Special Survey Long-term Treatment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 385
- Locations
- 1
- Primary Endpoint
- Number of Patients With Adverse Events (AEs)
Study Overview
Brief Summary
Since Spiriva Inhalation Capsules 18mcg (hereinafter this product) are indicated for treatment of patients with chronic obstructive pulmonary disease (i.e. patients with chronic bronchitis or pulmonary emphysema) and usually intended for long-term use, the present survey is conducted to collect safety and effectiveness information on the use of this product for long period of time in daily clinical settings, and to obtain proper drug use information.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients of Chronic Obstructive Pulmonary Disease
- •Patients were expected to use the product for long period of time
Exclusion Criteria
- •Patients with glaucoma
- •Patients with micturition disorder due to prostatic hyperplasia etc.
- •Patients with a history of hypersensitivity to atropine or its derivatives or to any component of this product
Outcomes
Primary Outcomes
Number of Patients With Adverse Events (AEs)
Time Frame: Pre treatment and 52 weeks after the treatment
Number of patients with AEs
Number of Patients With Adverse Drug Reactions (ADRs)
Time Frame: Pre treatment and 52 weeks after the treatment
Number of Patients with ADRs. An adverse drug reaction was defined as an adverse event with a relationship to Tiotropium inhalation.
Secondary Outcomes
- Effective Rate of Comprehensive Evaluation(52 weeks)
- Change in Forced Expiratory Volume (L) in 1 Second at 52 Weeks(Pre treatment and 52 weeks after the treatment)