NCT03527927

sTep dOWn Inhalers in the reAl woRlD

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Hywel Dda Health Board · Academic / Other
• Sex: All
• Age: 40 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-05-17
• Primary completion: 2019-08-26
• Completion: 2019-08-26
• First posted: 2018-05-17
• Last updated: 2023-10-25

Locations

1 site across 1 country: United Kingdom