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sTep dOWn Inhalers in the reAl woRlD (TOWARD)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Any LABA/LAMA
Sponsored by
Hywel Dda Health Board
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Prince Philip Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LABA/LAMA inhaler

Arm Description

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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
Exacerbations
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
Proportion of patients requiring restarting ICS (on the discretion of their clinician) at each visit.
Lung function
Trend in FEV1
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
Costs
Comparison of total inhaler prescription costs
Inhaler device choice
Proportions of patients choosing each LABA+LAMA device and some reasons why
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

Full Information

First Posted
April 18, 2018
Last Updated
October 23, 2023
Sponsor
Hywel Dda Health Board
Collaborators
Swansea University
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1. Study Identification

Unique Protocol Identification Number
NCT03527927
Brief Title
sTep dOWn Inhalers in the reAl woRlD
Acronym
TOWARD
Official Title
sTep dOWn Inhalers in the reAl woRlD
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
May 17, 2017 (Actual)
Primary Completion Date
August 26, 2019 (Actual)
Study Completion Date
August 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hywel Dda Health Board
Collaborators
Swansea University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LABA/LAMA inhaler
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Any LABA/LAMA
Other Intervention Name(s)
Long acting beta agonist; Long acting muscarinic antagonist
Intervention Description
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.
Primary Outcome Measure Information:
Title
Numbers maintained on dual bronchodilation
Description
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)
Time Frame
At 12 months
Secondary Outcome Measure Information:
Title
Moderate or severe exacerbations
Description
Comparison of the number of moderate and severe exacerbations in those on LABA+LAMA over 52 weeks compared with their previous 52 weeks
Time Frame
12 months before and 12 months after enrollment
Title
Exacerbations
Description
Comparison of the number of moderate and severe exacerbations in those on LABA+LAMA over 52 weeks compared with those continuing triple therapy
Time Frame
12 months before and 12 months after enrollment
Title
Restarting inhaled steroids
Description
Proportion of patients requiring restarting ICS (on the discretion of their clinician) at each visit.
Time Frame
At 12 months
Title
Lung function
Description
Trend in FEV1
Time Frame
Baseline, 4 weeks, 12 weeks, 26 weeks, 52 weeks
Title
COPD assessment test (CAT)
Description
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
Time Frame
Over 12 months
Title
Costs
Description
Comparison of total inhaler prescription costs
Time Frame
12 months before and 12 months after enrollment
Title
Inhaler device choice
Description
Proportions of patients choosing each LABA+LAMA device and some reasons why
Time Frame
At enrollment
Title
EQ-5D-3L
Description
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
Time Frame
Over 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keir E Lewis, Prof
Organizational Affiliation
Hywel Dda University Health Board
Official's Role
Study Director
Facility Information:
Facility Name
Prince Philip Hospital
City
Llanelli
State/Province
Carmarthenshire
ZIP/Postal Code
SA148QF
Country
United Kingdom

12. IPD Sharing Statement

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