Amendments

Here is the list of study wide amendments made to the study.

Current approved documents can be found in the study document depository.

Substantial Amendment 1

Amendment summary:
  • Change to the inclusion criteria of the protocol (to simplify the asthma exacerbation history required for entry into the trial).

Status:

This amendment it still awaiting regulatory body (HRA/MHRA/REC) approval.

Once the regulatory body approvals are sent to the local teams, please can this amendment be processed and implemented as soon as possible to ensure that the research teams are able to maximise recruitment before the end of October.

Associated document(s):

  • Protocol [Version 3.0; dated 12-SEP-2025]

Non-substantial Amendment 1 (NSA01)

Amendment summary:
  • Updated IMP reconciliation process.
  • Removal of specific IgE blood tests for participants (in the main study) at Visit 1.
  • Confirmation that only liver function tests should be reviewed for safety purposes at screening.

Status:

Approved by HRA on 20-AUG-2025 (with no review required by MHRA/REC).

Associated document(s):

  • IMP Label Template [Version 3.0; dated 30-JUL-2025]
  • Patient Information Sheet (main study) [Version 2.1; dated 01-AUG-2025]
  • Protocol [Version 2.1; dated 06-AUG-2025]
  • Study Contact Card [Version 1.1; dated 29-JUL-2025]

Non-substantial Amendment 2 (NSA02)

Amendment summary:
  • Minor corrections to the Protocol:
    • Study Visit 1 can be conducted across two visits (as long as it is completed within seven days of the initial visit).
    • Clarification to exclusion criterion (#7) referring to parasitic infections.
  • Updated formatting in Informed Consent Form

Status:

Approved by HRA on 09-SEP-2025 (with no review required by MHRA/REC).

Associated document(s):

  • Informed Consent Form (main study) [Version 1.1; dated 04-SEP-2025]
  • Protocol [Version 2.2; dated 02-SEP-2025]

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