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The objective of the present Post Marketing Surveillance Study (PMS) study is to evaluate safety and effectiveness of tiotropium bromide (Spiriva®) 18 µg once daily in 5,000 patients with COPD of varying severities over 8 weeks.
Study Design:
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| Measure | Description | Time Frame |
|---|---|---|
| Patient Global Assessment of Chronic Obstructive Pulmonary Disease (COPD) Symptom at Visit 1 and Visit 3 (Number of Patients Whose Assessment Were Excellent and Good) | The score is evaluated according to a 8-point scale(poor: 1-2, fair: 3-4, good: 5-6, excellent: 7-8; 1 point meaning most COPD-associated symptoms and signs and 8 point meaning least). Represents number of participants who score ""good"" and ""excellent"" at visit 1 (0 weeks) and visit 3 (8 weeks) | 0 weeks (Visit 1) and 8 weeks (Visit 3) |
| Patient Tolerability Assessment at Visit 3 | Patient tolerability assessment classified as "Unsatisfied", "Satisfied", "Good" and "Very Good" | 8 weeks (Visit 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Physician Global Assessment of Spiriva Effectiveness at Visit 2 and Visit 3 (Number of Patients Whose Assessment Were Excellent and Good) | The score is evaluated according to a 8-point scale(poor: 1-2, fair: 3-4, good: 5-6, excellent: 7-8; Represents number of participants who score ""good"" and ""excellent"" at visit 2 (2 weeks) and visit 3 (8 weeks) | 2 weeks (Visit 2 and 8 weeks (Visit 3) |
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Inclusion Criteria:
Incl. Criteria Patients with clinical diagnosis of stable Chronic Obstructive Pulmonary Disease (COPD) according to definition of China COPD guideline.
Patients over 40 years old
Exclusion Criteria:
Patient with history of hypersensitivity to tiotropium bromide, atropine and/or its derivant, i.e. ipratropium, or any component of Spiriva® Patient with known narrow-angle glaucoma
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primary care clinic
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
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There is a gap between the enrollment number (4922) and the started patients (treatment number, 4812), as some of the enrolled patients did not accept the treatment.
the number of started patients was 4918, among which 106 patients prematurely discontinued
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| ID | Title | Description |
|---|---|---|
| FG000 | Tiotropium Bromide |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tiotropium Bromide |
| 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 | Patient Global Assessment of Chronic Obstructive Pulmonary Disease (COPD) Symptom at Visit 1 and Visit 3 (Number of Patients Whose Assessment Were Excellent and Good) | The score is evaluated according to a 8-point scale(poor: 1-2, fair: 3-4, good: 5-6, excellent: 7-8; 1 point meaning most COPD-associated symptoms and signs and 8 point meaning least). Represents number of participants who score ""good"" and ""excellent"" at visit 1 (0 weeks) and visit 3 (8 weeks) | Sampling Method: Non-Probability Sample; conducted in primary care clinics. | Posted | Number | Participants | 0 weeks (Visit 1) and 8 weeks (Visit 3) |
|
|
8 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 | Tiotropium Bromide |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Exacerbation of chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (7.1) | 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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| Physician Tolerability Assessment at Visit 3 | The score is evaluated according to a 8-point scale(poor: 1-2, fair: 3-4, good: 5-6, excellent: 7-8) | 8 weeks (Visit 3) |
| issues not identified by investigators |
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| years |
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| Sex/Gender, Customized | Number | participants |
|
| Participants |
|
|
|
| Secondary | Physician Global Assessment of Spiriva Effectiveness at Visit 2 and Visit 3 (Number of Patients Whose Assessment Were Excellent and Good) | The score is evaluated according to a 8-point scale(poor: 1-2, fair: 3-4, good: 5-6, excellent: 7-8; Represents number of participants who score ""good"" and ""excellent"" at visit 2 (2 weeks) and visit 3 (8 weeks) | Posted | Number | Participants | 2 weeks (Visit 2 and 8 weeks (Visit 3) |
|
|
|
| Primary | Patient Tolerability Assessment at Visit 3 | Patient tolerability assessment classified as "Unsatisfied", "Satisfied", "Good" and "Very Good" | Full Analysis Set (FAS) | Posted | Number | Participants | 8 weeks (Visit 3) |
|
|
|
| Secondary | Physician Tolerability Assessment at Visit 3 | The score is evaluated according to a 8-point scale(poor: 1-2, fair: 3-4, good: 5-6, excellent: 7-8) | Full Analysis Set (FAS) | Posted | Number | Participants | 8 weeks (Visit 3) |
|
|
|
| 4 |
| 4,918 |
| 0 |
| 4,918 |
| Acute pancreatitis | Gastrointestinal disorders | MedDRA (7.1) | Systematic Assessment |
|
| Acute heart failure | Cardiac disorders | MedDRA (7.1) | Systematic Assessment |
|
| Chronic gastrointestinal bleeding | Gastrointestinal disorders | MedDRA (7.1) | Systematic Assessment |
|
| Multi-organ failure | General disorders | MedDRA (7.1) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (7.1) | Systematic Assessment |
|
| Shock | Vascular disorders | MedDRA (7.1) | Systematic Assessment |
|
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |