|- candidate number||10164|
|- NTR Number||NTR2989|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||15-jul-2011|
|- Secondary IDs||P11-26 / NL37382.044.11; METC / CCMO|
|- Public Title||Onderzoek naar gebruiksgemak van, voorkeur voor, en tevredenheid met twee verschillende inhalatoren bij patiŽnten met astma of COPD.|
|- Scientific Title||Study evaluating ease of use, preference and satisfaction of two different Fluticason/salmeterol inhalers in asthma or COPD COPD patients.|
|- ACRONYM||Diskus versus Elpenhaler|
|- hypothesis||Diskus is superior to Elpenhaler with regard to ease of use, preference and satisfaction.|
|- Healt Condition(s) or Problem(s) studied||Asthma, COPD, Lung emphysema, Chronic bronchitis|
|- Inclusion criteria||1. Adult male or female patients aged > 40 with stable COPD or asthma;|
2. Patients have to be naÔve 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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||15-aug-2011|
|- planned closingdate||15-dec-2011|
|- Target number of participants||110|
|- 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 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).
|- 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.
|- Timepoints||The study consists of 1 visit.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Prof. dr. J. Palen, van der|
|- CONTACT for SCIENTIFIC QUERIES||Prof. dr. J. Palen, van der|
|- Sponsor/Initiator ||Medisch Spectrum Twente|
(Source(s) of Monetary or Material Support)
|- Brief summary||Study evaluating ease of use, preference and satisfaction of two different Fluticason/salmeterol inhalers in asthma and COPD patients.
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.
1. To compare patientís overall satisfaction with each device;
2. To compare the number of instructions needed for correct use of each device;
3. To compare the patientís overall preference for a device.
Randomized cross-over multinational and multicentre design with one measurement moment; both devices will contain only placebo.
A total of 110 subjects, 55 subjects per sequence, will be randomized.
Correct use, patientís preference and satisfaction will be evaluated using the inhaler devices with placebo.
|- Main changes (audit trail)|
|- RECORD||15-jul-2011 - 26-jul-2011|