Onderzoek naar gebruiksgemak van, voorkeur voor, en tevredenheid met twee verschillende inhalatoren bij patiënten met astma of COPD.

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.

Diskus is superior to Elpenhaler with regard to ease of use, preference and satisfaction.

The study consists of 1 visit.

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).