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

Study Evaluating Preference, Satisfaction and Ease of Use of Genuair® (Pressair™) and Breezhaler® (Neohaler™) Inhalers in Chronic Obstructive Pulmonary Disease (COPD) Diagnosed Patients

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

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Device: Genuair®; Device: Breezhaler®

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Genuair® (Pressair™) first; Breezhaler® (Neohaler™) second	Device: Genuair®; Inhaler with placebo only. Once daily, for 14 days.; Other Names: Pressair™; Device: Breezhaler®; Inhaler with placebo only. Once daily, for 14 days.; Other Names: Neohaler®
Experimental: Group B; Breezhaler® (Neohaler™) first; Genuair® (Pressair™) second	Device: Genuair®; Inhaler with placebo only. Once daily, for 14 days.; Other Names: Pressair™; Device: Breezhaler®; Inhaler with placebo only. Once daily, for 14 days.; Other Names: Neohaler®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	14 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	14 Days

Collaborators and Investigators

• Sponsor: Almirall, S.A.
• Collaborators: Forest Laboratories
• Investigators: Study Director: Jordi Estruch, MD, Almirall, S.A.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: August 1, 2013
• First Submitted That Met QC Criteria: August 1, 2013
• First Posted (Estimate): August 5, 2013

Study Record Updates

• Last Update Posted (Estimate): May 29, 2015
• Last Update Submitted That Met QC Criteria: May 28, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: M/34273/41