sTep dOWn Inhalers in the reAl woRlD (TOWARD)

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 Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: Any LABA/LAMA

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 Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Carmarthenshire
    • Llanelli, Carmarthenshire, United Kingdom, SA148QF
      • Prince Philip Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hywel Dda Health Board
• Collaborators: Swansea University
• Investigators: Study Director: Keir E Lewis, Prof, Hywel Dda University Health Board

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2017
• Primary Completion (Actual): August 26, 2019
• Study Completion (Actual): August 26, 2019

Study Registration Dates

• First Submitted: April 18, 2018
• First Submitted That Met QC Criteria: May 16, 2018
• First Posted (Actual): May 17, 2018

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: COPD
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Chronic Disease; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Antagonists; Cholinergic Agents; Muscarinic Antagonists
• Other Study ID Numbers: HywelDdaHB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No