Study Evaluating Preference, Satisfaction and Ease of Use of Inhalers in Chronic Obstructive Pulmonary Disease (COPD) Diagnosed Patients

Phase 3CompletedNCT01385696

Almirall, S.A.130 enrolled

Overview

Preference study: Genuair vs HandiHaler inhalers in COPD patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

130

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Genuair® (Almirall S.A.)DEVICE

Inhaler with only placebo, once daily, 14 days

HandiHaler® (Boehringer Ingelheim's)DEVICE

Inhaler with only placebo, once daily, 14 days

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult male or female patients aged ≥ 40 with stable COPD * Naïve patients to the use of study inhalers * Patients agreeing on participating and signing the Informed Consent Form Exclusion Criteria: * Patients with other clinically significant disease, particularly body malformations or diseases affecting coordination and/or motor system * Patients unable to read product package instructions and answer patient reported questionnaires

Locations (4)

Almirall investigative site 3

Bonn, Germany

Almirall investigative site 5

Koblenz, Germany

Almirall investigative site 1

Enschede, Netherlands

Almirall investigative site 2

Zutphen, Netherlands

Outcomes

Primary Outcomes

Percentage of Patients Who Prefer Genuair Device Versus Handihaler Device at Visit 2

Patients will be asked to answer which device they prefer after 2 weeks of daily practice (visit 2)

Time frame: 14 days

Secondary Outcomes

Mean Overall Satisfaction With Genuair and Handihaler at Visit 2

The patient will be asked to rate the overall satisfaction with each device using a Likert-type scale (from 1 \[very dissatisfied\] to 5 \[very satisfied\]) after 2 weeks of daily practice (visit 2)

Time frame: 14 days

Percentage of Patients Making at Least 1 Critical Error Using the Genuair and Handihaler Devices at Visit 2

The correct use of devices will be assessed measuring the errors made by patients when using each device after 2 weeks of daily practice (visit 2). Critical error is defined as the one that compromise the potential benefit of the treatment such as those that impede drug deposition in the lungs or delivery of sufficient dose.

Time frame: 14 days

Data from ClinicalTrials.gov

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