Steroid Withdrawal Intervention in Fife and Tayside (SWIFT)

A Cluster Randomised Trial of Medication Review and Withdrawal of Inappropriate Inhaled Corticosteroid Treatment in Chronic Obstructive Pulmonary Disease

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.

Study Overview

• Status: Withdrawn
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: ICS withdrawal protocol; Other: Standard care

Detailed Description

Chronic obstructive pulmonary disease (COPD) is the third leading cause of death worldwide and a major cause of morbidity in the UK. Inhaled corticosteroids (ICS) are frequently prescribed to patients with COPD and these medications represent a major burden on the National Health Service in terms of drug costs. They are not without side effects, and pneumonia in particularly has been highlighted as a common adverse event in COPD patients receiving ICS.

In the UK, inhaled corticosteroids are indicated for patients with severe or very severe COPD (Forced expiratory volume in 1 second <50% predicted) who experience frequent exacerbations. International guidelines and strategies such as those from Global Obstructive Lung Disease (GOLD), also suggest inhaled corticosteroids should be reserved for patients with frequent exacerbations despite appropriate treatment with inhaled bronchodilators such as combined long acting beta-agonists and long acting muscarinic antagonists (LABA/LAMA combinations). Despite this guidance, use of inhaled corticosteroids in patients with milder COPD and without a history of exacerbations is common. Randomised controlled trials suggest that inhaled corticosteroids can be withdrawn from COPD patients with minimal adverse effects. Attempts to reduce inappropriate ICS prescribing have been largely unsuccessful in real-life, however, because of "non-evidence barriers". These include a lack of expertise in general practice to identify patients suitable for ICS withdrawal, fear of adrenal insufficiency, concern about missing a diagnosis of asthma and time. A high proportion of COPD care in the United Kingdom is delivered by specialist practice nurses, who may not be empowered to withdraw ICS in the absence of specific guidance or protocols.

The SWIFT trial is a cluster randomised trial to determine if a patient identification, feedback and 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 COPD data and prescribing history, followed by implementation of a medication change involving withdrawal of ICS and introduction of a LABA/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 (which may include the withdrawal of inhaled corticosteroids).

Our hypothesis is that the above "non-evidence barriers" will result in an ongoing high inappropriate use of ICS in control practices while an intervention that overcomes these will result 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.

This study will make an important contribution to understanding the role of inhaled corticosteroids in COPD. If successful, the intervention could be safely applied throughout the NHS to reduce inappropriate medication use, reduce patient side effects and healthcare costs.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Kirkcaldy, United Kingdom
    • NHS FIFE
  • Perthshire
    • Dundee, Perthshire, United Kingdom, DD1 9SY
      • NHS Tayside

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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%

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Inhaled corticosteroid withdrawal; 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; A primary care intervention to support switch from ICS containing regimen to non-ICS containing regimen in appropriate patients.
Active Comparator: Standard care; Patients will continue on their current recommended regimen including ICS.	Other: Standard care; Normal clinically indicated inhaled therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory Hospitalizations		1 year
Success of ICS withdrawal	Inhaled corticosteroid prescribing rates (number of patients receiving inhaled corticosteroid prescriptions at study completion divided by total number of COPD patients) and withdrawal rates (number of patients receiving inhaled corticosteroids prior to the intervention divided by the number of patients receiving inhaled corticosteroids following the intervention in each arm)	1 year
Time to the first moderate and severe exacerbation	First exacerbation or respiratory hospitalisation following the intervention	Time to first event (patients without an event censored at 1 year)
Oral corticosteroid use	Cumulative prescriptions for oral corticosteroids (excluding chronic low dose oral corticosteroids)	1 year
Antibiotic use	Cumulative prescriptions for oral antibiotics (excluding chronic low dose macrolides)	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of known ICS related adverse effects between groups	Pneumonia, fractures, cataracts and diabetes	1 year
Rates of ICS relapse	Proportion of patients undergoing ICS withdrawal who are subsequently restarted on inhaled corticosteroids within 12 months	1 year
Mortality	GRO based mortality data	1 year
Subgroup analyses in patients successfully withdrawing ICS	Frequency of moderate and severe exacerbations	1 year
Subgroup analyses based on baseline lung function for major endpoints	Frequency of moderate and severe exacerbations	1 year
Subgroup analyses based on baseline eosinophil count <300 cells/ul for major endpoints	Frequency of moderate and severe exacerbations	1 year

Collaborators and Investigators

• Sponsor: NHS Tayside
• Collaborators: NHS Fife
• Investigators: Principal Investigator: Philip M Short, NHS Tayside; Principal Investigator: Devesh Dhasmana, NHS FIFE; Study Director: Arlene Shaw, NHS Tayside; Study Director: Fiona Eastop, NHS Tayside

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: March 22, 2018
• First Submitted That Met QC Criteria: March 29, 2018
• First Posted (Actual): April 5, 2018

Study Record Updates

• Last Update Posted (Actual): March 20, 2023
• Last Update Submitted That Met QC Criteria: March 17, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Quality improvement; Inhaled corticosteroids; Cluster randomized Trial
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 2016RC23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be publically available through the health informatics centre, University o fDundee
• IPD Sharing Time Frame: To be determined
• IPD Sharing Access Criteria: Open
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No