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TOWARD: sTep dOWn Inhalers in the reAl woRlD

Sponsor
Hywel Dda Health Board (Other)
Overall Status
Completed
CT.gov ID
NCT03527927
Collaborator
Swansea University (Other)
67
Enrollment
1
Location
1
Arm
39.5
Actual Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Any LABA/LAMA
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
67 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
sTep dOWn Inhalers in the reAl woRlD
Actual Study Start Date :
May 17, 2017
Actual Primary Completion Date :
Aug 31, 2020
Actual Study Completion Date :
Aug 31, 2020

Arms and Interventions

Arm Intervention/Treatment
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.

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.
Other Names:
  • Long acting beta agonist; Long acting muscarinic antagonist

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Numbers maintained on dual bronchodilation [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 Outcome Measures

    1. Moderate or severe exacerbations [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

    2. Exacerbations [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

    3. Restarting inhaled steroids [At 12 months]

      Proportion of patients requiring restarting ICS (on the discretion of their clinician) at each visit.

    4. Lung function [Baseline, 4 weeks, 12 weeks, 26 weeks, 52 weeks]

      Trend in FEV1

    5. COPD assessment test (CAT) [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

    6. Costs [12 months before and 12 months after enrollment]

      Comparison of total inhaler prescription costs

    7. Inhaler device choice [At enrollment]

      Proportions of patients choosing each LABA+LAMA device and some reasons why

    8. EQ-5D-3L [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Prince Philip Hospital Llanelli Carmarthenshire United Kingdom SA148QF

    Sponsors and Collaborators

    • Hywel Dda Health Board
    • Swansea University

    Investigators

    • Study Director: Keir E Lewis, Prof, Hywel Dda University Health Board

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr Keir Lewis, Professor of Respiratory Medicine, Swansea University and Hon Consultant, Hywel Dda Health Board, Wales, UK, Hywel Dda Health Board
    ClinicalTrials.gov Identifier:
    NCT03527927
    Other Study ID Numbers:
    • HywelDdaHB
    First Posted:
    May 17, 2018
    Last Update Posted:
    Aug 3, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dr Keir Lewis, Professor of Respiratory Medicine, Swansea University and Hon Consultant, Hywel Dda Health Board, Wales, UK, Hywel Dda Health Board
    COPD
    Additional relevant MeSH terms:
    Lung Diseases, Obstructive
    Pulmonary Disease, Chronic Obstructive
    Muscarinic Antagonists

    Study Results

    No Results Posted as of Aug 3, 2022