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OpenTrials
Completed

NCT Number: NCT03527927

sTep dOWn Inhalers in the reAl woRlD

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prince Philip Hospital

Llanelli, Carmarthenshire, SA148QF, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Any LABA/LAMA

Drug

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

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. Restarting inhaled steroids

    Time frame: At 12 months

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

  4. Lung function

    Time frame: Baseline, 4 weeks, 12 weeks, 26 weeks, 52 weeks

    Trend in FEV1

  5. 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

  6. Costs

    Time frame: 12 months before and 12 months after enrollment

    Comparison of total inhaler prescription costs

  7. Inhaler device choice

    Time frame: At enrollment

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

  8. 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

Sponsors and collaborators

Lead sponsor

Hywel Dda Health Board

Other

Collaborators

  • Swansea University

Registry information

Acronym: TOWARD

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 17, 2018
Registry last updated
Oct 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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