Phase II trial: ETH47-201
| ISRCTN | ISRCTN21576805 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21576805 |
| IRAS number | 1011224 |
| Secondary identifying numbers | ETH47-201 |
- 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
| Study design | Phase II double-blind randomized placebo-controlled study in 50 volunteers with asthma |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format |
| 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 |
| Pharmaceutical study type(s) | Other - 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. |
| 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 | 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 |
| Secondary outcome measures | 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 |
| Overall study start date | 15/11/2024 |
| Completion date | 12/05/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Mint Wing
South Wharf Road
St Mary's Hospital
London
W2 1NY
United Kingdom
Sponsor information
Industry
Semmelweisstrasse 3
Planegg
82152
Germany
| Phone | +49 (0)89 89557880 |
|---|---|
| info@ethris.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 12/11/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Full trial details will be published up to 30 months after the end of the trial. Publication of some trial details is deferred because of the high commercial sensitivity of this Phase II study. Results may be posted on or after the date of publication of full trial details. |
| 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 |
Editorial Notes
23/05/2025: Study's existence confirmed by the HRA.
