Preference, Satisfaction and Ease of Use of Genuair® (Pressair™) and Breezhaler® (Neohaler™) Inhalers in Patients With COPD

Phase 3

Completed

Brief Summary: Preference study: Genuair® (Pressair™) vs Breezhaler® (Neohaler™) inhalers in patients with COPD

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Group B	Breezhaler®	Breezhaler® (Neohaler™) first; Genuair® (Pressair™) second
Group A	Breezhaler®	Genuair® (Pressair™) first; Breezhaler® (Neohaler™) second
Group B	Genuair®	Breezhaler® (Neohaler™) first; Genuair® (Pressair™) second
Group A	Genuair®	Genuair® (Pressair™) first; Breezhaler® (Neohaler™) second

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Locations (6): Almirall investigative site 5
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Glasgow, United Kingdom
Almirall investigative site 3
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Barcelona, Spain
Almirall investigative site 6
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Newcastle upon Tyne, United Kingdom
Almirall investigative site 4
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Palma de Mallorca, Spain
Almirall investigative site 2
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Berlin, Germany
Almirall investigative site 1
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Munich, Germany