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Steroid Withdrawal Intervention in Fife and Tayside

NCT03489746 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-03-20

No results posted yet for this study

Summary

The SWIFT trial is a cluster randomised trial to determine if a patient identification, feedback and inhaled corticosteroid (ICS) withdrawal intervention in primary care can result in more appropriate inhaled corticosteroid use without increasing the frequency of exacerbations. Practices in Tayside and Fife will be randomised at practice level to an intervention or control. The intervention will consist of electronic review of patients Chronic obstructive pulmonary disease (COPD) data and prescribing history, followed by implementation of a medication change involving withdrawal of ICS and introduction of a Long acting beta adrenergic agonist (LABA) and Long acting muscarinic antagonist (LAMA) for patients without an indication for ongoing ICS treatment. Patients in control practices will not receive the intervention, but practices will be provided with local guidelines and formulary and encouraged to prescribe appropriately. Patients in the control practices may be switched to guideline compliant medications. Our hypothesis is that removal of non-evidence barriers to appropriate prescribing will result in in high rates of ICS withdrawal and that the intervention will be safe, as evidenced by no increase in the frequency of exacerbations over 12 months of follow-up.

Conditions

Interventions

OTHER

ICS withdrawal protocol

A primary care intervention to support switch from ICS containing regimen to non-ICS containing regimen in appropriate patients.

OTHER

Standard care

Normal clinically indicated inhaled therapy

Sponsors & Collaborators

  • NHS Fife

    collaborator OTHER_GOV

  • NHS Tayside

    lead OTHER_GOV

Principal Investigators

  • Philip M Short · NHS Tayside

  • Devesh Dhasmana · NHS Fife

  • Arlene Shaw · NHS Tayside

  • Fiona Eastop · NHS Tayside

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03489746 on ClinicalTrials.gov