Phase II trial: ETH47-201
| ISRCTN | ISRCTN21576805 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21576805 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 1011224 |
| Protocol serial number | ETH47-201 |
| Sponsor | Ethris GmbH |
| Funder | Ethris GmbH |
- Submission date
- 23/05/2025
- Registration date
- 03/06/2025
- Last edited
- 03/06/2025
- Recruitment status
- Recruiting
- Overall study status
- Deferred
- Condition category
- Other
Plain English summary of protocol
The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended
Contact information
Principal investigator
Imperial College Healthcare NHS Trust
South Wharf Road
London
W2 1NY
United Kingdom
| Phone | +44 (0)203 312 1344 |
|---|---|
| onn.kon@nhs.net |
Scientific
2 Royal College Street
London
NW1 0NH
United Kingdom
| Phone | +44 (0)20 7554 5855 |
|---|---|
| info@virtus-rr.com |
Public
2 Royal College Street
London
NW1 0NH
United Kingdom
| Phone | +44 (0)20 7554 5855 |
|---|---|
| info@virtus-rr.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Phase II double-blind randomized placebo-controlled study in 50 volunteers with asthma |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Phase II trial: ETH47-201 |
| Study objectives | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended |
| Ethics approval(s) |
Approved 14/02/2025, Wales 3 REC (Wales Research Ethics Committee 3, Health and Care Research Wales, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, United Kingdom; +44 (0)2922 941107; Wales.REC3@wales.nhs.uk), ref: 25/WA/0013 |
| Health condition(s) or problem(s) studied | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended |
| Intervention | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended |
| Intervention type | Drug |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended |
| Primary outcome measure(s) |
The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended |
| Key secondary outcome measure(s) |
The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended |
| Completion date | 12/05/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 50 |
| Key inclusion criteria | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended. |
| Key exclusion criteria | The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended |
| Date of first enrolment | 09/06/2025 |
| Date of final enrolment | 12/05/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Mint Wing
South Wharf Road
St Mary's Hospital
London
W2 1NY
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The datasets generated and/or analysed during the current study are not expected to be made available because of their high commercial sensitivity and the negligible benefit to the public of publication of results of non-therapeutic clinical trials |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
23/05/2025: Study's existence confirmed by the HRA.
