Phase II trial: ETH47-201

ISRCTN	ISRCTN21576805
DOI	https://doi.org/10.1186/ISRCTN21576805
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: 11/05/2026

Recruitment status: Recruiting
Overall study status: Deferred
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Prof Onn Min Kon
Principal investigator

Imperial College Healthcare NHS Trust
South Wharf Road
London
W2 1NY
United Kingdom

Phone	+44 (0)203 312 1344
Email	onn.kon@nhs.net

Dr Michael Edwards
Scientific

2 Royal College Street
London
NW1 0NH
United Kingdom

Phone	+44 (0)20 7554 5855
Email	info@virtus-rr.com

Ms Tika Endeladze
Public

2 Royal College Street
London
NW1 0NH
United Kingdom

Phone	+44 (0)20 7554 5855
Email	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
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	15/08/2026

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	03/07/2026

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Imperial College Respiratory Research Unit

Imperial College Healthcare NHS Trust
Mint Wing
South Wharf Road
St Mary's Hospital
London
W2 1NY
England

Results and Publications

Individual participant data (IPD) Intention to share	No

Editorial Notes

11/05/2026: The following changes were made:
1. The date of final enrolment was changed from 12/05/2026 to 03/07/2026.
2. The completion date was changed from 12/05/2026 to 15/08/2026.
23/05/2025: Study's existence confirmed by the HRA.