No registrations found.
ID
Source
Brief title
Health condition
asthma
astma
COPD
chronische bronchitis
longemfyseem
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percentage of patients doing at least 1 critical error using each device after reading the insert.
Secondary outcome
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.
Background summary
Study evaluating ease of use, preference and satisfaction of two different Fluticason/salmeterol inhalers in asthma and COPD patients.
Primary Objective:
To compare 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 Objectives:
1. To compare patient’s overall satisfaction with each device;
2. To compare the number of instructions needed for correct use of each device;
3. To compare the patient’s overall preference for a device.
Study Design:
Randomized cross-over multinational and multicentre design with one measurement moment; both devices will contain only placebo.
Study Population:
A total of 110 subjects, 55 subjects per sequence, will be randomized.
Evaluations:
Correct use, patient’s preference and satisfaction will be evaluated using the inhaler devices with placebo.
Study objective
Diskus is superior to Elpenhaler with regard to ease of use, preference and satisfaction.
Study design
The study consists of 1 visit.
Intervention
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 first and secondly the Elpenhaler. Patients in Group B will use Elpenhaler first followed by Accuhaler/Diskus.
The study consists of 1 visit. First, the patient will be asked to read the written package insert of the first device according to the sequence of Group A or B, which is followed by a first attempt. If any mistake in inhalation is made patients will be instructed by a trainer in the device (up to 4 attempts).
P.O. Box 50000
J. Palen, van der
Enschede 7500 KA
The Netherlands
+31 (0)53 4872023
P.O. Box 50000
J. Palen, van der
Enschede 7500 KA
The Netherlands
+31 (0)53 4872023
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
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
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 |
|---|---|
| NTR-new | NL2847 |
| NTR-old | NTR2989 |
| Other | METC / CCMO : P11-26 / NL37382.044.11; |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |