A randomized, open-label, cross-over, placebo-device study investigating critical and over all errors, training/teaching time, and preference attributes of the ELLIPTA dry powder Inhaler (DPI) as compared to HandiHaler DPI used in combination with either DISKUS DPI or Turbuhaler DPI, in adult patients with Chronic Obstructive Pulmonary Disease (COPD) (study 206215)
- Conditions
- chronic obstructive airways disease (COPD)10006436
- Registration Number
- NL-OMON45492
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 125
* *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.
* 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The percentage of subjects making at least one critical error after reading the<br /><br>PIL(s).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Percentage of subjects making at least one critical error after the first /<br /><br>second instruction, percentage of subjects making at least one overall error<br /><br>after reading the PIL(s) / after the 1st instruction / after the 2nd<br /><br>instruction, number of instructions (0, 1 or 2 times) needed to demonstrate<br /><br>correct inhaler use, amount of time taken to demonstrate correct inhaler use<br /><br>(T1+T2), to read the PIL and demonstrate correct inhaler use (T1), to be given<br /><br>instruction and to demonstrate correct inhaler use (T2), Treatment preference<br /><br>for: number of steps required to take COPD medication and overall treatment<br /><br>preference.</p><br>