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Safety of Inhaled Hydrogen Gas Mixtures in Healthy Volunteers

Sponsor
Boston Children's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04046211
Collaborator
(none)
8
Enrollment
1
Location
1
Arm
6.1
Actual Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Safety of Inhaled Hydrogen Gas Mixtures in Healthy Volunteers
Actual Study Start Date :
Oct 26, 2020
Actual Primary Completion Date :
May 1, 2021
Actual Study Completion Date :
May 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Adverse effects/symptoms [During inhalation exposure]

    Any adverse effects will be codified according the the NCI CTCAE v5.0

  2. Adverse effects/symptoms [2 hours following end of exposure period]

    Any adverse effects will be codified according the the NCI CTCAE v5.0

  3. Adverse effects/symptoms [24 hours following end of exposure period]

    Any adverse effects will be codified according the the NCI CTCAE v5.0

  4. Adverse effects/symptoms [5 days following end of exposure period]

    Any adverse effects will be codified according the the NCI CTCAE v5.0

Secondary Outcome Measures

  1. Change in mini-mental state exam [1 hour before end of exposure period]

    Numerical change in mini mental state exam

  2. Bedside spirometry [1 hour before end of exposure period]

    FEV1

  3. Bedside spirometry [1 hour before end of exposure period]

    Forced vital capacity

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Boston Children's Hospital Boston Massachusetts United States 02115

Sponsors and Collaborators

  • Boston Children's Hospital

Investigators

  • Principal Investigator: John Kheir, MD, Boston Children's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
John Kheir, Associate Professor, Harvard Medical School, Boston Children's Hospital
ClinicalTrials.gov Identifier:
NCT04046211
Other Study ID Numbers:
  • IRB-P00031196
First Posted:
Aug 6, 2019
Last Update Posted:
May 6, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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

Study Results

No Results Posted as of May 6, 2021