Chronic Obstructive Pulmonary DiseaseTOWARDNCT03527927
sTep dOWn Inhalers in the reAl woRlD
A study testing Any LABA/LAMA in people with Chronic Obstructive Pulmonary Disease, run by Hywel Dda Health Board at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Any LABA/LAMA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 May 2017to 26 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Prince Philip Hospital
Llanelli, Carmarthenshire, SA148QF
About this study
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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Any LABA/LAMA
- Keywords
- COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Any LABA/LAMADrug
Also called Long acting beta agonist; Long acting muscarinic antagonist
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.
| Study group | Role | What they receive |
|---|---|---|
| LABA/LAMA inhaler | Experimental | 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. Receives: Drug: Any LABA/LAMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: At 12 months
Secondary outcomes (8)
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
Measured: 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
Measured: 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.
Measured: At 12 months
Lung function
Trend in FEV1
Measured: 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
Measured: Over 12 months
Costs
Comparison of total inhaler prescription costs
Measured: 12 months before and 12 months after enrollment
Inhaler device choice
Proportions of patients choosing each LABA+LAMA device and some reasons why
Measured: 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
Measured: Over 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start17 May 2017
- Primary completion26 Aug 2019
- Study completion26 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hywel Dda Health Board
- Sponsor type
- University, hospital or other
- Collaborators
- Swansea University
- Responsible party
- Sponsor
- Investigators
- Keir E Lewis, Prof, Study director, Hywel Dda University Health Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03527927
- Sponsor's protocol ID
- HywelDdaHB
- Acronym
- TOWARD
- Status last verified
- Oct 2023
- First submitted
- 18 Apr 2018
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- sTep dOWn Inhalers in the reAl woRlD
- ClinicalTrials.gov ID
- NCT03527927
- Acronym / sponsor ID
- TOWARD / HywelDdaHB
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Hywel Dda Health BoardUniversity, hospital or other
- Collaborators
- Swansea University
- Study start
- 17 May 2017 (actual)
- Primary completion
- 26 Aug 2019 (actual)
- Study completion
- 26 Aug 2019 (actual)
- First posted
- 17 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LABA/LAMA inhaler | Experimental | Drug: Any LABA/LAMAPatients 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. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Any LABA/LAMAAlso: Long acting beta agonist; Long acting muscarinic antagonistFollowing 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. | Drug | LABA/LAMA inhaler |
Primary outcome
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)
8 secondary outcomes
Moderate or severe exacerbations
Time frame: 12 months before and 12 months after enrollment
Exacerbations
Time frame: 12 months before and 12 months after enrollment
Restarting inhaled steroids
Time frame: At 12 months
Lung function
Time frame: Baseline, 4 weeks, 12 weeks, 26 weeks, 52 weeks
COPD assessment test (CAT)
Time frame: Over 12 months
Costs
Time frame: 12 months before and 12 months after enrollment
Inhaler device choice
Time frame: At enrollment
EQ-5D-3L
Time frame: Over 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keir E Lewis, Prof study director
Hywel Dda University Health Board
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Any LABA/LAMA in people with Chronic Obstructive Pulmonary Disease, run by Hywel Dda Health Board at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numbers maintained on dual bronchodilation (time frame: At 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2023.