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randomisation  (STATA Corporation)


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    STATA Corporation randomisation
    Randomisation, supplied by STATA Corporation, used in various techniques. Bioz Stars score: 99/100, based on 36112 PubMed citations. ZERO BIAS - scores, article reviews, protocol conditions and more
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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