sTep dOWn Inhalers in the reAl woRlD

NCT03527927 | Completed

• 1 other identifier: HywelDdaHB
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Moderate or severe exacerbations

  12 months before and 12 months after enrollment

• Exacerbations

  12 months before and 12 months after enrollment

• Restarting inhaled steroids

  At 12 months

• Lung function

  Baseline, 4 weeks, 12 weeks, 26 weeks, 52 weeks

• COPD assessment test (CAT)

  Over 12 months

Study Arms (1)

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.

Drug: Any LABA/LAMA

Interventions

Any LABA/LAMA 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.

Also known as: Long acting beta agonist; Long acting muscarinic antagonist

LABA/LAMA inhaler

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hywel Dda Health Board: lead
• Swansea University: collaborator

Study Sites (1)

Prince Philip Hospital

Llanelli, Carmarthenshire, SA148QF, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Keir E Lewis, Prof

  Hywel Dda University Health Board

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2018
• First Posted: May 17, 2018
• Study Start: May 17, 2017
• Primary Completion: August 26, 2019
• Study Completion: August 26, 2019
• Last Updated: October 25, 2023

Record last verified: 2023-10

Locations

GB (1)