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To investigate safety and effectiveness information on the use of Tiotropium Respimat for long time of period in daily practical clinical circumstances, and to obtain proper drug use information.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) | The number of patient with any AEs, patients with drug-related AEs | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness | Effectiveness should be comprehensively investigated based on the items of patients observation, test results of FEV1, clinical symptoms. The Effectiveness is classified into 3 category, 'Improved', 'No change' and 'Aggravated' by physician. | Week 52 |
| Forced Expiratory Volume in One Second (FEV1) |
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Inclusion criteria:
Patients with COPD who is expected to be treatable with long term. All patients must have a diagnosis of COPD and register after the start of treatment of Tiotropium Respimat.
Exclusion criteria:
There is no special restriction, because this PMS is an observational investigation under conditions of normal clinical practice. Spiriva Respimat is contraindicated in patients with hypersensitivity to Tiotropium bromide, atropine or its derivatives, e.g. ipratropium or oxitropium or to any of the excipients in Package labelling.
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300
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
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A total of 361 patients were enrolled. Of these patients, the CRF of 4 patients were uncollected by reason of institution, and the 16 patients who did not visit after enrollment. Then, total 341 patients were observed in the survey.
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| ID | Title | Description |
|---|---|---|
| FG000 | Spiriva Respimat | Spiriva 2.5 mcg Respimat 60 puffs |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Spiriva Respimat | Spiriva 2.5 mcg Respimat 60 puffs |
| 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 |
| 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 | Incidence of Adverse Events (AEs) | The number of patient with any AEs, patients with drug-related AEs | The all treated patients | Posted | Number | Patients | Week 52 |
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|
52 weeks
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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 | Spiriva 2.5 mcg Respimat 60 puffs |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
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| 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 |
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FEV1 is observed at Week 0 and Week 52. The change of FEV1 from Week 0 to Week 52 is calculated. |
| Week 0 and Week 52 |
| Cough Frequency | Cough frequency is rating 1 to 4 score based on patient's diary: 1=None; 2=A few times; 3=Frequently; 4=Very frequently. | Week 0 and Week 52 |
| Amount of Sputum | Amount of Sputum is rating 1 to 4 score based on patient's diary: 1= None; 2= Slight; 3=Slightly more; 4= Very much. | Week 0 and Week 52 |
| Shortness of Breath | Shortness of Breath is rating 1 to 6 score based on patient's diary: 1=No shortness of breath and no problem in activity in daily life (ADL); 2=Despite shortness of breath, can move about like other people of the same age and no problem in ADL; 3=Can walk fast for a short time but activities like other people of the same age are not possible; 4=Can walk normally, go up the stairs slowly but quick motion is difficult; 5=Can walk slowly in the neighborhood but shortness of breath occurs; 6= Due to severe shortness of breath, rested at home all day. | Week 0 and Week 52 |
| Nocturnal Sleep | Nocturnal Sleep is rating 1 to 5 score based on patient's diary: 1=Sputum and cough hardly made me awake; 2=Sputum and cough only one time made me awake; 3=Sputum and cough 2 or 3 times made me awake; 4=Sputum and cough 4 to 6 times made me awake; 5=Sputum and cough made me awake all night. | Week 0 and Week 52 |
| Other |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | Effectiveness | Effectiveness should be comprehensively investigated based on the items of patients observation, test results of FEV1, clinical symptoms. The Effectiveness is classified into 3 category, 'Improved', 'No change' and 'Aggravated' by physician. | The 25 patients which were non approved indication patients and no efficacy information, were excluding from safety set, 316 patients were included in efficacy set. | Posted | Number | Patients | Week 52 |
|
|
|
| Secondary | Forced Expiratory Volume in One Second (FEV1) | FEV1 is observed at Week 0 and Week 52. The change of FEV1 from Week 0 to Week 52 is calculated. | The 25 patients which were non approved indication patients and no efficacy information, were excluding from safety set, 316 patients were included in efficacy set. In the efficacy set, 105 patients measured FEV1 . | Posted | Mean | Standard Deviation | L | Week 0 and Week 52 |
|
|
|
| Secondary | Cough Frequency | Cough frequency is rating 1 to 4 score based on patient's diary: 1=None; 2=A few times; 3=Frequently; 4=Very frequently. | The 25 patients which were non approved indication patients and no efficacy information, were excluding from safety set, 316 patients were included in efficacy set. In the efficacy set, 309 patients recorded the Cough Frequency . | Posted | Mean | Standard Deviation | Units on a scale | Week 0 and Week 52 |
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|
|
| Secondary | Amount of Sputum | Amount of Sputum is rating 1 to 4 score based on patient's diary: 1= None; 2= Slight; 3=Slightly more; 4= Very much. | The 25 patients which were non approved indication patients and no efficacy information, were excluding from safety set, 316 patients were included in efficacy set. In the efficacy set, 309 patients recorded the Amount of Sputum. | Posted | Mean | Standard Deviation | Units on a scale | Week 0 and Week 52 |
|
|
|
| Secondary | Shortness of Breath | Shortness of Breath is rating 1 to 6 score based on patient's diary: 1=No shortness of breath and no problem in activity in daily life (ADL); 2=Despite shortness of breath, can move about like other people of the same age and no problem in ADL; 3=Can walk fast for a short time but activities like other people of the same age are not possible; 4=Can walk normally, go up the stairs slowly but quick motion is difficult; 5=Can walk slowly in the neighborhood but shortness of breath occurs; 6= Due to severe shortness of breath, rested at home all day. | The 25 patients which were non approved indication patients and no efficacy information, were excluding from safety set, 316 patients were included in efficacy set. In the efficacy set, 309 patients recorded the Shortness of Breath. | Posted | Mean | Standard Deviation | Units on a scale | Week 0 and Week 52 |
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|
|
| Secondary | Nocturnal Sleep | Nocturnal Sleep is rating 1 to 5 score based on patient's diary: 1=Sputum and cough hardly made me awake; 2=Sputum and cough only one time made me awake; 3=Sputum and cough 2 or 3 times made me awake; 4=Sputum and cough 4 to 6 times made me awake; 5=Sputum and cough made me awake all night. | The 25 patients which were non approved indication patients and no efficacy information, were excluding from safety set, 316 patients were included in efficacy set. In the efficacy set, 308 patients recorded the Nocturnal Sleep. | Posted | Mean | Standard Deviation | Units on a scale | Week 0 and Week 52 |
|
|
|
| 27 |
| 341 |
| 0 |
| 341 |
| Cor pulmonale | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
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| Cataract | Eye disorders | MedDRA 15.0 | Systematic Assessment |
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| Maculopathy | Eye disorders | MedDRA 15.0 | Systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Death | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Pneumonia bacterial | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Atypical mycobacterial infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
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| Small cell lung cancer stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
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| Metastases to chest wall | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
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| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
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| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
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| Loss of consciousness | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Chronic respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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