to assess patient's overall preference for the two inhaler devices in COPD patients after 2 weeks of dialy practice.
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary variable is the percentage of patients who prefer the new inhaler
at visit 2.
Secondary outcome
The secundary outcome
ease of use
convenience
ease of learning to use
ease of holding
ease of operating
ease of preparation of the dose
feedback to indicate correct inhalation
dosage
Background summary
Because an inadequate technique reduces the effect of inhalation, the
development of an easy-to-use inhaler device that delivers effectively the drug
to the lungs, is as important as the development of an efficacious and safe
drug itself. It is of clinical interest to run this study to evaluate patient's
preferrence, satisfaction and ease of use, on the use of inhalers, in COPD
diagnosed patients in order to gain better knowledge of how these patients
perform on the use of these inhalers and the potential benefits the results
migt bring.
Study objective
to assess patient's overall preference for the two inhaler devices in COPD
patients after 2 weeks of dialy practice.
Study design
Randomized, cross-over multinational and multicentre design with two
measurement moments, both devices will contain only placebo
Intervention
Not applicable
Study burden and risks
Two visits and during the second visit the subjects will be asked to fill out a
questionnaire. In between the two visits, the subjects will be using two
additional inhalers dialy and will be fillling out a patient diary.
Rda. General Mitre, 151
08022 Barcelona
ES
Rda. General Mitre, 151
08022 Barcelona
ES
Listed location countries
Age
Inclusion criteria
male or female aged > 39 years
stable COPD
naïve to the study inhalers
Exclusion criteria
clinical significant disease, particular body malformations of diseases affecting coordination and/or motor system (e.g. malformations or lack of upper extremities, Any disease that may affect the proper handling of the inhalers (Wilson*s disease, Stroke, Parkinson, Huntington*s Chorea...) ;unable to read product package instructions and to answer questionnaires
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| CCMO | NL35663.044.11 |