Clinical trial NCT04046211: Safety of Inhaled Hydrogen Gas Mixtures in Healthy Volunteers
Official title: Safety of Inhaled Hydrogen Gas Mixtures in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2019-08-06
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Adverse effects/symptoms
timeFrame: During inhalation exposure
measure: Adverse effects/symptoms
timeFrame: 2 hours following end of exposure period
measure: Adverse effects/symptoms
timeFrame: 24 hours following end of exposure period
measure: Adverse effects/symptoms
timeFrame: 5 days following end of exposure period
Secondary outcomes:
measure: Change in mini-mental state exam
timeFrame: 1 hour before end of exposure period
measure: Bedside spirometry
timeFrame: 1 hour before end of exposure period
measure: Bedside spirometry
timeFrame: 1 hour before end of exposure period
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: John Kheir, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cole AR, Perry DA, Raza A, Nedder AP, Pollack E, Regan WL, van den Bosch SJ, Polizzotti BD, Yang E, Davila D, Afacan O, Warfield SK, Ou Y, Sefton B, Everett AD, Neil JJ, Lidov HGW, Mayer JE, Kheir JN. Perioperatively Inhaled Hydrogen Gas Diminishes Neurologic Injury Following Experimental Circulatory Arrest in Swine. JACC Basic Transl Sci. 2019 Mar 27;4(2):176-187. doi: 10.1016/j.jacbts.2018.11.006. eCollection 2019 Apr.