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


- candidate number10164
- NTR NumberNTR2989
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-jul-2011
- Secondary IDsP11-26 / NL37382.044.11; METC / CCMO
- Public TitleOnderzoek naar gebruiksgemak van, voorkeur voor, en tevredenheid met twee verschillende inhalatoren bij patiŽnten met astma of COPD.
- Scientific TitleStudy evaluating ease of use, preference and satisfaction of two different Fluticason/salmeterol inhalers in asthma or COPD COPD patients.
- ACRONYMDiskus versus Elpenhaler
- hypothesisDiskus is superior to Elpenhaler with regard to ease of use, preference and satisfaction.
- Healt Condition(s) or Problem(s) studiedAsthma, COPD, Lung emphysema, Chronic bronchitis
- Inclusion criteria1. 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 criteria1. 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 receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-aug-2011
- planned closingdate15-dec-2011
- Target number of participants110
- InterventionsRandomized 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 outcomePercentage of patients doing at least 1 critical error using each device after reading the insert.
- Secondary outcome1. 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.
- TimepointsThe study consists of 1 visit.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. dr. J. Palen, van der
- CONTACT for SCIENTIFIC QUERIESProf. dr. J. Palen, van der
- Sponsor/Initiator Medisch Spectrum Twente
- Funding
(Source(s) of Monetary or Material Support)
GlaxoSmithKline
- PublicationsN/A
- Brief summaryStudy 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 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.

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, patientís preference and satisfaction will be evaluated using the inhaler devices with placebo.
- Main changes (audit trail)
- RECORD15-jul-2011 - 26-jul-2011


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