sTep dOWn Inhalers in the reAl woRlD

Chronic Obstructive Pulmonary Disease Clinical Trial

— TOWARD  

Official title:

sTep dOWn Inhalers in the reAl woRlD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03527927
• Other study ID #: HywelDdaHB
• Status: Completed
• Phase: N/A
• Start date: May 17, 2017
• Est. completion date: August 26, 2019

Study information

• Verified date: October 2023
• Source: Hywel Dda Health Board
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: August 26, 2019
• Est. primary completion date: August 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United Kingdom	Prince Philip Hospital	Llanelli	Carmarthenshire

Sponsors (2)

Lead Sponsor	Collaborator
Hywel Dda Health Board	Swansea University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	12 months before and 12 months after enrollment
Secondary	Exacerbations	Comparison of the number of moderate and severe exacerbations in those on LABA+LAMA over 52 weeks compared with those continuing triple therapy	12 months before and 12 months after enrollment
Secondary	Restarting inhaled steroids	Proportion of patients requiring restarting ICS (on the discretion of their clinician) at each visit.	At 12 months
Secondary	Lung function	Trend in FEV1	Baseline, 4 weeks, 12 weeks, 26 weeks, 52 weeks
Secondary	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	Over 12 months
Secondary	Costs	Comparison of total inhaler prescription costs	12 months before and 12 months after enrollment
Secondary	Inhaler device choice	Proportions of patients choosing each LABA+LAMA device and some reasons why	At enrollment
Secondary	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	Over 12 months