An interventional study of Any LABA/LAMA in Chronic Obstructive Pulmonary Disease, sponsored by Hywel Dda Health Board. Completed at 1 site in United Kingdom. Open to participants aged 40 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-10-25.
Sponsored by Hywel Dda Health Board · Not applicable, Interventional, and Treatment
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.
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.
2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.
This study's enrollment of 67 is close to the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.
Browse Lung Diseases, Obstructive studies →Hywel Dda Health Board is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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)
Time frame: At 12 months
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
Time frame: 12 months before and 12 months after enrollment
Exacerbations
Comparison of the number of moderate and severe exacerbations in those on LABA+LAMA over 52 weeks compared with those continuing triple therapy
Time frame: 12 months before and 12 months after enrollment
Restarting inhaled steroids
Proportion of patients requiring restarting ICS (on the discretion of their clinician) at each visit.
Time frame: At 12 months
Lung function
Trend in FEV1
Time frame: Baseline, 4 weeks, 12 weeks, 26 weeks, 52 weeks
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
Time frame: Over 12 months
Costs
Comparison of total inhaler prescription costs
Time frame: 12 months before and 12 months after enrollment
Inhaler device choice
Proportions of patients choosing each LABA+LAMA device and some reasons why
Time frame: At enrollment
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
Time frame: Over 12 months
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This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Hywel Dda Health Board