NCT01145053CompletedNot Applicable
Long Time Survey of RESPIMAT in Daily Clinical Use
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 361
- Primary Endpoint
- Incidence of Adverse Events (AEs)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 15 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Incidence of Adverse Events (AEs)
Time Frame: Week 52
The number of patient with any AEs, patients with drug-related AEs
Secondary Outcomes
- Amount of Sputum(Week 0 and Week 52)
- Nocturnal Sleep(Week 0 and Week 52)
- Effectiveness(Week 52)
- Forced Expiratory Volume in One Second (FEV1)(Week 0 and Week 52)
- Cough Frequency(Week 0 and Week 52)
- Shortness of Breath(Week 0 and Week 52)
Investigators
Similar Trials
Completed
Phase 3
Tiotropium / Respimat One-Year StudyPulmonary Disease, Chronic ObstructiveNCT00168831Boehringer Ingelheim1,007
Completed
Phase 3
Tiotropium / Respimat One-Year StudyPulmonary Disease, Chronic ObstructiveNCT00168844Boehringer Ingelheim983
Completed
Phase 3
Open-label Extension Study of the Phase 3 VRX-RET-E22-301 Double-Blind TrialEpilepsyNCT00310375GlaxoSmithKline181
Completed
Not Applicable
Impact of Tiotropium Add-on Therapy in Patients With AsthmaAsthmaNCT03964220Boehringer Ingelheim7,857
Completed
Phase 3
Tiotropium / Respimat One Year Study in COPD.Pulmonary Disease, Chronic ObstructiveNCT00387088Boehringer Ingelheim3,991