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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01915784
• Other study ID #: M/34273/41
• Status: Completed
• Phase: Phase 3
• First received: August 1, 2013
• Last updated: May 28, 2015
• Start date: July 2013
• Est. completion date: October 2013

Study information

• Verified date: May 2015
• Source: Almirall, S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyGermany: Federal Institute for Drugs and Medical DevicesSpain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Genuair®
Inhaler with placebo only. Once daily, for 14 days.
• Breezhaler®
Inhaler with placebo only. Once daily, for 14 days.

Locations

Country	Name	City	State
Germany	Almirall investigative site 2	Berlin
Germany	Almirall investigative site 1	Munich
Spain	Almirall investigative site 3	Barcelona
Spain	Almirall investigative site 4	Palma de Mallorca
United Kingdom	Almirall investigative site 5	Glasgow
United Kingdom	Almirall investigative site 6	Newcastle upon Tyne

Sponsors (2)

Lead Sponsor	Collaborator
Almirall, S.A.	Forest Laboratories

Countries where clinical trial is conducted

Germany,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No