Steroid Withdrawal Intervention in Fife and Tayside

NCT03489746 | Withdrawn

• 1 other identifier: 2016RC23
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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

Chronic Obstructive Pulmonary Disease

Keywords

Inhaled corticosteroids; Quality improvement; Cluster randomized Trial

Outcome Measures

Primary Outcomes (1)

• Frequency of moderate and severe exacerbations of COPD

  Use of corticosteroids and/or antibiotics (moderate) or hospitalization (severe) for exacerbation of COPD

  1 year

Secondary Outcomes (5)

• Respiratory Hospitalizations

  1 year

• Success of ICS withdrawal

  1 year

• Time to the first moderate and severe exacerbation

  Time to first event (patients without an event censored at 1 year)

• Oral corticosteroid use

  1 year

• Antibiotic use

  1 year

Other Outcomes (6)

• Rates of known ICS related adverse effects between groups

  1 year

• Rates of ICS relapse

  1 year

• Mortality

  1 year

Study Arms (2)

Inhaled corticosteroid withdrawal

EXPERIMENTAL

Patients meeting the study criteria for withdrawal will have their ICS containing regime changed to a LABA/LAMA regime without ICS.

Other: ICS withdrawal protocol

Standard care

ACTIVE COMPARATOR

Patients will continue on their current recommended regimen including ICS.

Other: Standard care

Interventions

ICS withdrawal protocol OTHER

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

Inhaled corticosteroid withdrawal

Standard care OTHER

Normal clinically indicated inhaled therapy

Standard care

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients aged \> 40 years
• A clinical diagnosis of COPD made by a physician
• Post-bronchodilator FEV1/FVC ratio at screening of \<70%

You may not qualify if:

• Asthma recorded in general practice records or clinically suspected
• Patients with COPD receiving inhaled short acting beta-2 agonist only.
• Residence outwith Tayside and Fife
• Insufficient data available to determine appropriateness of ICS and other medication use.
• Known previous failure of inhaled corticosteroid withdrawal
• Patients should be excluded if, in the opinion of the practice, making changes to their current COPD treatment regime is not in the patients best interests.

Sponsors & Collaborators

• NHS Tayside: lead
• NHS Fife: collaborator

Study Sites (2)

NHS Tayside

Dundee, Perthshire, DD1 9SY, United Kingdom

Location

NHS FIfe

Kirkcaldy, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Philip M Short

  NHS Tayside

  PRINCIPAL INVESTIGATOR

• Devesh Dhasmana

  NHS Fife

  PRINCIPAL INVESTIGATOR

• Arlene Shaw

  NHS Tayside

  STUDY DIRECTOR

• Fiona Eastop

  NHS Tayside

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All data will be analysed anonymously
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Cluster randomized controlled trial at practice level

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: April 5, 2018
• Study Start: May 1, 2018
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 20, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: To be determined
• Access Criteria: Open

Locations

GB (2)