Clinical trial NCT03527927: sTep dOWn Inhalers in the reAl woRlD
Official title: sTep dOWn Inhalers in the reAl woRlD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Lead sponsor: Hywel Dda Health Board
Sponsor class: OTHER
Collaborators: name: Swansea University
First posted: 2018-05-17
Enrollment: 67
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Numbers maintained on dual bronchodilation
timeFrame: At 12 months
Secondary outcomes:
measure: Moderate or severe exacerbations
timeFrame: 12 months before and 12 months after enrollment
measure: Exacerbations
timeFrame: 12 months before and 12 months after enrollment
measure: Restarting inhaled steroids
timeFrame: At 12 months
measure: Lung function
timeFrame: Baseline, 4 weeks, 12 weeks, 26 weeks, 52 weeks
measure: COPD assessment test (CAT)
timeFrame: Over 12 months
measure: Costs
timeFrame: 12 months before and 12 months after enrollment
measure: Inhaler device choice
timeFrame: At enrollment
measure: EQ-5D-3L
timeFrame: Over 12 months
Other outcomes:
Locations:
city: Llanelli
country: United Kingdom
facility: Prince Philip Hospital
state: Carmarthenshire
Study officials:
affiliation: Hywel Dda University Health Board
name: Keir E Lewis, Prof
role: STUDY_DIRECTOR
References: