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

Almirall

Status and phase

Completed

Phase 3

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Treatments

Device: Genuair®

Device: Breezhaler®

Study type

Interventional

Funder types

Industry

Identifiers

M/34273/41

Details and patient eligibility

About

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

Enrollment

128 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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