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Open-label observational study: including COPD patients receiving treatment with Spiolto® Respimat® for approximately 6 weeks, which is the average time between two medical consultations
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COPD patients | Chronic obstructive pulmonary disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MaxSpiolto® Respimat® 160 Characters... | Drug | as per the approved SmPC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Achieving "Therapeutic Success" Defined as a ≥ 0.4 Point of Decrease in the Clinical COPD Questionnaire (CCQ) Score | Therapeutic success was defined as ≥0.4 point decrease in the Clinical COPD Questionnaire (CCQ) score between visit 1 (baseline visit at study start) and visit 2 (final visit at end of study, approximately 6 weeks after visit 1). The CCQ contained 10 questions about symptoms, functional status and mental status. Each of the 10 CCQ questions was scored by the patient on a 7-point scale (ranging between 0=asymptomatic/no-limitation, to 6=symptomatic/totally limited). The sum of the scores divided by 10 gives the CCQ score. A higher CCQ score is indicative of worse status. A decrease of 0.4 points is considered to be the minimal clinically important difference (MCID) for CCQ score. | Between visit 1 (baseline visit at study start) and visit 2 (final visit after end of study, approximately 6 weeks after visit 1). |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change in Clinical COPD Questionnaire (CCQ) Score Between Visit 1 and Visit 2 | Absolute change in Clinical COPD Questionaire (QQC) score between visit 1 (baseline visit at study start) and visit 2 (final visit at end of study, approximately 6 weeks after visit 1). The CCQ contained 10 questions about symptoms, functional status and mental status. Each of the 10 CCQ questions was scored by the patient on a 7-point scale between 0 and 6. The sum of the scores divided by 10 gives the CCQ score which measured the health and functional status. A higher CCQ score is indicative of worse status. |
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Inclusion Criteria:
Exclusion Criteria:
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1300 patients with chronic obstructive pulmonary disease (COPD) in whom combination treatment with long-acting bronchodilators is indicated in accordance with the guidelines are to be observed by approx. 100 pulmonologists in the setting of private practice. The NIS will take place in Greece and sites in urban as well as rural areas will be included. The nationwide distribution of the participating pulmonologists as well as the number of patients enrolled are intended to ensure that the data collected are representative.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Metropolitan | Aegina | 18547 | Greece | |||
| Metroplitan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33939158 | Derived | Kosmas E, Titopoulos I, Patentalakis G, Nikas N. An Observational Study Assessing Changes in Health and Functional Status in Patients with Chronic Obstructive Pulmonary Disease (COPD) During Therapy with Spiolto(R) Respimat(R) in Everyday Clinical Practice: The Greek ELLACTO Study. Pulm Ther. 2021 Dec;7(2):429-443. doi: 10.1007/s41030-021-00156-7. Epub 2021 May 3. |
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All participants were screened for eligibility to participate in the trial. Participants attended specialist sites which would then ensure that all participants met all inclusion and non of the exclusion criteria. 1 enrolled participant was excluded as he/she did not have at least one documented administration of Spiolto® Respimat®.
This was an open-label observational study to measure the effectiveness of 6 weeks treatment of Spiolto® Respimat® in Patients with Chronic Obstructive Pulmonary Disease (COPD). The Clinical COPD Questionnaire (CCQ)-score was used to evaluate changes in health and functional status.
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| ID | Title | Description |
|---|---|---|
| FG000 | Spiolto® Respimat® 2.5mg/2.5mg | 2.5microgram/2.5 microgram of Spiolto® Respimat® (tiotropium/olodaterol) was orally administered once daily via the Respimat inhaler over 6 weeks in patients with chronic obstructive pulmonary disease (COPD). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Treated Set (TS): Treated set included all screened patients with the informed consent, date of registration and at least one documented administration of Spiolto® Respimat®.
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| ID | Title | Description |
|---|---|---|
| BG000 | Spiolto® Respimat® 2.5mg/2.5mg | 2.5microgram/2.5 microgram of Spiolto® Respimat® (tiotropium/olodaterol) was orally administered once daily via the Respimat inhaler over 6 weeks in patients with chronic obstructive pulmonary disease (COPD). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Treated Set (TS): Treated Set included all screened patients with the informed consent, date of registration and at least one documented administration of Spiolto® Respimat®. |
| 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 Achieving "Therapeutic Success" Defined as a ≥ 0.4 Point of Decrease in the Clinical COPD Questionnaire (CCQ) Score | Therapeutic success was defined as ≥0.4 point decrease in the Clinical COPD Questionnaire (CCQ) score between visit 1 (baseline visit at study start) and visit 2 (final visit at end of study, approximately 6 weeks after visit 1). The CCQ contained 10 questions about symptoms, functional status and mental status. Each of the 10 CCQ questions was scored by the patient on a 7-point scale (ranging between 0=asymptomatic/no-limitation, to 6=symptomatic/totally limited). The sum of the scores divided by 10 gives the CCQ score. A higher CCQ score is indicative of worse status. A decrease of 0.4 points is considered to be the minimal clinically important difference (MCID) for CCQ score. | Full Analysis Set (FAS): The FAS comprised all patients of the Treated Set (TS) with a completed CCQ score at both visit 1 and visit 2. | Posted | Number | 95% Confidence Interval | Percentage of participants | Between visit 1 (baseline visit at study start) and visit 2 (final visit after end of study, approximately 6 weeks after visit 1). |
|
From study start until end of study, up to 6 weeks.
Adverse Events were reported for the Treated Set (TS). TS included all screened patients with the informed consent, date of registration and at least one documented administration of Spiolto® Respimat®.
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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 | Spiolto® Respimat® 2.5mg/2.5mg | 2.5microgram/2.5 microgram of Spiolto® Respimat® (tiotropium/olodaterol) was orally administered once daily via the Respimat inhaler over 6 weeks in patients with chronic obstructive pulmonary disease (COPD). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Centre | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 28, 2018 | Mar 30, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 26, 2019 | Mar 30, 2020 | SAP_001.pdf |
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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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| At visit 1 (baseline visit at study start) and at visit 2 (final visit at end of study, approximately 6 weeks after visit 1). |
| Absolute Change in the Functional Status Subdomain of Clinical COPD Questionnaire (CCQ-4) Score Between Visit 1 and Visit 2 | Absolute change in the functional status subdomain of Clinical COPD Questionnaire (CCQ-4) score between visit 1 (baseline visit at study start) and visit 2 (final visit at end of study, approximately 6 weeks after visit 1). The CCQ-4 score is a subdomain of the CCQ-score. It contains 4 questions about the functional status of patients. Each questions was scored by the patient on a 7-point scale, (ranging between 0=asymptomatic/no-limitation, to 6=symptomatic/totally limited). The QQC-4 score was calculated by the sum of 4 questions divided by 4. A higher CCQ-4 score was indicative of worse status. | At visit 1 (baseline visit at study start) and at visit 2 (final visit at the end of study, approximately 6 weeks after visit 1). |
| General Condition of Patient at Visit 1 and Visit 2 | General condition of the patient, evaluated by Physician´s Global Evaluation (PGE) score at visit 1 and visit 2. The PGE score uses a eight-point ordinal scale, ranging from poor (1,2) to excellent (7,8). | At visit 1 (baseline visit at study start) and at visit 2 (final visit at the end of study, approximately 6 weeks after visit 1). |
| Patients Satisfaction With Spiolto® Respimat® at Visit 2 | The patients satisfaction with Respimat was assessed at end of study (visit 2) by the Patient Satisfaction and Preference Questionnaire (PASAPQ) Part 1. PASAPQ Part 1 uses a 7-point ordinal scale, ranging from very dissatisfied to very satisfied, to rate the satisfaction with inhaler attributes. The patients were requested to describe their satisfaction level answering three questions. | At visit 2 (final visit, at the end of study, approximately 6 weeks after baseline visit). |
| Patients Preference for Spiolto® Respimat® at Visit 2 | Patients preference for Respimat® Inhaler vs. Spiriva HandiHaler (HH) was assessed using the abbreviated Patient Satisfaction and Preference Questionnaire (PASAPQ) Part 2 survey. Patients were requested to describe their preference for each inhaler device by answering 2 additional questions. | At visit 2 (final visit, at the end of study, approximately 6 weeks after baseline visit) |
| Patient's Willingness to Continue Treatment With Spiolto® Respimat® at Visit 2 | Patients' reported willingness to continue using either of the inhalers was measured with a scale score ranking from 0 to 100. 0 indicates not willing to continue using this inhaler and 100 indicates definitely willing to continue using it. | At visit 2 (final visit, at the end of study, approximately 6 weeks after baseline visit). |
| Athens |
| 18547 |
| Greece |
| Metropolitan | Athens | 18547 | Greece |
| Metropolitan | Chania | 18547 | Greece |
| Metropolitan | Heraklio | 18547 | Greece |
| Metropolitan | Hrakleio | 18547 | Greece |
| Metropolitan | Hraklio | 18547 | Greece |
| Diavalkaniko | Ioannina | 55535 | Greece |
| Diavalkaniko | Kavala | 55535 | Greece |
| Diavalkaniko | Larissa | 55535 | Greece |
| Metropolitan | Pátrai | 18547 | Greece |
| Diavalkaniko | Serres | 55535 | Greece |
| Merkouropoulos Markos | Thessaloniki | 54629 | Greece |
| Diavalkaniko | Thessaloniki | 55535 | Greece |
| Diavalkaniko | Volos | 55535 | Greece |
| Difficulty in inhaling the doses |
|
| Missing completion data |
|
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Treated Set: Treated Set included all screened patients with the informed consent, date of registration and at least one documented administration of Spiolto® Respimat®. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Title |
|---|
| Description |
|---|
| OG000 | Spiolto® Respimat® 2.5mg/2.5mg | 2.5microgram/2.5 microgram of Spiolto® Respimat® (tiotropium/olodaterol) was orally administered once daily via the Respimat inhaler over 6 weeks in patients with chronic obstructive pulmonary disease (COPD). |
|
|
| Secondary | Absolute Change in Clinical COPD Questionnaire (CCQ) Score Between Visit 1 and Visit 2 | Absolute change in Clinical COPD Questionaire (QQC) score between visit 1 (baseline visit at study start) and visit 2 (final visit at end of study, approximately 6 weeks after visit 1). The CCQ contained 10 questions about symptoms, functional status and mental status. Each of the 10 CCQ questions was scored by the patient on a 7-point scale between 0 and 6. The sum of the scores divided by 10 gives the CCQ score which measured the health and functional status. A higher CCQ score is indicative of worse status. | Full Analysis Set (FAS): The FAS comprised all patients of the Treated Set (TS) with a completed CCQ score at both visit 1 and visit 2. | Posted | Mean | Standard Deviation | CCQ-score | At visit 1 (baseline visit at study start) and at visit 2 (final visit at end of study, approximately 6 weeks after visit 1). |
|
|
|
| Secondary | Absolute Change in the Functional Status Subdomain of Clinical COPD Questionnaire (CCQ-4) Score Between Visit 1 and Visit 2 | Absolute change in the functional status subdomain of Clinical COPD Questionnaire (CCQ-4) score between visit 1 (baseline visit at study start) and visit 2 (final visit at end of study, approximately 6 weeks after visit 1). The CCQ-4 score is a subdomain of the CCQ-score. It contains 4 questions about the functional status of patients. Each questions was scored by the patient on a 7-point scale, (ranging between 0=asymptomatic/no-limitation, to 6=symptomatic/totally limited). The QQC-4 score was calculated by the sum of 4 questions divided by 4. A higher CCQ-4 score was indicative of worse status. | Full Analysis Set (FAS): The FAS comprised all patients of the Treated Set (TS) with a completed CCQ score at both visit 1 and visit 2. | Posted | Mean | Standard Deviation | CCQ-4 score | At visit 1 (baseline visit at study start) and at visit 2 (final visit at the end of study, approximately 6 weeks after visit 1). |
|
|
|
| Secondary | General Condition of Patient at Visit 1 and Visit 2 | General condition of the patient, evaluated by Physician´s Global Evaluation (PGE) score at visit 1 and visit 2. The PGE score uses a eight-point ordinal scale, ranging from poor (1,2) to excellent (7,8). | Full Analysis Set (FAS): The FAS comprised all patients of the Treated Set (TS) with a completed CCQ score at both visit 1 and visit 2. | Posted | Count of Participants | Participants | At visit 1 (baseline visit at study start) and at visit 2 (final visit at the end of study, approximately 6 weeks after visit 1). |
|
|
|
| Secondary | Patients Satisfaction With Spiolto® Respimat® at Visit 2 | The patients satisfaction with Respimat was assessed at end of study (visit 2) by the Patient Satisfaction and Preference Questionnaire (PASAPQ) Part 1. PASAPQ Part 1 uses a 7-point ordinal scale, ranging from very dissatisfied to very satisfied, to rate the satisfaction with inhaler attributes. The patients were requested to describe their satisfaction level answering three questions. | Full Analysis Set (FAS): The FAS comprised all patients of the Treated Set (TS) with a completed CCQ score at both visit 1 and visit 2. Only 1330 patients completed the PASAPQ Part1+Part2. | Posted | Count of Participants | Participants | At visit 2 (final visit, at the end of study, approximately 6 weeks after baseline visit). |
|
|
|
| Secondary | Patients Preference for Spiolto® Respimat® at Visit 2 | Patients preference for Respimat® Inhaler vs. Spiriva HandiHaler (HH) was assessed using the abbreviated Patient Satisfaction and Preference Questionnaire (PASAPQ) Part 2 survey. Patients were requested to describe their preference for each inhaler device by answering 2 additional questions. | Only patients from the Full Analysis Set (FAS), who have used Spiriva HandiHaler (HH) prior to the study. | Posted | Count of Participants | Participants | At visit 2 (final visit, at the end of study, approximately 6 weeks after baseline visit) |
|
|
|
| Secondary | Patient's Willingness to Continue Treatment With Spiolto® Respimat® at Visit 2 | Patients' reported willingness to continue using either of the inhalers was measured with a scale score ranking from 0 to 100. 0 indicates not willing to continue using this inhaler and 100 indicates definitely willing to continue using it. | Only patients from the Full Analysis Set (FAS), who have used Spiriva HandiHaler (HH) prior to the study. Only 253 patients were analyzed, as one patient did not answer the question. | Posted | Mean | Standard Deviation | Scores on scale | At visit 2 (final visit, at the end of study, approximately 6 weeks after baseline visit). |
|
|
|
| 0 |
| 1,359 |
| 1 |
| 1,359 |
| 0 |
| 1,359 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Excellent (7-8) |
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| Missing (Not Done) |
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| Visit 2 |
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| Neither satisfied nor dissatisfied |
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| Somewhat satisfied |
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| Satisfied |
|
| Very satisfied |
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| Missing |
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| Satisfaction with reliability of inhaler |
|
| Satisfaction with ease of inhaling |
|