sTep dOWn Inhalers in the reAl woRlD

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 31, 2019

Detailed Description

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.

Interventions

  • Drug: Any LABA/LAMA
    • 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.

Arms, Groups and Cohorts

  • Experimental: LABA/LAMA inhaler
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Numbers maintained on dual bronchodilation
    • Time Frame: At 12 months
    • 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)

Secondary Measures

  • Moderate or severe exacerbations
    • Time Frame: 12 months before and 12 months after enrollment
    • Comparison of the number of moderate and severe exacerbations in those on LABA+LAMA over 52 weeks compared with their previous 52 weeks
  • Exacerbations
    • Time Frame: 12 months before and 12 months after enrollment
    • Comparison of the number of moderate and severe exacerbations in those on LABA+LAMA over 52 weeks compared with those continuing triple therapy
  • Restarting inhaled steroids
    • Time Frame: At 12 months
    • Proportion of patients requiring restarting ICS (on the discretion of their clinician) at each visit.
  • Lung function
    • Time Frame: Baseline, 4 weeks, 12 weeks, 26 weeks, 52 weeks
    • Trend in FEV1
  • COPD assessment test (CAT)
    • Time Frame: Over 12 months
    • 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
  • Costs
    • Time Frame: 12 months before and 12 months after enrollment
    • Comparison of total inhaler prescription costs
  • Inhaler device choice
    • Time Frame: At enrollment
    • Proportions of patients choosing each LABA+LAMA device and some reasons why
  • EQ-5D-3L
    • Time Frame: Over 12 months
    • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hywel Dda Health Board
  • Collaborator
    • Swansea University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr Keir Lewis, Professor of Respiratory Medicine, Swansea University and Hon Consultant, Hywel Dda Health Board, Wales, UK – Hywel Dda Health Board
  • Overall Official(s)
    • Keir E Lewis, Prof, Study Director, Hywel Dda University Health Board
  • Overall Contact(s)
    • Sarah E Rees, 01554 756567, sarah.rees7@wales.nhs.uk

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