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In COPD the patient's ability to use inhalers correctly and their preference for the inhaler are both important factors in selecting an appropriate treatment for COPD. This is a cross-sectional study where satisfaction, preference and handling of two different devices such as Respimat and Breezhaler will be evaluated by using the validated PASAPQ in COPD patients
Purpose:
Study Design:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 |
| ||
| Group 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group1:Spiriva® Respimat® | Device | COPD patients using Respimat® |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Total Mean Score of the Validated Patient Satisfaction and Preference Questionnaire (PASAPQ) | Patient satisfaction with regard to the total score of the handling of the inhaled devices performed by means of a PASAPQ. All questions were answered on a 7-point scale ranging from 1= very dissatisfied to 7 = very satisfied).To calculate the total score, the sum of the 13 items of the two domains (performance and convenience) was transformed to a 0- (least) to 100- (most) point scale which is scaled positively:higher scores represent higher levels of satisfaction. | day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Total Performance PASAPQ Score. | All questions were answered on a 7-point scale ranging from 1= very dissatisfied to 7 = very satisfied).To calculate the domain scores, the sum of the items of the performance domain was transformed to a 0- (least) to 100- (most) point scale which is scaled positively:higher scores represent higher levels of satisfaction. | day 1 |
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Inclusion criteria:
Exclusion criteria:
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COPD
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim Investigational Site 13 | A Coruña | Spain | ||||
| Boehringer Ingelheim Investigational Site 5 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Spiriva Respimat | Patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation. |
| FG001 | Hirobriz/Onbrez/Oslif Breezhaler | Patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients from the Treated Set (TS) who reported information about the last prescription of inhalation devices before the start of the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Spiriva Respimat | Chronic Obstructive Pulmonary Disease (COPD) patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation. |
| BG001 | Hirobriz/Onbrez/Oslif Breezhaler |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Total Mean Score of the Validated Patient Satisfaction and Preference Questionnaire (PASAPQ) | Patient satisfaction with regard to the total score of the handling of the inhaled devices performed by means of a PASAPQ. All questions were answered on a 7-point scale ranging from 1= very dissatisfied to 7 = very satisfied).To calculate the total score, the sum of the 13 items of the two domains (performance and convenience) was transformed to a 0- (least) to 100- (most) point scale which is scaled positively:higher scores represent higher levels of satisfaction. | Patients from the Full Analysis Set (FAS) which includes all patients from TS who provide evaluable data for the total score of the PASAPQ. | Posted | Mean | Standard Deviation | units on a scale | day 1 |
|
1 day
The occurrence of adverse events was assessed from signed informed consent to the completion of the questionnaire.
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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 | Spiriva Respimat | Chronic Obstructive Pulmonary Disease (COPD) patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| Group2:Hirobriz®/Oslif®/Onbrez® Breezhaler® |
| Device |
COPD patients using Breezhaler®® |
|
| Total Convenience PASAPQ Score | All questions were answered on a 7-point scale ranging from 1= very dissatisfied to 7 = very satisfied).To calculate the domain scores, the sum of the items of the convenience domain was transformed to a 0- (least) to 100- (most) point scale which is scaled positively:higher scores represent higher levels of satisfaction. | day 1 |
| Overall Satisfaction Question | The overall satisfaction ranges from 1=very dissatisfied to 7=very satisfied. | day 1 |
| Barcelona |
| Spain |
| Boehringer Ingelheim Investigational Site 6 | Barcelona | Spain |
| Boehringer Ingelheim Investigational Site 8 | Barcelona | Spain |
| Boehringer Ingelheim Investigational Site 12 | Burgos | Spain |
| Boehringer Ingelheim Investigational Site 14 | Galdako. | Spain |
| Boehringer Ingelheim Investigational Site 11 | Laredo | Spain |
| Boehringer Ingelheim Investigational Site 1 | Málaga | Spain |
| Boehringer Ingelheim Investigational Site 3 | Mérida | Spain |
| Boehringer Ingelheim Investigational Site 15 | Palma de Mallorca | Spain |
| Boehringer Ingelheim Investigational Site 9 | Pozuelo de Alarcón | Spain |
| Boehringer Ingelheim Investigational Site 7 | Sabadell | Spain |
| Boehringer Ingelheim Investigational Site 2 | Seville | Spain |
| Boehringer Ingelheim Investigational Site 10 | Torrelodones | Spain |
| Boehringer Ingelheim Investigational Site 4 | Villanueva de la Serena | Spain |
Chronic Obstructive Pulmonary Disease (COPD) patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Time since diagnosis of COPD | Mean | Standard Deviation | years |
|
| OG001 | Hirobriz/Onbrez/Oslif Breezhaler | Chronic Obstructive Pulmonary Disease (COPD) patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation. |
|
|
| Secondary | Total Performance PASAPQ Score. | All questions were answered on a 7-point scale ranging from 1= very dissatisfied to 7 = very satisfied).To calculate the domain scores, the sum of the items of the performance domain was transformed to a 0- (least) to 100- (most) point scale which is scaled positively:higher scores represent higher levels of satisfaction. | Patients from FAS. | Posted | Mean | Standard Deviation | units on a scale | day 1 |
|
|
|
| Secondary | Total Convenience PASAPQ Score | All questions were answered on a 7-point scale ranging from 1= very dissatisfied to 7 = very satisfied).To calculate the domain scores, the sum of the items of the convenience domain was transformed to a 0- (least) to 100- (most) point scale which is scaled positively:higher scores represent higher levels of satisfaction. | Patients from FAS. | Posted | Mean | Standard Deviation | units on a scale | day 1 |
|
|
|
| Secondary | Overall Satisfaction Question | The overall satisfaction ranges from 1=very dissatisfied to 7=very satisfied. | Patients from FAS | Posted | Mean | Standard Deviation | units on a scale | day 1 |
|
|
|
| 0 |
| 77 |
| 0 |
| 77 |
| EG001 | Hirobriz/Onbrez/Oslif Breezhaler | Chronic Obstructive Pulmonary Disease (COPD) patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation. | 0 | 77 | 0 | 77 |
Other - Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |