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gcp compliant randomisation system  (Tayside Pharmaceuticals)

 
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    Tayside Pharmaceuticals gcp compliant randomisation system
    AIR-NET adaptive platform trial design summary . The AIR-NET randomised, open-label, multifactorial, multicentre adaptive platform trial has a parallel group design; the trial will open to recruitment with a control arm and the first three treatment arms indicated (oral dose: disulfiram 400 mg once daily; dipyridamole 200 mg twice daily; doxycycline 100 mg once daily. n=42/arm). All three drugs were chosen for their published anti-inflammatory and neutrophil modulatory activities, wide availability, and acceptable safety profiles. Potential participants will be screened for generic eligibility criteria, positive sputum neutrophil elastase lateral flow test and according to arm-specific criteria. Participants will receive 28 days treatment, with a further post-treatment follow-up at day 56. Individual treatment arms will be closed for <t>randomisation</t> when the target for number of participants has been reached, or earlier if advised by the data monitoring committee and closed to follow-up after last participant last visit for that arm. As new possibilities for treatments are identified additional treatment arms will be opened. Any new treatment arms will be submitted as an amendment to the current protocol. Randomisation to the control arm will continue for the duration of the trial. The primary outcome is change from baseline in sputum neutrophil elastase activity, analysis will be performed by pairwise comparison of each treatment arm to concurrent usual care participants, with analysis times varying by arm according to respective last participant last visit.
    Gcp Compliant Randomisation System, supplied by Tayside Pharmaceuticals, used in various techniques. Bioz Stars score: 86/100, based on 1 PubMed citations. ZERO BIAS - scores, article reviews, protocol conditions and more
    https://www.bioz.com/product/randomisations/compliant+gcp+randomisation+system/pmc12969703-132-9-12
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    Images

    1) Product Images from "Design and rationale of the AIR-NET trial: a randomised, open-label, multifactorial, multicentre, adaptive platform trial using a range of repurposed anti-inflammatory treatments to improve outcomes in patients with bronchiectasis within the EMBARC clinical research network"

    Article Title: Design and rationale of the AIR-NET trial: a randomised, open-label, multifactorial, multicentre, adaptive platform trial using a range of repurposed anti-inflammatory treatments to improve outcomes in patients with bronchiectasis within the EMBARC clinical research network

    Journal: ERJ Open Research

    doi: 10.1183/23120541.00719-2025

    AIR-NET adaptive platform trial design summary . The AIR-NET randomised, open-label, multifactorial, multicentre adaptive platform trial has a parallel group design; the trial will open to recruitment with a control arm and the first three treatment arms indicated (oral dose: disulfiram 400 mg once daily; dipyridamole 200 mg twice daily; doxycycline 100 mg once daily. n=42/arm). All three drugs were chosen for their published anti-inflammatory and neutrophil modulatory activities, wide availability, and acceptable safety profiles. Potential participants will be screened for generic eligibility criteria, positive sputum neutrophil elastase lateral flow test and according to arm-specific criteria. Participants will receive 28 days treatment, with a further post-treatment follow-up at day 56. Individual treatment arms will be closed for randomisation when the target for number of participants has been reached, or earlier if advised by the data monitoring committee and closed to follow-up after last participant last visit for that arm. As new possibilities for treatments are identified additional treatment arms will be opened. Any new treatment arms will be submitted as an amendment to the current protocol. Randomisation to the control arm will continue for the duration of the trial. The primary outcome is change from baseline in sputum neutrophil elastase activity, analysis will be performed by pairwise comparison of each treatment arm to concurrent usual care participants, with analysis times varying by arm according to respective last participant last visit.
    Figure Legend Snippet: AIR-NET adaptive platform trial design summary . The AIR-NET randomised, open-label, multifactorial, multicentre adaptive platform trial has a parallel group design; the trial will open to recruitment with a control arm and the first three treatment arms indicated (oral dose: disulfiram 400 mg once daily; dipyridamole 200 mg twice daily; doxycycline 100 mg once daily. n=42/arm). All three drugs were chosen for their published anti-inflammatory and neutrophil modulatory activities, wide availability, and acceptable safety profiles. Potential participants will be screened for generic eligibility criteria, positive sputum neutrophil elastase lateral flow test and according to arm-specific criteria. Participants will receive 28 days treatment, with a further post-treatment follow-up at day 56. Individual treatment arms will be closed for randomisation when the target for number of participants has been reached, or earlier if advised by the data monitoring committee and closed to follow-up after last participant last visit for that arm. As new possibilities for treatments are identified additional treatment arms will be opened. Any new treatment arms will be submitted as an amendment to the current protocol. Randomisation to the control arm will continue for the duration of the trial. The primary outcome is change from baseline in sputum neutrophil elastase activity, analysis will be performed by pairwise comparison of each treatment arm to concurrent usual care participants, with analysis times varying by arm according to respective last participant last visit.

    Techniques Used: Control, Activity Assay, Comparison

    Related Articles

    Blocking Assay:

    Article Title: Design and rationale of the AIR-NET trial: a randomised, open-label, multifactorial, multicentre, adaptive platform trial using a range of repurposed anti-inflammatory treatments to improve outcomes in patients with bronchiectasis within the EMBARC clinical research network
    Article Snippet: .. Please see licensing information on first page for reuse rights. https://publications.ersnet.orgDownloaded from Administrative information for the AIR-NET trial (1-5, 28) SPIRIT 2013 checklist details: Study title acronym (1) AIR-NET (Anti-Inflammatory Repurposing NETwork) Public Title (2b) Testing anti-inflammatories for the treatment of bronchiectasis Scientific Title (1 and 2b) A randomised, open-label, multifactorial, multicentre, platform trial using a range of repurposed antiinflammatory treatments to improve outcomes in patients with bronchiectasis not due to cystic fibrosis, within the EMBARC international clinical research network WHO Trial Registration Data Set (version 1.3.1) (2b) Primary Registry and Trial Identifying Number (2a and 2b) ISRCTN17596258 Date of Registration in Primary Registry 23/10/2024 Secondary Identifying Numbers 1-027-24, CPMS 62256 Source(s) of Monetary or Material Support (2b and 4) LifeArc Primary Sponsor (2b and 5b) University of Dundee and NHS Tayside Contact details: Patricia Burns, Senior Research Governance Manager, Research & Development Office, TASC, Residency Block Level 3, George Pirie Way, Ninewells Hospital, Dundee DD1 9SY, +44 1382 383297, TASCgovernance@dundee.ac.uk Secondary Sponsor(s) n/a Contact for Public Queries Professor James Chalmers, study Chief Investigator (j.chalmers@dundee.ac.uk; Ninewells Hospital, Dundee, United Kingdom, DD1 9SY, +44 1382 386131) and the study team airnettm@dundee.ac.uk Contact for Scientific Queries Professor James Chalmers, study Chief Investigator (j.chalmers@dundee.ac.uk; Ninewells Hospital, Dundee, United Kingdom, DD1 9SY, +44 1382 386131) and the study team airnettm@dundee.ac.uk Countries of Recruitment United Kingdon Health Condition(s) or Problem(s) Studied Adult Bronchiectasis Intervention(s) Participants will be randomised using the online Tayside Randomisation System (TRuST) to one of the trial arms: Arm 1: Usual care Arm 2: Disulfiram 200 mg, two tablets taken orally, once daily on December 3, 2025 by guest. ..

    Clinical Proteomics:

    Article Title: Cognitive behavioural therapy with optional graded exercise therapy in patients with severe fatigue with myotonic dystrophy type 1: a multicentre, single-blind, randomised trial
    Article Snippet: .. Randomisation was done via the central Tayside Randomisation webbased system (TRuST) developed by the Tayside Clinical Trials Unit (University of Dundee, Dundee, UK). ..

    Article Title: Audit and feedback: effects on professional practice
    Article Snippet: Audit and feedback: e ects on professional practice (Review) Copyright © 2025 The Cochrane Collaboration.. Published by John Wiley & Sons, Ltd. 2 Cochrane Library Trusted evidence.. Informed decisions.

    other:

    Article Title: Design and rationale of the AIR-NET trial: a randomised, open-label, multifactorial, multicentre, adaptive platform trial using a range of repurposed anti-inflammatory treatments to improve outcomes in patients with bronchiectasis within the EMBARC clinical research network
    Article Snippet: Randomisation will be done via the centrally controlled, web-based, GCP-compliant randomisation system, Tayside Randomisation System (TRuST), run by the Health Informatics Centre (University of Dundee), with allocation provided via email.



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    AIR-NET adaptive platform trial design summary . The AIR-NET randomised, open-label, multifactorial, multicentre adaptive platform trial has a parallel group design; the trial will open to recruitment with a control arm and the first three treatment arms indicated (oral dose: disulfiram 400 mg once daily; dipyridamole 200 mg twice daily; doxycycline 100 mg once daily. n=42/arm). All three drugs were chosen for their published anti-inflammatory and neutrophil modulatory activities, wide availability, and acceptable safety profiles. Potential participants will be screened for generic eligibility criteria, positive sputum neutrophil elastase lateral flow test and according to arm-specific criteria. Participants will receive 28 days treatment, with a further post-treatment follow-up at day 56. Individual treatment arms will be closed for <t>randomisation</t> when the target for number of participants has been reached, or earlier if advised by the data monitoring committee and closed to follow-up after last participant last visit for that arm. As new possibilities for treatments are identified additional treatment arms will be opened. Any new treatment arms will be submitted as an amendment to the current protocol. Randomisation to the control arm will continue for the duration of the trial. The primary outcome is change from baseline in sputum neutrophil elastase activity, analysis will be performed by pairwise comparison of each treatment arm to concurrent usual care participants, with analysis times varying by arm according to respective last participant last visit.
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    AIR-NET adaptive platform trial design summary . The AIR-NET randomised, open-label, multifactorial, multicentre adaptive platform trial has a parallel group design; the trial will open to recruitment with a control arm and the first three treatment arms indicated (oral dose: disulfiram 400 mg once daily; dipyridamole 200 mg twice daily; doxycycline 100 mg once daily. n=42/arm). All three drugs were chosen for their published anti-inflammatory and neutrophil modulatory activities, wide availability, and acceptable safety profiles. Potential participants will be screened for generic eligibility criteria, positive sputum neutrophil elastase lateral flow test and according to arm-specific criteria. Participants will receive 28 days treatment, with a further post-treatment follow-up at day 56. Individual treatment arms will be closed for randomisation when the target for number of participants has been reached, or earlier if advised by the data monitoring committee and closed to follow-up after last participant last visit for that arm. As new possibilities for treatments are identified additional treatment arms will be opened. Any new treatment arms will be submitted as an amendment to the current protocol. Randomisation to the control arm will continue for the duration of the trial. The primary outcome is change from baseline in sputum neutrophil elastase activity, analysis will be performed by pairwise comparison of each treatment arm to concurrent usual care participants, with analysis times varying by arm according to respective last participant last visit.

    Journal: ERJ Open Research

    Article Title: Design and rationale of the AIR-NET trial: a randomised, open-label, multifactorial, multicentre, adaptive platform trial using a range of repurposed anti-inflammatory treatments to improve outcomes in patients with bronchiectasis within the EMBARC clinical research network

    doi: 10.1183/23120541.00719-2025

    Figure Lengend Snippet: AIR-NET adaptive platform trial design summary . The AIR-NET randomised, open-label, multifactorial, multicentre adaptive platform trial has a parallel group design; the trial will open to recruitment with a control arm and the first three treatment arms indicated (oral dose: disulfiram 400 mg once daily; dipyridamole 200 mg twice daily; doxycycline 100 mg once daily. n=42/arm). All three drugs were chosen for their published anti-inflammatory and neutrophil modulatory activities, wide availability, and acceptable safety profiles. Potential participants will be screened for generic eligibility criteria, positive sputum neutrophil elastase lateral flow test and according to arm-specific criteria. Participants will receive 28 days treatment, with a further post-treatment follow-up at day 56. Individual treatment arms will be closed for randomisation when the target for number of participants has been reached, or earlier if advised by the data monitoring committee and closed to follow-up after last participant last visit for that arm. As new possibilities for treatments are identified additional treatment arms will be opened. Any new treatment arms will be submitted as an amendment to the current protocol. Randomisation to the control arm will continue for the duration of the trial. The primary outcome is change from baseline in sputum neutrophil elastase activity, analysis will be performed by pairwise comparison of each treatment arm to concurrent usual care participants, with analysis times varying by arm according to respective last participant last visit.

    Article Snippet: Randomisation will be done via the centrally controlled, web-based, GCP-compliant randomisation system, Tayside Randomisation System (TRuST), run by the Health Informatics Centre (University of Dundee), with allocation provided via email.

    Techniques: Control, Activity Assay, Comparison