Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Brief summary
Preference study: Genuair® (Pressair™) vs Breezhaler® (Neohaler™) inhalers in patients with COPD
Interventions
DEVICEGenuair®
Inhaler with placebo only. Once daily, for 14 days.
DEVICEBreezhaler®
Inhaler with placebo only. Once daily, for 14 days.
Sponsors
Forest Laboratories
Almirall, S.A.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult male or female patients aged ≥40 years with stable moderate-to-severe COPD according to the GOLD Guidelines classification (grades II and III): forced expiratory volume in 1 second (measured between 10 to 15 minutes post-inhalation of 400 μg of salbutamol) is 30%≤FEV1\<80% of the predicted normal value * Patients naïve to both study inhaler devices, Genuair® and Breezhaler®, for at least 2 years * Agreement to participate and voluntarily sign the informed consent form
Exclusion criteria
* Patients with other clinically significant uncontrolled chronic diseases, particularly body malformations or diseases affecting coordination and/or motor system * Patients unable to read product package instructions and answer patient reported questionnaires (PASAPQ) * Patients with any other serious or uncontrolled mental health problems * Patients currently participating in other randomised clinical studies * Patients with COPD exacerbation within 6 weeks before Visit 1 and patient hospitalised for COPD exacerbation within 3 months prior to Visit 1 * Patients with any other conditions that, in the investigator's opinion, might indicate the patient to be inappropriate for the study * Patient likely to be uncooperative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients who prefer Genuair® (Pressair™) versus Breezhaler® (Neohaler™) at Visit 2 | 14 Days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean for the overall satisfaction score with Genuair® (Pressair™) and Breezhaler® (Neohaler™) at Visit 2 | 14 Days | 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. |
| Percentage of patients making at least 1 critical error with Genuair® (Pressair™) and Breezhaler® (Neohaler™) at Visit 2 | 14 Days | 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 |
Countries
Germany, Spain, United Kingdom
Outcome results
None listed