Clinical trial NCT03489746: Steroid Withdrawal Intervention in Fife and Tayside
Official title: A Cluster Randomised Trial of Medication Review and Withdrawal of Inappropriate Inhaled Corticosteroid Treatment in Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Inhaled corticosteroids
Quality improvement
Cluster randomized Trial
Lead sponsor: NHS Tayside
Sponsor class: OTHER_GOV
Collaborators: name: NHS Fife
First posted: 2018-04-05
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized controlled trial at practice level
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Frequency of moderate and severe exacerbations of COPD
timeFrame: 1 year
Secondary outcomes:
measure: Respiratory Hospitalizations
timeFrame: 1 year
measure: Success of ICS withdrawal
timeFrame: 1 year
measure: Time to the first moderate and severe exacerbation
timeFrame: Time to first event (patients without an event censored at 1 year)
measure: Oral corticosteroid use
timeFrame: 1 year
measure: Antibiotic use
timeFrame: 1 year
Other outcomes:
measure: Rates of known ICS related adverse effects between groups
timeFrame: 1 year
measure: Rates of ICS relapse
timeFrame: 1 year
measure: Mortality
timeFrame: 1 year
measure: Subgroup analyses in patients successfully withdrawing ICS
timeFrame: 1 year
measure: Subgroup analyses based on baseline lung function for major endpoints
timeFrame: 1 year
measure: Subgroup analyses based on baseline eosinophil count <300 cells/ul for major endpoints
timeFrame: 1 year
Locations:
city: Dundee
country: United Kingdom
facility: NHS Tayside
state: Perthshire
city: Kirkcaldy
country: United Kingdom
facility: NHS FIfe
Study officials:
affiliation: NHS Tayside
name: Philip M Short
role: PRINCIPAL_INVESTIGATOR
affiliation: NHS Fife
name: Devesh Dhasmana
role: PRINCIPAL_INVESTIGATOR
affiliation: NHS Tayside
name: Arlene Shaw
role: STUDY_DIRECTOR
affiliation: NHS Tayside
name: Fiona Eastop
role: STUDY_DIRECTOR
References: