Primary:To compare the number of critical errors made by COPD patients, after a subject has read the respective patient information leaflet(s) (PIL), for each treatment option tested.Secondary:Number of critical errors made after instruction from…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The percentage of subjects making at least one critical error after reading the
PIL(s).
Secondary outcome
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.
Background summary
Currently, subjects requiring triple therapy can be prescribed ICS/LABA and
LAMA in separate inhalers. The specific ICS/LABA and LAMA prescribed determine
whether the inhaler types (and thereby the inhalation techniques) and the
dosing regimens are similar or different. Use of different inhaler types with
different inhalation techniques and dosing regimens can add to treatment
complexity, and also increase the potential for errors in inhaler use that
reduce or preclude drug delivery to the site of action in the lungs. Fixed-dose
combination inhalers that minimize the number of inhalers required would
simplify treatment, improve adherence, reduce errors in inhaler use, and
potentially lead to better treatment outcomes.
This study is designed to assess the benefits of delivering triple therapy
using one single ELLIPTA DPI (Dry Powder Inhaler) versus delivering triple
therapy using two different types of inhalers to patients with COPD. It will
assess the proportion of COPD subjects who make critical errors when using one
single ELLIPTA DPI versus those using combinations of commercially available
and commonly used DPIs: DISKUS used in combination with HandiHaler, or
Turbuhaler used in combination with HandiHaler. This study would also assess
training/teaching time and preference attributes for closed triple therapy as
compared to the open triple therapy.
Study objective
Primary:
To compare the number of critical errors made by COPD patients, after a subject
has read the respective patient information leaflet(s) (PIL), for each
treatment option tested.
Secondary:
Number of critical errors made after instruction from the healthcare provider,
number of (non)critical errors after reading the PIL(S) or after Instruction,
number of instructions needed to demonstrate correct inhaler use,
Training/Teaching Time required to demonstrate correct inhaler use, patient
preference.
Study design
Randomized, open-label, placebo-device, cross-over study, with a 2x2 complete
block design.
Sub-study 1: ELLIPTA DPI versus DISKUS-HandiHaler DPI combination.
Sub-study 2: ELLIPTA DPI versus Turbuhaler-HandiHaler DPI combination.
Allocation to sub-studies: based on the type(s) of inhaler used in the past 2
years.
Randomization for treatment sequence.
Each sub-study may run independently or in parallel of the other sub study.
Approximately 144 evaluable complete subjects.
Intervention
Placebo-inhalations from 3 inhalers.
Study burden and risks
Risk: Adverse events of the placebo ingredients. No active study medication.
Burden:
1 visit, approx. 2 hours duration.
Up to 3 attempts to demonstrate the correct use of each of the 3 inhalers:
Attempt 1
Read the PIL of the inhaler. Demonstrate how to use that inhaler. Any errors
will be recorded. If no errors: continue with next inhaler.
Attempt 2
In case of error(s) in attempt 1, study staff instruct the subject in correct
use of the inhaler. Demonstrate how to use that inhaler. Any errors will be
recorded. If no errors: continue with next inhaler.
Attempt 3
In case of error(s) in attempt 2, study staff instruct the subject again in
correct use of the inhaler. Demonstrate how to use that inhaler. Any errors
will be recorded. Always (with or without errors): continue with next inhaler.
Patient preference (2 questions).
Huis ter Heideweg 62
Zeist 3705 LZ
NL
Huis ter Heideweg 62
Zeist 3705 LZ
NL
Listed location countries
Age
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
* 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL59648.100.16 |
| Other | www.gskclinicalstudyregister.com (206215) |