To assess the percentage of COPD and asthma patients correctly (all critical items correct) using the Accuhaler/Diskus vs Elpenhaler inhaler devices after reading the package insert. Also satisfaction with and preference for an inhaler will be…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The percentage of COPD and asthma patients correctly (all critical items
correct) using the Accuhaler/Diskus vs Elpenhaler inhaler devices after reading
the package insert
Secondary outcome
To assess patient*s overall satisfaction with each device.
To assess the number of instructions needed for correct use of each device
To assess the patient*s overall preference for a device
Background summary
Inhalation therapy is the main method of administering medication to patients
with asthma or COPD. It is important that patients are instructed in the use of
their inhalers. this study investigates how easy it is to instruct and use two
different inhalers and which inhaler patients prefer. An inhaler that is easy
to use will lead to a better inhalation technique and fewer inhalation errors.
This, in turn, will lead to a better effectiveness of the medication. A better
effectiveness, coupled with a stronger preference for an inhaler will lead to
better therapy adherence.
Study objective
To assess the percentage of COPD and asthma patients correctly (all critical
items correct) using the Accuhaler/Diskus vs Elpenhaler inhaler devices after
reading the package insert. Also satisfaction with and preference for an
inhaler will be assessed as well as the number of instructions needed to reach
an adequate inhalation technique.
Study design
Multi-center randomised cross-over study
Intervention
Patients will be asked to demonstrate their proficiency with two different
inhalers, after reading the package insert, and, if errors are observed, after
up to three instructions.
Study burden and risks
The burden exists of demonstrating the use of two inhalers after reading the
package insert, and possible follow-up instructions. There is no risk
associated with the study.
Haaksbergerstraat 55
7513 ER Enschede
NL
Haaksbergerstraat 55
7513 ER Enschede
NL
Listed location countries
Age
Inclusion criteria
1. Age > 40 with stable COPD or asthma
2. Patients naïve to the study inhalers, Accuhaler/Diskus and Elpenhaler for at least 1 year
3. Patients agreeing on participating and signing the Informed Consent Form
Exclusion criteria
1. Patients currently participating in another randomised clinical trial
2. Patients with body malformations or diseases affecting coordination and/or motor system
3. Patients unable to read product package instructions and answer patient reported questionnaires
Design
Recruitment
Medical products/devices used
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 | NL37382.044.11 |