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The objective of this NIS is to measure changes in health status including functional status using CCQ scores in COPD patients receiving treatment with Spiolto® Respimat® according to label after approximately 6 weeks in routine clinical practice.
The objective of this NIS is to measure changes in health status including functional status using CCQ scores in COPD patients receiving treatment with Spiolto® Respimat® according to label after approximately 6 weeks in routine clinical practice.
In visit 1, patient data on demographics, smoking status, medical history, breathlessness, general condition, health and functional status and adverse drug reactions will be collected. In visit 2, after approximately 6 weeks, data on smoking status, concomitant diseases and medication, general condition, health and functional status and adverse drug reactions will be collected; additionally data on patient satisfaction, continuation or discontinuation of treatment and the reason in case of discontinuation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients treated with Spiolto® Respimat® | Patients with COPD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spiolto® Respimat® | Drug | 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Therapeutic Success | The primary endpoint of the study was "therapeutic success" at visit 2. The CCQ questionnaire 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 at baseline and at the end of observation after approximately 6 weeks. The sum of the scores divided by 10 gives the CCQ score which measures the health and functional status. 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 both CCQ score and CCQ-4. | Final visit at the end of the study, approximately 6 weeks after start of study |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Changes in CCQ and CCQ-4 From Visit 1 to Visit 2 | Absolute changes in total CCQ score and CCQ-4 score from baseline visit at the start of the study to final visit at the end of study. The CCQ questionnaire contained 10 questions about symptoms, functional status and mental status. The sum of the scores divided by 10 gives the CCQ score which measures the health and functional status. A higher CCQ score is indicative of worse status. A change of 0.4 points is was considered to be the minimal clinically important difference (MCID) for both CCQ score and CCQ-4. |
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Inclusion Criteria:
Patients can be included if all of the following criteria are met:
Exclusion Criteria:
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approximately 1300 patients from approximately 400 sites in Germany will be collected. Site selection will be performed to reflect routine COPD care in Germany in order to secure representativeness of the COPD population.
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Marseille, 49613277141881 | andrea.marseille@boehringer-ingelheim.com | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Weghmann | Aachen | 52066 | Germany | |||
| Praxis Edgar Schaubert |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34513983 | Derived | Gillissen A, Marseille A, Skowasch D, Ritz J, Mattiucci-Guehlke M, Pabst S, Greulich T, Koczulla R. Health and functional status of tiotropium/olodaterol-treated patients with COPD: results from the AERIAL(R) non-interventional study. ERJ Open Res. 2021 Sep 6;7(3):00004-2021. doi: 10.1183/23120541.00004-2021. eCollection 2021 Jul. |
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All subjects were screened for eligibility to participate in trial. Subjects attended specialist site to ensure that they (the subjects) met all implemented inclusion/exclusion criteria.
Chronic obstructive pulmonary disease patients receiving treatment with Spiolto® Respimat® for approximately 6 weeks in routine clinical practice
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| ID | Title | Description |
|---|---|---|
| FG000 | Spiolto® Respimat® | Spiolto® Respimat® 2.5 microgram/2.5 microgram per puff inhalation solution Baseline visit at the start of the study |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Visit 1 |
|
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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 | Apr 24, 2017 | Mar 16, 2020 |
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| Final visit at the end of the study, approximately 6 weeks after start of study |
| General Condition of the Patient | General condition of the patient, evaluated by the physician (Physician's global Evaluation score) at visit 1 and visit 2. The treating physician used the Physician's Global Evaluation (PGE) to evaluate the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8 (excellent). The modified Medical Research Council (mMRC) scale was used to assess the breathlessness state of the patient before the treatment. | Baseline visit (Visit 1) at the start of the study and final visit at the end of the study (visit 2), approximately 6 weeks after visit 1 |
| Patient Satisfaction With Spiolto® Respimat® at Visit 2 | A patient satisfaction survey was performed at visit 2, using a 7-point ordinal scale with divisions from very dissatisfied to very satisfied. The 7-item satisfaction scale is a self-designed Boehringer-Ingelheim scale, without a public source or validation status. | 6 weeks |
| Number of Participants Willing to Continue Treatment With Spiolto® Respimat® at Visit 2 | To assess the willingness to continue treatment with Spiolto® Respimat® at visit 2 patients were asked a yes/no question if they would continue the treatment. | 6 weeks |
| Aldenhoven |
| 52457 |
| Germany |
| MZM Medizin Zentr. Marienstrasse | Aldenhoven B Jülich | 52457 | Germany |
| Praxis Dr. Selbig | Ansbach | 91522 | Germany |
| Dr. Ludwig | Bad Bentheim | 48455 | Germany |
| Dr. Jung | Bad Ditzenbach | 73342 | Germany |
| Praxis Dr. med. Graubner | Bad Sachsa | 37441 | Germany |
| Dr. Callitsis | Bad Vilbel | 61118 | Germany |
| Dr. Junggeburth | Bad Wörishofen | 86825 | Germany |
| Praxis Edgar Hossbach | Berkatal-Frankershausen | 37297 | Germany |
| Dr. Urban | Berlin | 10711 | Germany |
| Praxis Abdullah Sahan | Berlin | 12049 | Germany |
| Dr. Kopf | Berlin | 12459 | Germany |
| Dr. Thalhofer | Berlin | 14163 | Germany |
| Gemeinschaftspraxis Dres. Wetterau/Dimar | Biberach | 88400 | Germany |
| Dr. Kassik | Bitterfeld-Wolfen | 06749 | Germany |
| Dr. Biedermann | Blankenhain , Thür | 99444 | Germany |
| Praxis Dr. Andreas Schwittay | Böhlen | 04564 | Germany |
| Gemeinschaftspraxis Dres. Bartels | Breuberg | 64747 | Germany |
| Dres. Ottlewski/Sutor | Burgwedel | 30938 | Germany |
| Praxis B. Metzlaff | Büchen | 21514 | Germany |
| Praxis A. Hermann/L. Hermann | Cloppenburg | 49661 | Germany |
| Praxis Dr. Käßner | Cottbus | 03050 | Germany |
| Dres. Forster/Kneser/Steinmetz | Darmstadt | 64283 | Germany |
| Dres. Jung/Jung | Deggingen | 73326 | Germany |
| Dr. Franz | Dietzenbach | 63128 | Germany |
| Dres. Tietjens/Tobias | Dortmund | 44135 | Germany |
| Dr. Schwiese | Duisburg | 47051 | Germany |
| Dr. Kontny | Duisburg | 47055 | Germany |
| Dres. Berger/Schäfer/Winkels | Düren | 52349 | Germany |
| Gemeinschaftspraxis Dres. Rommelmann/Lange/Geist/Neise | Düsseldorf | 40217 | Germany |
| Ges. f. Med. Fortbildung | Düsseldorf | 40547 | Germany |
| Praxis Dr. Andreas Kroll | Einbeck | 37574 | Germany |
| Dr. Schmidt | Erfurt | 99084 | Germany |
| Dres. Brüning/Schax | Essen | 45134 | Germany |
| Praxis Dr. Schmorell | Forchheim | 91301 | Germany |
| Dres. Engelhard/Wihl | Frankenberg | 35066 | Germany |
| Studienzentrum Dr. Klaus Keller | Frankfurt | 60389 | Germany |
| Dr. Morgner | Freiberg | 09599 | Germany |
| Allgemeinmedizinische Gemeinschaftspraxis Dres. Fischer/Fischer | Friedrichsthal | 66299 | Germany |
| Dr. Xanthopoulos | Fürstenwalde | 15517 | Germany |
| Praxis A. Heinze | Fürstenwalde | 15517 | Germany |
| Dr. Sommer | Garmisch-Partenkirchen | 82467 | Germany |
| Praxis C. Staack/Z. Zadrozny | Gelsenkirchen | 45891 | Germany |
| Praxis Dr. Körössy | Geretsried | 82538 | Germany |
| Das HausarztZentrum | Grafenrheinfeld | 97506 | Germany |
| Dres. Koenen & Partner | Grafenrheinfeld | 97506 | Germany |
| Praxis Dr. med. Werner Gams | Gütersloh | 33330 | Germany |
| Dr. Waida | Haan | 42781 | Germany |
| Pneumologicum Halle | Halle | 06108 | Germany |
| Praxis J. Lemke | Halle | 06110 | Germany |
| Dr. Polke | Hamburg | 20357 | Germany |
| Praxis Dr. Kaase | Hamburg | 22529 | Germany |
| Dr. Abenhardt | Heidelberg | 69115 | Germany |
| Praxis J. Hinrichs-Pavlik | Heidelberg , Neckar | 69115 | Germany |
| Praxis Dr. Constance Koch | Heilbad Heiligenstadt | 37308 | Germany |
| Praxis J. Korsakas | Heudeber | 38855 | Germany |
| Praxis Dres. Berg & Partner | Höchstadt an der Aisch | 91315 | Germany |
| Dr. Schulze | Jerichow | 39319 | Germany |
| Ambulantes Zentrum | Kalawa | 03205 | Germany |
| Dr. Schmitz | Kall | 53925 | Germany |
| Praxis Dr. Bernhard Beckmann | Kamen | 59174 | Germany |
| Praxis G. Mohanty | Kamp-Lintfort | 47475 | Germany |
| Praxis Dr. Dietrich Auge | Koblenz | 56068 | Germany |
| Dres. Lehmann/Schwerdtfeger | Köthen | 06366 | Germany |
| Praxis Dr. Astrid Pfitzer | Kronach | 96317 | Germany |
| KMG Klinikum Mitte GmbH | Kyritz , Prignitz | 16866 | Germany |
| Praxis Dr. Weberling | Lahnau | 35633 | Germany |
| POIS Leipzig GbR | Leipzig | 04357 | Germany |
| Dres. Bonitz/Hoheisel | Leipzig | 4275 | Germany |
| Dr. Seiz | Leonberg , Württ | 71229 | Germany |
| Praxis Dr. Hannelore Pitule | Ludwigshafen am Rhein | 67061 | Germany |
| Dres. Kock & Partner | Mainaschaff | 63814 | Germany |
| Dr. Saur | Mannheim | 68161 | Germany |
| Praxis Dr. Hermann A. Trauth | Marburg | 35037 | Germany |
| Gemeinschaftspraxis Dres. Jansen/Nolzen | Menden | 58706 | Germany |
| Dr. Bartsch | Moers | 47441 | Germany |
| Dr. Schipper | Monheim | 86653 | Germany |
| Praxis Hermann Ingerl | Mosbach | 74821 | Germany |
| Praxis Dr. Jan Feimer | München | 80539 | Germany |
| Thoraxzentrum Bez. Unterfranken | Münnerstadt | 97702 | Germany |
| Praxis Dipl. med Thomas Hagen | Neumarkt | 92318 | Germany |
| Praxis Wanda Wuttke | Nuremberg | 90478 | Germany |
| Praxis Dr. Volker E. Trapp | Nuremberg | 90489 | Germany |
| Praxis Dipl.-med. Anne-Kathrin Schmidt | Oschatz | 04758 | Germany |
| Dr. Bauer | Potsdam | 14480 | Germany |
| Praxis Dr. Rudolf Hennig | Radebeul | 01445 | Germany |
| Dr. Jasch-Hoppe | Rathenow | 14712 | Germany |
| Zentrum für Onkologie | Rostock | 18107 | Germany |
| Dres. Herold/Kaa | Roth , Mittelfr | 91154 | Germany |
| Lungenfachzentrum Rhein-Main | Rüsselsheim am Main | 65428 | Germany |
| MVZ für Atemwegserkrankungen | Schleswig | 24837 | Germany |
| Praxis S. Theuer | Seelow | 15306 | Germany |
| Dres. Knöbel/Olesch/Pelz-Knöbel | Straubing | 94315 | Germany |
| Dr. Eisenschmidt | Strausberg | 15344 | Germany |
| Dr. Schröter | Trier | 54290 | Germany |
| Dres. Barczok & Kollegen | Ulm, Donau | 89073 | Germany |
| Dres. Günther/Günther | Viernheim | 68519 | Germany |
| Überörtliche Gemeinschaftspraxis Dr. med. Albert Esselmann | Warendorf | 48231 | Germany |
| Dres. Herold/Kaa | Weißenburg I Bay | 91781 | Germany |
| Dres. Geissler/Geissler | Weißenfels, Saale | 06667 | Germany |
| Dres. Seidel/Röcher | Wiefelstede | 26215 | Germany |
| Dres. Fried/Thomas | Wiesbaden | 65183 | Germany |
| Praxis K.P. Schaps/H. Zimmeck | Wilhelmshaven | 26388 | Germany |
| Dr. Franz | Witten | 58452 | Germany |
| Dr. Weber | Witten | 58452 | Germany |
| Praxis D. Kubitscheck | Wittenberg | 06886 | Germany |
| Dr. Riegel | Wolfsburg | 38448 | Germany |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Visit 2 |
|
|
All patients who had given their written informed consent to study participation and at least one documented administration of Spiolto® Respimat® were included in the Treated Set (TS).
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| ID | Title | Description |
|---|---|---|
| BG000 | Spiolto® Respimat® at Study Start | Spiolto® Respimat® 2.5 microgram/2.5 microgram per puff inhalation solution Baseline visit at the start of the study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| CCQ Score | Each of the 10 Clinical chronic obstructive pulmonary disease questionaire (CCQ) questions is scored by the patient on a 7-point scale between 0 (Never/Not limited at all) and 6 (Almost all the time/Totally limited or unable to do). The (total) CCQ score measures the health and functional status. | CCQ at baseline is measured for patients with an observation of the score for visit 1 and visit 2. | Mean | Standard Deviation | Score |
|
| 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 | Therapeutic Success | The primary endpoint of the study was "therapeutic success" at visit 2. The CCQ questionnaire 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 at baseline and at the end of observation after approximately 6 weeks. The sum of the scores divided by 10 gives the CCQ score which measures the health and functional status. 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 both CCQ score and CCQ-4. | All screened patients with informed consent, at least one documented administration of Spiolto® Respimat® and available CCQ scores at visit 1 and visit 2, were defined as full analysis set (FAS). | Posted | Count of Participants | Participants | Final visit at the end of the study, approximately 6 weeks after start of study |
|
|
| ||||||||||||||||||||||||||
| Secondary | Assessment of Changes in CCQ and CCQ-4 From Visit 1 to Visit 2 | Absolute changes in total CCQ score and CCQ-4 score from baseline visit at the start of the study to final visit at the end of study. The CCQ questionnaire contained 10 questions about symptoms, functional status and mental status. The sum of the scores divided by 10 gives the CCQ score which measures the health and functional status. A higher CCQ score is indicative of worse status. A change of 0.4 points is was considered to be the minimal clinically important difference (MCID) for both CCQ score and CCQ-4. | All screened patients with informed consent, at least one documented administration of Spiolto® Respimat® and available CCQ scores at visit 1 and visit 2, were defined as full analysis set (FAS). | Posted | Mean | Standard Deviation | Percentage of patients (%) | Final visit at the end of the study, approximately 6 weeks after start of study |
|
| ||||||||||||||||||||||||||
| Secondary | General Condition of the Patient | General condition of the patient, evaluated by the physician (Physician's global Evaluation score) at visit 1 and visit 2. The treating physician used the Physician's Global Evaluation (PGE) to evaluate the general condition of the patient on an 8-point ordinal scale from 1 (very poor) to 8 (excellent). The modified Medical Research Council (mMRC) scale was used to assess the breathlessness state of the patient before the treatment. | All screened patients with informed consent, at least one documented administration of Spiolto® Respimat® and available CCQ scores at visit 1 and visit 2, were defined as full analysis set (FAS). | Posted | Count of Participants | Participants | Baseline visit (Visit 1) at the start of the study and final visit at the end of the study (visit 2), approximately 6 weeks after visit 1 |
|
| |||||||||||||||||||||||||||
| Secondary | Patient Satisfaction With Spiolto® Respimat® at Visit 2 | A patient satisfaction survey was performed at visit 2, using a 7-point ordinal scale with divisions from very dissatisfied to very satisfied. The 7-item satisfaction scale is a self-designed Boehringer-Ingelheim scale, without a public source or validation status. | All screened patients with informed consent, at least one documented administration of Spiolto® Respimat® and available CCQ scores at visit 1 and visit 2, were defined as full analysis set (FAS). | Posted | Count of Participants | Participants | 6 weeks |
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| |||||||||||||||||||||||||||
| Secondary | Number of Participants Willing to Continue Treatment With Spiolto® Respimat® at Visit 2 | To assess the willingness to continue treatment with Spiolto® Respimat® at visit 2 patients were asked a yes/no question if they would continue the treatment. | Patients with a performed visit 2 | Posted | Count of Participants | Participants | 6 weeks |
|
|
approximated up to 6 weeks after visit 1
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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 | Total | Spiolto® Respimat® 2.5 microgram/2.5 microgram per puff inhalation solution | 1 | 1,322 | 1 | 1,322 | 0 | 1,322 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 12, 2019 | Mar 16, 2020 | SAP_001.pdf |
| 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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| Functional state (CCQ-4) (Items: 7-10) |
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| Mental state (Items: 3; 4) |
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| Total CCQ score (All subscales) |
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| Participants |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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| Neither satisfied nor dissatisfied |
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| Rather dissatisfied |
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| Dissatisfied |
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| Very dissatisfied |
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| Neither satisfied nor dissatisfied |
|
| Rather dissatisfied |
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| Dissatisfied |
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| Very dissatisfied |
|