sTep dOWn Inhalers in the reAl woRlD

Study Overview
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Brief Summary
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To establish the feasibility of stopping inhaled steroids and switching or maintaining dual bronchodilation in one visit - in the real world, for people with COPD.

Detailed Description
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COPD patients prescribed a combination of any inhaled corticosteroid (ICS), long acting beta agonist (LABA) and long acting muscarinic antagonist (LAMA) will be switched to a single LABA/LAMA combination inhaler, stopping their ICS. They will be followed up for 12 months. Participants are shown the four currently available LABA/LAMA combination inhalers and instructed on their use. The clinical specialist will use standard prompts in an effort to demonstrate the inhalers in an unbiased way. The participants will choose: Ultibro® (Breezhaler device) or Duaklir® (Genuair device) or Anoro® (Ellipta device) or Spiolto® (Respimat device) and they will be prescribed the inhaler of their choice provided they can demonstrate effective use. Patients will be reviewed 4, 12, 26 and at 52 weeks after switching with clinical outcomes measured at these points. As this is a real-world open study the patients and GPs are instructed that treatments can be changed at any point as clinically indicated, including restarting an ICS.

Official Title
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sTep dOWn Inhalers in the reAl woRlD

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: Any LABA/LAMA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: GP diagnosis of COPD Post bronchodilator FEV1/FVC ratio <70% with FEV1<80% predicted Current or ex smoker equal or greater than 10 pack years Taking an ICS, LABA & LAMA Exclusion Criteria: Unable or unwilling to sign informed consent Any previous or current diagnosis of asthma Any features of asthma or large variability in symptoms History of atopy Any previous blood eosinophil count >600mm3 A moderate or severe exacerbation of COPD (needing systemic glucocorticosteroids or hospital admission for >24 hours) within the last 6 weeks Life expectancy < 1 year

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LABA/LAMA inhaler<br>Patients on a combination of inhaled corticosteroid (ICS), long acting beta agonist (LABA) and long acting muscarinic antagonist (LAMA) will be taken off their current ICS/LABA/LAMA combination inhalers and will commence on a single LABA/LAMA inhaler (any LABA/LAMA) of their choice. | Drug: Any LABA/LAMA<br>* Following consent, patients will be taken off their current ICS/LABA/LAMA combination inhalers and shown 4 single inhaler LABA/LAMA devices and asked to choose a preferred device to use, provided they can demonstrate effective use.<br>* Other names: Long acting beta agonist; Long acting muscarinic antagonist;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numbers maintained on dual bronchodilation | The proportion of patients with stable COPD who can be successfully switched from triple inhaled therapy (ICS+LABA+LAMA in any combination of inhalers) to dual inhaled bronchodilator therapy (LABA+LAMA) | At 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Moderate or severe exacerbations | Comparison of the number of moderate and severe exacerbations in those on LABA+LAMA over 52 weeks compared with their previous 52 weeks | 12 months before and 12 months after enrollment | 
| Exacerbations | Comparison of the number of moderate and severe exacerbations in those on LABA+LAMA over 52 weeks compared with those continuing triple therapy | 12 months before and 12 months after enrollment | 
| Restarting inhaled steroids | Proportion of patients requiring restarting ICS (on the discretion of their clinician) at each visit. | At 12 months | 
| Lung function | Trend in FEV1 | Baseline, 4 weeks, 12 weeks, 26 weeks, 52 weeks | 
| COPD assessment test (CAT) | Changes in total CAT score (range 0-40), higher score indicates worse outcome) from baseline, at 4 weeks, 12 weeks, 26 weeks and 52 weeks | Over 12 months | 
| Costs | Comparison of total inhaler prescription costs | 12 months before and 12 months after enrollment | 
| Inhaler device choice | Proportions of patients choosing each LABA+LAMA device and some reasons why | At enrollment | 
| EQ-5D-3L | General quality of life visual analogue scale from 0-100, 0 indicates worse imaginable health and 100 best imaginable health. Score reported at baseline, 4 weeks, 12 weeks, 26 weeks and 52 weeks | Over 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD