sTep dOWn Inhalers in the reAl woRlD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-17

Study Completion Date

2019-08-26

Brief Summary

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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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Detailed Description

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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

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Any LABA/LAMA

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Long acting beta agonist; Long acting muscarinic antagonist

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No