sTep dOWn Inhalers in the reAl woRlD (TOWARD)

Hywel Dda Health Board

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Any LABA/LAMA

Study type: Interventional

Funder types: Other

Identifiers

NCT03527927

HywelDdaHB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 67 patients

Sex: All

Ages: 40 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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67 participants in 1 patient group

LABA/LAMA inhaler

Experimental group

Description:

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.

Treatment:

Drug: Any LABA/LAMA