chronic obstructive airways disease (COPD)
Conditions
Interventions
Placebo-inhalations from 3 inhalers.
Sponsors
GlaxoSmithKline
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * *40 years of age. * COPD in accordance with the definition by the European Respiratory Society. * Currently receiving maintenance therapy with a fixed dose combination of a long-acting beta 2-agonist and inhaled corticosteroid for at least 4 weeks, ± long-acting anti-cholinergic. * Current or former cigarette smokers with a >10 pack-year smoking history. * Males or females who are not pregnant or not lactating.
Exclusion criteria
Exclusion criteria: * Asthma. * Use of the ELLIPTA inhaler in the past 24 months. * Use of any capsule system inhaler in the past 24 months, examples see protocol page 16). * Use in the past 24 months of DISKUS (for sub-study 1) or Turbuhaler (for sub-study 2). * History of hypersensitivity to lactose, magnesium stearate. History of severe milk protein allergy that, in the opinion of the study physician, contraindicates participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of subjects making at least one critical error after reading the PIL(s). | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects making at least one critical error after the first / second instruction, percentage of subjects making at least one overall error after reading the PIL(s) / after the 1st instruction / after the 2nd instruction, number of instructions (0, 1 or 2 times) needed to demonstrate correct inhaler use, amount of time taken to demonstrate correct inhaler use (T1+T2), to read the PIL and demonstrate correct inhaler use (T1), to be given instruction and to demonstrate correct inhaler use (T2), Treatment preference for: number of steps required to take COPD medication and overall treatment preference. | — |
Countries
Netherlands
Outcome results
None listed