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

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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

NCT01915784
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

Trial design

128 participants in 2 patient groups

Group A
Experimental group
Description:
Genuair® (Pressair™) first; Breezhaler® (Neohaler™) second
Treatment:
Device: Breezhaler®
Device: Genuair®
Group B
Experimental group
Description:
Breezhaler® (Neohaler™) first; Genuair® (Pressair™) second
Treatment:
Device: Breezhaler®
Device: Genuair®

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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