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

Study Overview
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Brief Summary
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Preference study: Genuair vs HandiHaler inhalers in COPD patients.

Official Title
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Study Evaluating Preference, Satisfaction and Ease of Use of Inhalers in COPD Diagnosed Patients

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Device: Genuair® (Almirall S.A.)
* Device: HandiHaler® (Boehringer Ingelheim's)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group A<br>Genuair first, HandiHaler second | Device: Genuair® (Almirall S.A.)<br>* Inhaler with only placebo, once daily, 14 days<br>Device: HandiHaler® (Boehringer Ingelheim's)<br>* Inhaler with only placebo, once daily, 14 days<br>|
| Experimental: group B<br>HandiHaler first, Genuair second | Device: Genuair® (Almirall S.A.)<br>* Inhaler with only placebo, once daily, 14 days<br>Device: HandiHaler® (Boehringer Ingelheim's)<br>* Inhaler with only placebo, once daily, 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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. | 14 days |