asthma astma COPD chronische bronchitis longemfyseem
Conditions
Interventions
Randomized cross-over multicentre design with one measurement moment
both devices will contain only placebo.
The subjects will be randomly distributed into 2 groups, determining the sequence of use of each inhaler: patients in Group A will use Accuhaler/Diskus device
Sponsors
Medisch Spectrum Twente, Enschede
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult male or female patients aged > 40 with stable COPD or asthma; 2. Patients have to be 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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients doing at least 1 critical error using each device after reading the insert. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of patients doing at least 1 critical error using each device after the first instruction by the trainer; 2. Number of instructions needed; 3. Overall satisfaction with the device; 4. The percentage of patients who prefer Accuhaler/Diskus. | — |
Contacts
Public ContactJ. Palen, van der
Medisch Spectrum Twente, P.O. Box 50000
Outcome results
None listed