Preference study: Genuair® (Pressair™) vs Breezhaler® (Neohaler™) inhalers in patients with COPD
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
128
Inhaler with placebo only. Once daily, for 14 days.
Inhaler with placebo only. Once daily, for 14 days.
Almirall investigative site 2
Berlin, Germany
Almirall investigative site 1
Munich, Germany
Almirall investigative site 3
Barcelona, Spain
Almirall investigative site 4
Palma de Mallorca, Spain
Percentage of patients who prefer Genuair® (Pressair™) versus Breezhaler® (Neohaler™) at Visit 2
Patients will be asked to answer which device they prefer after 2 weeks of daily practice recorded via PASAPQ (Patient Satisfaction and Preference Questionnaire) a self-administered, 15-item measure of respiratory inhalation device satisfaction and preference. The PASAPQ 15-item instrument includes 13 satisfaction items \[using a Likert-type scale from 1 (very dissatisfied) to 7 (very satisfied)\], a preference item, and a question on willingness to continue using the device.
Time frame: 14 Days
Mean for the overall satisfaction score with Genuair® (Pressair™) and Breezhaler® (Neohaler™) at Visit 2
Patients will be asked to rate the overall satisfaction with each device using a Likert-type scale (from 1 \[very dissatisfied\] to 7 \[very satisfied\]) after 2 weeks of daily practice recorded via PASAPQ (Patient Satisfaction and Preference Questionnaire) a self-administered, 15-item measure of respiratory inhalation device satisfaction and preference. The PASAPQ 15-item instrument includes 13 satisfaction items \[using a Likert-type scale from 1 (very dissatisfied) to 7 (very satisfied)\], a preference item, and a question on willingness to continue using the device.
Time frame: 14 Days
Percentage of patients making at least 1 critical error with Genuair® (Pressair™) and Breezhaler® (Neohaler™) at Visit 2
The correct use of each device will be assessed measuring the errors made by patients when using each device after 2 weeks of daily practice Critical errors for each inhaler device are defined as those that compromise the potential benefit of the treatment such as impeding drug deposition in the lungs or the delivery of a sufficient dose
Time frame: 14 Days
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Almirall investigative site 5
Glasgow, United Kingdom
Almirall investigative site 6
Newcastle upon Tyne, United Kingdom