N/A
N=754
Effect of Spiriva on the Activities of Daily Living Score Recommended in Austrian COPD Guidelines
Pulmonary Disease, Chronic Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT00615992 ↗Enrolled (actual)
754
Serious AEs
0.0%
Results posted
Dec 2009
Primary outcome: Primary: Activities of Daily Living Score After 3 to 4 Weeks Treatment With Spiriva — 1.1 points on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Tiotropium (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Activities of Daily Living Score After 3 to 4 Weeks Treatment With Spiriva |
1.1 | — |
| SECONDARY Dyspnea Score After 3 to 4 Weeks Treatment With Spiriva |
1.1 | — |
| SECONDARY Global Assessment of Efficacy by Patient |
373; 217; 53; 3 | — |
| SECONDARY Global Assessment of Tolerability by Patient |
493; 142; 11; 1 | — |
| SECONDARY Global Assessment of Efficacy by Physician |
407; 205; 36; 0 | — |
| SECONDARY Global Assessment of Tolerability by Physician |
540; 102; 5; 0 | — |
Summary
The primary goal of this post marketing surveillance (PMS) study is to document the efficacy of Tiotropium (Spiriva) to improve physical activity measured by a score that is recommended in national chronic obstructive pulmonary disease (COPD) guidelines for monitoring the course of the disease.
Eligibility Criteria
Inclusion Criteria
- Patients with suspected chronic obstructive pulmonary disease (COPD)
- 3 or more positive answers in COPD questionnaire
- Age over 40 years
Exclusion Criteria
- Patients with any conditions listed in special precautions, drug interactions, and contraindication of Spiriva in the summary of product characteristics
- Patient treated with Spiriva in the past year
- 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 Patient with known symptomatic prostatic hyperplasia and/or bladder-neck obstruction Patient with known moderate to severe renal impairment (i.e.,creatinine clearance<=50ml/min) Pregnant or nursing women Patient with any significant disease other than COPD which would exclude him/her from participating in the study Patients with any conditions listed in special precautions, drug interactions, and contraindication of Spiriva in Austrian summary of product characteristics
Data sourced from ClinicalTrials.gov (NCT00615992). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.