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Preference study: Genuair vs HandiHaler inhalers in COPD patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group A | Experimental | Genuair first, HandiHaler second |
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| group B | Experimental | HandiHaler first, Genuair second |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genuair® (Almirall S.A.) | Device | Inhaler with only placebo, once daily, 14 days |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jordi Estruch, Head of GMA | Almirall, S.A. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Almirall investigative site 3 | Bonn | 53119 | Germany | |||
| Almirall investigative site 5 |
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This study was conducted 4 centres, 2 in The Netherlands and 2 in Germany. The first patient was screened in June 2011 and the last patient visit was in January 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Genuair (Daily) Then Placebo HandiHaler (Daily) | Each morning, patients used the Genuair® (Almirall S.A.) inhaler containing placebo followed by the HandiHaler® (Boehringer Ingelheim) inhaler containing placebo. The study period consisted of 1 period of 14 days. |
| FG001 | Placebo HandiHaler (Daily) Then Placebo Genuair (Daily) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| HandiHaler® (Boehringer Ingelheim's) | Device | Inhaler with only placebo, once daily, 14 days |
|
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 |
| Koblenz |
| 56068 |
| Germany |
| Almirall investigative site 1 | Enschede | 7511 JX | Netherlands |
| Almirall investigative site 2 | Zutphen | 7207 AE | Netherlands |
Each morning, patients used the HandiHaler® (Boehringer Ingelheim) inhaler containing placebo followed by the Genuair® (Almirall S.A.) inhaler containing placebo. The study period consisted of 1 period of 14 days. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study Safety Population | All patients randomized into the study excluding 1 patient who used Handihaler® once only, Genuair® zero times, & was excluded from the safety population |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | ITT: all randomized patients who used both devices at least once and expressed a preference for either or neither inhaler. 24 patients (12 each arm) received the incorrect treatment allocation and were excluded from the ITT population. Missing data was handled via the observed cases approach. | Posted | Number | Percentage of Patients | 14 days |
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| Secondary | 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) | ITT: all randomized patients who used both devices at least once and expressed a preference for either or neither inhaler. 24 patients from the safety population (12 each arm) received the incorrect treatment allocation and were excluded from the ITT population. Missing data were handled via the observed cases approach. | Posted | Mean | 95% Confidence Interval | Units on a scale (1-5) | 14 days |
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| Secondary | 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. | ITT: all randomized patients who used both devices at least once and expressed a preference for either or neither inhaler. 24 patients from the safety population (12 each arm) received the incorrect treatment allocation and were excluded from the ITT population. Missing data were handled via the observed cases approach. | Posted | Number | Percentage of Patients | 14 days |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Genuair Then HandiHaler | The study period consisted of 1 period of 14 days. Every morning patients used the Genuair® (Almirall S.A.) inhaler containing placebo follow by the HandiHaler® (Boehringer Ingelheim) inhaler containing placebo. | 0 | 66 | 0 | 66 | ||
| EG001 | HandiHaler Then Genuair | The study period consisted of 1 period of 14 days. Every morning patients used the HandiHaler® (Boehringer Ingelheim)inhaler containing placebo follow by the Genuair® (Almirall S.A.) inhaler containing placebo. | 0 | 63 | 0 | 63 |
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All the information related to this clinical trial is considered strictly confidential and is the property of Almirall. This information will not be given to a third party without the written consent of Almirall. Publication and/or presentation, whether complete or partial, of any part of the data or results of this trial will be subject to revision and written agreement between the investigator and Almirall.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Leader and Trial Manager | Almirall S.A. | +34 93 291 3200 |
| 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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| Title | Measurements |
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