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

Sponsors

Lead Sponsor: Almirall, S.A.

Collaborator: Forest Laboratories

Source Almirall, S.A.
Brief Summary

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

Overall Status Completed
Start Date July 2013
Completion Date October 2013
Primary Completion Date October 2013
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Percentage of patients who prefer Genuair® (Pressair™) versus Breezhaler® (Neohaler™) at Visit 2 14 Days
Secondary Outcome
Measure Time Frame
Mean for the overall satisfaction score with Genuair® (Pressair™) and Breezhaler® (Neohaler™) at Visit 2 14 Days
Percentage of patients making at least 1 critical error with Genuair® (Pressair™) and Breezhaler® (Neohaler™) at Visit 2 14 Days
Enrollment 128
Condition
Intervention

Intervention Type: Device

Intervention Name: Genuair®

Description: Inhaler with placebo only. Once daily, for 14 days.

Other Name: Pressair™

Intervention Type: Device

Intervention Name: Breezhaler®

Description: Inhaler with placebo only. Once daily, for 14 days.

Other Name: Neohaler®

Eligibility

Criteria:

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

Gender: All

Minimum Age: 40 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Jordi Estruch, MD Study Director Almirall, S.A.
Location
Facility:
Almirall investigative site 2 | Berlin, Germany
Almirall investigative site 1 | Munich, Germany
Almirall investigative site 3 | Barcelona, Spain
Almirall investigative site 4 | Palma de Mallorca, Spain
Almirall investigative site 5 | Glasgow, United Kingdom
Almirall investigative site 6 | Newcastle upon Tyne, United Kingdom
Location Countries

Germany

Spain

United Kingdom

Verification Date

May 2015

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Group A

Type: Experimental

Description: Genuair® (Pressair™) first; Breezhaler® (Neohaler™) second

Label: Group B

Type: Experimental

Description: Breezhaler® (Neohaler™) first; Genuair® (Pressair™) second

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Masking: None (Open Label)

Source: ClinicalTrials.gov