Safety evaluation of low-level chlorine in water aerosol when inhaled by healthy volunteers
| ISRCTN | ISRCTN13034712 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13034712 |
| Secondary identifying numbers | HS4-20 SE |
- Submission date
- 03/12/2021
- Registration date
- 15/12/2021
- Last edited
- 15/12/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims.
Human white blood cells produce aqueous (dissolved) chlorine that has been reproduced as HS4-20 and used to prevent wound infection and inflammation when administered to the skin and other surfaces. It is believed that this would be beneficial when administered to the airways and lungs to treat lung and airway diseases. The study is designed to discover if HS4-20 is safe to administer as an aerosol and breathe. The study is designed to begin at a short exposure of 30 seconds and, if safe to do so, increase exposure to 90 minutes over several days and in up to 18 healthy volunteers.
Who can participate?
Healthy volunteers
What does the study involve?
The participants breathe in aerosolised HS4-20 over several days and escalating from 30 seconds to 90 minutes.
What are the possible benefits and risks of participating?
There are no expected benefits. The possible risk of participation is increased expectoration (spitting) or mild coughing
Where is the study run from?
Hypo-Stream (UK)
When is the study starting and how long is it expected to run for?
May 2015 to September 2020.
Who is funding the study?
Hypo-Stream Ltd (UK)
Who is the main contact?
Myles Dakin
myles.dakin@hypo-stream.com
Contact information
Public
Hypo-Stream Cambridge
Unit 9 Beech House
Melbourn Science Park
Melbourn
Cambridge
SG8 6HB
United Kingdom
 ORCID ID |
0000-0002-0294-4908 |
|---|---|
| Phone | +44 (0)1763 261129 |
| myles.dakin@hypo-stream.com |
Study information
| Study design | Open-label exposure-escalation study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | 40759_PIS.pdf |
| Scientific title | Open-label, exposure-escalation study to evaluate the safety and tolerability of nebulised HS4-20 in healthy volunteers |
| Study acronym | SEHS4-20 |
| Study objectives | That inhalation of HS4-20 via a nebuliser is is safe and without adverse events over long periods of time. |
| Ethics approval(s) | Ethics approval not required. An open-label, exposure escalation study was planned following a safety evaluation via formal scientific advice from the HMRA and subsequent formal scientific advice from the EMA. The study was planned and directed by Prof. R Aspinall (translational medicine) and Dr Thomas Kenny (formerly director at NIHR). |
| Health condition(s) or problem(s) studied | Safety evaluation of nebulised HS4-20 physiologic aqueous chlorine aerosol |
| Intervention | Pulmonary administration of HS4-20 as an aerosol via a nebuliser. The healthy volunteers were divided into three cohorts: 1. Two adults. Exposure escalation from 30 seconds increasing to 30 minutes. A subsequent day exposure escalation from 5 minutes escalating to 90 minutes. 2. Four adults. Exposure escalation from 30 seconds to 20 minutes. Subsequent day exposure for 20 minutes repeated twice. 3. 12 adults and children. An induction phase of 5 minutes escalating to 20 minutes. Subsequent day exposure of 20 minutes. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | HS4-20 |
| Primary outcome measure | Treatment-emergent adverse events measured using observation for the absence of abnormality and of coordination by a clinically trained investigator over a 30-minute period following administration. Follow-up was 7 days post-administration self-reporting. The final follow-up was over a 12-month period of self-reporting and investigator interview. |
| Secondary outcome measures | 1. Blood pressure measured with an automatic upper arm cuff sphygmomanometer (Omron X3) at baseline (pre-administration), 30 seconds, 2, 5, 10, 20, 30 minutes post-administration in first and second cohorts, the third cohort was measured at 30 seconds, 5, 20, 30 minutes 2. Oxygen saturation measured by pulse oximeter (Braun Healthcare Pulse Oximeter 1) throughout the periods of exposure and for 30 minutes after cessation of administration |
| Overall study start date | 02/05/2015 |
| Completion date | 20/09/2020 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | All |
| Sex | Both |
| Target number of participants | 18 |
| Total final enrolment | 18 |
| Key inclusion criteria | Healthy volunteers, no exclusions on basis of age or gender |
| Key exclusion criteria | Does not meet the inclusion criteria |
| Date of first enrolment | 01/06/2015 |
| Date of final enrolment | 20/09/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Melbourn Science Park
Melbourn
Cambridge
SG8 6HB
United Kingdom
Sponsor information
Industry
c/o Dr Thomas Kenny
31A Charnham Street
Hungerford
RG17 0EG
England
United Kingdom
| Phone | +44 (0)7973665236 |
|---|---|
| tdkenny@doctors.org.uk | |
| Website | https://www.hypo-stream.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 02/02/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high impact peer-reviewed journal from the Nature group. |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 09/12/2021 | No | Yes | ||
| Protocol file | version 1.0 | 09/12/2021 | No | No |
Additional files
Editorial Notes
15/12/2021: Trial's existence confirmed by Hypo-Stream Ltd.
