HealthyPhase 1NCT04046211
Safety of Inhaled Hydrogen Gas Mixtures in Healthy Volunteers
A Phase 1 study testing Hydrogen in people with Healthy, run by Boston Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Hydrogen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2020to 1 May 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 to 35
- Able to remain inpatient for duration of admission (24-72 hours)
Who cannot join
- History of any chronic illness, including respiratory disorders such as asthma, chronic obstructive pulmonary disease, prior acute lung injury or acute respiratory distress syndrome;
- Inflammatory disorders, such as lupus erythematosus, inflammatory bowel disease;
- Heritable disorders, such as trisomy 21, cystic fibrosis;
- Mitochondrial disorders;
- Currently smoking cigarettes or have a history of smoking cigarettes;
- The regular use of prescription medications (except for contraceptive medications) within 30 days of enrollment;
- Any lifetime inpatient hospitalization for respiratory illness;
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Hydrogen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrogenDrug
Gas exposure for 24, 48 or 72 hours via high flow nasal cannula.
| Study group | Role | What they receive |
|---|---|---|
| Hydrogen exposure | Experimental | 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. Receives: Drug: Hydrogen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse effects/symptoms
Any adverse effects will be codified according the the NCI CTCAE v5.0
Measured: During inhalation exposure
Adverse effects/symptoms
Any adverse effects will be codified according the the NCI CTCAE v5.0
Measured: 2 hours following end of exposure period
Adverse effects/symptoms
Any adverse effects will be codified according the the NCI CTCAE v5.0
Measured: 24 hours following end of exposure period
Adverse effects/symptoms
Any adverse effects will be codified according the the NCI CTCAE v5.0
Measured: 5 days following end of exposure period
Secondary outcomes (3)
Change in mini-mental state exam
Numerical change in mini mental state exam
Measured: 1 hour before end of exposure period
Bedside spirometry
FEV1
Measured: 1 hour before end of exposure period
Bedside spirometry
Forced vital capacity
Measured: 1 hour before end of exposure period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start26 Oct 2020
- Primary completion1 May 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Kheir, Boston Children's Hospital
- Investigators
- John Kheir, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04046211
- Sponsor's protocol ID
- IRB-P00031196
- Status last verified
- May 2021
- First submitted
- 25 Jul 2019
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be shared only with the FDA and members of the DSMB and IRB.
Publications
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.
PubMed 31061920
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Inhaled Hydrogen Gas Mixtures in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04046211
- Acronym / sponsor ID
- IRB-P00031196
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 26 Oct 2020 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 6 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hydrogen exposure | Experimental | Drug: HydrogenThe 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18 to 35
- Able to remain inpatient for duration of admission (24-72 hours)
Key exclusion criteria (8 listed)
- History of any chronic illness, including respiratory disorders such as asthma, chronic obstructive pulmonary disease, prior acute lung injury or acute respiratory distress syndrome;
- Inflammatory disorders, such as lupus erythematosus, inflammatory bowel disease;
- Heritable disorders, such as trisomy 21, cystic fibrosis;
- Mitochondrial disorders;
- Currently smoking cigarettes or have a history of smoking cigarettes;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydrogenGas exposure for 24, 48 or 72 hours via high flow nasal cannula. | Drug | Hydrogen exposure |
Primary outcome
Adverse effects/symptoms
Time frame: During inhalation exposure
Any adverse effects will be codified according the the NCI CTCAE v5.0
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
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
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
3 secondary outcomes
Change in mini-mental state exam
Time frame: 1 hour before end of exposure period
Bedside spirometry
Time frame: 1 hour before end of exposure period
Bedside spirometry
Time frame: 1 hour before end of exposure period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Results publication: PubMed 31061920Cole 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.
- Individual participant dataSharing planned: No. The data will be shared only with the FDA and members of the DSMB and IRB.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Kheir, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hydrogen in people with Healthy, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse effects/symptoms (time frame: During inhalation exposure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04046211, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2021.