Submitted

July 25, 2019

First Submitted That Met QC Criteria

August 2, 2019

First Posted (ACTUAL)

August 6, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 6, 2021

Last Update Submitted That Met QC Criteria

May 4, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • IRB-P00031196

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data will be shared only with the FDA and members of the DSMB and IRB.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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