Phase II trial code: 1066
| ISRCTN | ISRCTN35638452 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35638452 |
| Clinical Trials Information System (CTIS) | 2025-522359-24-00 |
| Integrated Research Application System (IRAS) | 1011840 |
| Protocol serial number | 1066 |
| Sponsor | University of Leicester |
| Funder | AstraZeneca |
- Submission date
- 07/08/2025
- Registration date
- 10/12/2025
- Last edited
- 10/12/2025
- Recruitment status
- Recruiting
- Overall study status
- Deferred
- Condition category
- Respiratory
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
Scientific
University of Leicester, University Road
Leicester
LE1 7RH
United Kingdom
| bsm19@leicester.ac.uk |
Scientific, Principal investigator
Glenfield Hospital
Leicester
LE5 4PW
United Kingdom
| Ceb17@leicester.ac.uk |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | Randomized controlled trial | |
| Masking | Blinded (masking used) | |
| Control | Placebo | |
| Assignment | Parallel | |
| Purpose | - | |
| Scientific title | Phase II trial code: 1066 | |
| 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 08/10/2025, Seasonal REC (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 104 8241; seasonal.rec@hrs.nhs.uk), ref: 25/LO/0628 | |
| 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 | 31/12/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 40 Years |
| Upper age limit | 85 Years |
| Sex | All |
| Target sample size at registration | 96 |
| 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 | 31/08/2025 |
| Date of final enrolment | 31/03/2027 |
Locations
Countries of recruitment
- United Kingdom
- Denmark
- Netherlands
- Spain
Study participating centre
NO COUNTRY SPECIFIED, assuming England
-
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan |
Editorial Notes
08/08/2025: Study's existence confirmed by Health Research Authority (HRA) (UK)
