Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
To collect post-marketing safety and effectiveness information on the use of Tiotropium Inhalation Capsules (18 μg) in patients with chronic obstructive pulmonary disease in daily clinical settings
Interventions
DRUGSpiriva (tiotropium bromide) inhalation capsules
Survey of patients with COPD using Spiriva (tiotropium bromide) inhalation capsules
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
\- Patients with COPD
Exclusion criteria
-There is no exclusion criterion, because this post marketing study (PMS) is observational survey under condition of normal clinical practice
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with adverse events | Up to 4 weeks after start of treatment |
| Number of patients with adverse drug reactions | Up to 4 weeks after start of treatment |
| Number of patients with serious adverse events | Up to 4 weeks after start of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Physician's overall judgement by medical interview into four grades: 1. Improved 2. No Change 3. Aggravated 4.Unassessable | Up to 4 weeks after start of treatment |
Countries
Japan
Outcome results
None listed