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| Name | Class |
|---|---|
| Forest Laboratories | INDUSTRY |
Preference study: Genuair® (Pressair™) vs Breezhaler® (Neohaler™) inhalers in patients with COPD
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Genuair® (Pressair™) first; Breezhaler® (Neohaler™) second |
|
| Group B | Experimental | Breezhaler® (Neohaler™) first; Genuair® (Pressair™) second |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genuair® | Device | Inhaler with placebo only. Once daily, for 14 days. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jordi Estruch, MD | Almirall, S.A. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Almirall investigative site 2 | Berlin | Germany | ||||
| Almirall investigative site 1 |
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| Breezhaler® | Device | Inhaler with placebo only. Once daily, for 14 days. |
|
|
| 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 |
| 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 |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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