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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
The objective of this observational study is to collect and evaluate data on medication adherence of patients on maintenance COPD therapy with long-acting anticholinergic (e.g. Spiriva® delivered by HandiHaler® or Respimat®) using the MMAS-8 questionnaire.
Purpose:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with COPD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Education | Procedure | Education |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Educational Period After 6 Months From Baseline | The MMAS-8 scale is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation. It has been agreed that the score of 8 could be categorized as having high adherence, score between 6 and 7 as medium adherence and scores of 5 and less as low adherence. The change is presented as the score on visit 3 minus the score at baseline. Therefore, a positive change score reflects an improvement in the adherence. | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Observational Period After 12 Months From End of Educational Period After 6 Months. | The MMAS-8 scale is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation. It has been agreed that the score of 8 could be categorized as having high adherence, score between 6 and 7 as medium adherence and scores of 5 and less as low adherence. The change is presented as the score on visit 4 minus the score at visit 3. Therefore, a positive change score reflects an improvement in the adherence. |
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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 58 | Baja | Hungary | ||||
| Boehringer Ingelheim Investigational Site 85 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With COPD | Patients with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) being treated with the maintenance therapy with long-acting anticholinergic (Tiotropium) for at least 1 month and within product label. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| 6 months and 12 months |
| Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Observational Period After 12 Months From Baseline | The MMAS-8 scale is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation. It has been agreed that the score of 8 could be categorized as having high adherence, score between 6 and 7 as medium adherence and scores of 5 and less as low adherence. The change is presented as the score on visit 4 minus the score at visit 1 (baseline). Therefore, a positive change score reflects an improvement in the adherence. | 12 months and baseline |
| Békéscsaba |
| Hungary |
| Boehringer Ingelheim Investigational Site 61 | Budapest | Hungary |
| Boehringer Ingelheim Investigational Site 62 | Budapest | Hungary |
| Boehringer Ingelheim Investigational Site 63 | Budapest | Hungary |
| Boehringer Ingelheim Investigational Site 66 | Budapest | Hungary |
| Boehringer Ingelheim Investigational Site 67 | Budapest | Hungary |
| Boehringer Ingelheim Investigational Site 68 | Budapest | Hungary |
| Boehringer Ingelheim Investigational Site 89 | Budapest | Hungary |
| Boehringer Ingelheim Investigational Site 90 | Budapest | Hungary |
| Boehringer Ingelheim Investigational Site 55 | Cegléd | Hungary |
| Boehringer Ingelheim Investigational Site 51 | Debrecen | Hungary |
| Boehringer Ingelheim Investigational Site 64 | Dunakeszi | Hungary |
| Boehringer Ingelheim Investigational Site 77 | Dunaújváros | Hungary |
| Boehringer Ingelheim Investigational Site 56 | Edelény | Hungary |
| Boehringer Ingelheim Investigational Site 78 | Esztergom | Hungary |
| Boehringer Ingelheim Investigational Site 86 | Érd | Hungary |
| Boehringer Ingelheim Investigational Site 60 | Gyöngyös | Hungary |
| Boehringer Ingelheim Investigational Site 52 | Hajdúnánás | Hungary |
| Boehringer Ingelheim Investigational Site 81 | Kaposvár | Hungary |
| Boehringer Ingelheim Investigational Site 54 | Kecskemét | Hungary |
| Boehringer Ingelheim Investigational Site 59 | Kistokaj | Hungary |
| Boehringer Ingelheim Investigational Site 71 | Komárom | Hungary |
| Boehringer Ingelheim Investigational Site 74 | Komló | Hungary |
| Boehringer Ingelheim Investigational Site 65 | Mátraháza | Hungary |
| Boehringer Ingelheim Investigational Site 72 | Mosonmagyaróvár | Hungary |
| Boehringer Ingelheim Investigational Site 83 | Nyírbátor | Hungary |
| Boehringer Ingelheim Investigational Site 53 | Nyíregyháza | Hungary |
| Boehringer Ingelheim Investigational Site 88 | Nyíregyháza | Hungary |
| Boehringer Ingelheim Investigational Site 73 | Pécs | Hungary |
| Boehringer Ingelheim Investigational Site 87 | Szeged | Hungary |
| Boehringer Ingelheim Investigational Site 84 | Szentes | Hungary |
| Boehringer Ingelheim Investigational Site 69 | Szigetszentmiklós | Hungary |
| Boehringer Ingelheim Investigational Site 82 | Szombathely | Hungary |
| Boehringer Ingelheim Investigational Site 76 | Tapolca | Hungary |
| Boehringer Ingelheim Investigational Site 79 | Tatabánya | Hungary |
| Boehringer Ingelheim Investigational Site 57 | Tiszaújváros | Hungary |
| Boehringer Ingelheim Investigational Site 70 | Törökszentmiklós | Hungary |
| Boehringer Ingelheim Investigational Site 75 | Várpalota | Hungary |
| Boehringer Ingelheim Investigational Site 80 | Zalaegerszeg | Hungary |
| Boehringer Ingelheim Investigational Site 29 | Banská Bystrica | Slovakia |
| Boehringer Ingelheim Investigational Site 41 | Bardejov | Slovakia |
| Boehringer Ingelheim Investigational Site 42 | Bardejov | Slovakia |
| Boehringer Ingelheim Investigational Site 32 | Bojnice | Slovakia |
| Boehringer Ingelheim Investigational Site 1 | Bratislava | Slovakia |
| Boehringer Ingelheim Investigational Site 9 | Bratislava | Slovakia |
| Boehringer Ingelheim Investigational Site 45 | Čadca | Slovakia |
| Boehringer Ingelheim Investigational Site 28 | Galanta | Slovakia |
| Boehringer Ingelheim Investigational Site 17 | Gelnica | Slovakia |
| Boehringer Ingelheim Investigational Site 26 | Hurbanovo | Slovakia |
| Boehringer Ingelheim Investigational Site 12 | Košice | Slovakia |
| Boehringer Ingelheim Investigational Site 13 | Košice | Slovakia |
| Boehringer Ingelheim Investigational Site 14 | Košice | Slovakia |
| Boehringer Ingelheim Investigational Site 15 | Košice | Slovakia |
| Boehringer Ingelheim Investigational Site 16 | Košice | Slovakia |
| Boehringer Ingelheim Investigational Site 25 | Levice | Slovakia |
| Boehringer Ingelheim Investigational Site 33 | Lučenec | Slovakia |
| Boehringer Ingelheim Investigational Site 35 | Lučenec | Slovakia |
| Boehringer Ingelheim Investigational Site 36 | Lučenec | Slovakia |
| Boehringer Ingelheim Investigational Site 44 | Martin | Slovakia |
| Boehringer Ingelheim Investigational Site 38 | Michalovce | Slovakia |
| Boehringer Ingelheim Investigational Site 4 | Myjava | Slovakia |
| Boehringer Ingelheim Investigational Site 22 | Nitra | Slovakia |
| Boehringer Ingelheim Investigational Site 23 | Nitra | Slovakia |
| Boehringer Ingelheim Investigational Site 24 | Nitra | Slovakia |
| Boehringer Ingelheim Investigational Site 30 | Nová Bana | Slovakia |
| Boehringer Ingelheim Investigational Site 48 | Nové Mesto N. Váhom | Slovakia |
| Boehringer Ingelheim Investigational Site 19 | Nové Zámky | Slovakia |
| Boehringer Ingelheim Investigational Site 20 | Nové Zámky | Slovakia |
| Boehringer Ingelheim Investigational Site 21 | Nové Zámky | Slovakia |
| Boehringer Ingelheim Investigational Site 5 | Piešťany | Slovakia |
| Boehringer Ingelheim Investigational Site 47 | Povazská Bystrica | Slovakia |
| Boehringer Ingelheim Investigational Site 39 | Prešov | Slovakia |
| Boehringer Ingelheim Investigational Site 40 | Prešov | Slovakia |
| Boehringer Ingelheim Investigational Site 31 | Prievidza | Slovakia |
| Boehringer Ingelheim Investigational Site 11 | Rimavská Sobota | Slovakia |
| Boehringer Ingelheim Investigational Site 34 | Rimavská Sobota | Slovakia |
| Boehringer Ingelheim Investigational Site 10 | Rožňava | Slovakia |
| Boehringer Ingelheim Investigational Site 2 | Senec | Slovakia |
| Boehringer Ingelheim Investigational Site 3 | Senica | Slovakia |
| Boehringer Ingelheim Investigational Site 18 | Spisská Nová Ves | Slovakia |
| Boehringer Ingelheim Investigational Site 37 | Stropkov | Slovakia |
| Boehringer Ingelheim Investigational Site 27 | Topoľčany | Slovakia |
| Boehringer Ingelheim Investigational Site 6 | Trnava | Slovakia |
| Boehringer Ingelheim Investigational Site 7 | Trnava | Slovakia |
| Boehringer Ingelheim Investigational Site 8 | Trnava | Slovakia |
| Boehringer Ingelheim Investigational Site 46 | Trstená | Slovakia |
| Boehringer Ingelheim Investigational Site 43 | Žilina | Slovakia |
| Boehringer Ingelheim Investigational Site 49 | Golnik | Slovenia |
| Boehringer Ingelheim Investigational Site 50 | Maribor-Pohorje | Slovenia |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Patients from the Treated Set: This patient set includes all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment. As it was an inclusion criterion that all patients were treated with Spiriva within the last month, TS consists of all patients involved in the trial.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Patients With COPD | Patients with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) being treated with the maintenance therapy with long-acting anticholinergic (Tiotropium) for at least 1 month and within product label. |
| 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 |
|
| 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 | Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Educational Period After 6 Months From Baseline | The MMAS-8 scale is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation. It has been agreed that the score of 8 could be categorized as having high adherence, score between 6 and 7 as medium adherence and scores of 5 and less as low adherence. The change is presented as the score on visit 3 minus the score at baseline. Therefore, a positive change score reflects an improvement in the adherence. | This patient set includes all patients in the TS who have valid MMAS-8 questionnaire results both at baseline and after 6 months. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Observational Period After 12 Months From End of Educational Period After 6 Months. | The MMAS-8 scale is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation. It has been agreed that the score of 8 could be categorized as having high adherence, score between 6 and 7 as medium adherence and scores of 5 and less as low adherence. The change is presented as the score on visit 4 minus the score at visit 3. Therefore, a positive change score reflects an improvement in the adherence. | This patient set includes all patients in the TS who have valid MMAS-8 questionnaire results after 6 and 12 months. | Posted | Mean | Standard Deviation | units on a scale | 6 months and 12 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Observational Period After 12 Months From Baseline | The MMAS-8 scale is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation. It has been agreed that the score of 8 could be categorized as having high adherence, score between 6 and 7 as medium adherence and scores of 5 and less as low adherence. The change is presented as the score on visit 4 minus the score at visit 1 (baseline). Therefore, a positive change score reflects an improvement in the adherence. | This patient set includes all patients in the TS who have valid MMAS-8 questionnaire results both at baseline and after 6 months. | Posted | Mean | Standard Deviation | units on a scale | 12 months and baseline |
|
|
12 months
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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 | Patients With COPD | Patients with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) being treated with the maintenance therapy with long-acting anticholinergic (Tiotropium) at least 1 months and within product label. | 59 | 1,253 | 0 | 1,253 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Metastases to lymph nodes | Blood and lymphatic system disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Cor pulmonale | Cardiac disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Syncope | Cardiac disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Gastroenteritis | Gastrointestinal disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Varices oesophageal | Gastrointestinal disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Death | General disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Pain | General disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Metastases to liver | Hepatobiliary disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MEDDRA 17.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MEDDRA 17.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MEDDRA 17.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MEDDRA 17.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MEDDRA 17.0 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MEDDRA 17.0 | Systematic Assessment |
| |
| Metastases to bone | Musculoskeletal and connective tissue disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Adenoma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 17.0 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 17.0 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 17.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Vascular encephalopathy | Nervous system disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Amnesia | Psychiatric disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Panic disorder | Psychiatric disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Ovarian neoplasm | Reproductive system and breast disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Lung adenocarcinoma | Respiratory, thoracic and mediastinal disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Lung neoplasm | Respiratory, thoracic and mediastinal disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Metastases to lung | Respiratory, thoracic and mediastinal disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Non-small cell lung cancer | Respiratory, thoracic and mediastinal disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Respiratory, thoracic and mediastinal disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Coronary arterial stent insertion | Surgical and medical procedures | MEDDRA 17.0 | Systematic Assessment |
| |
| Lung lobectomy | Surgical and medical procedures | MEDDRA 17.0 | Systematic Assessment |
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| Haemoptysis | Vascular disorders | MEDDRA 17.0 | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MEDDRA 17.0 | Systematic Assessment |
|
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| 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 |
Not provided
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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