Effect of Spiriva on the Activities of Daily Living Score Recommended in Austrian COPD Guidelines
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00615992
First received: January 24, 2008
Last updated: May 18, 2012
Last verified: May 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Pulmonary Disease, Chronic Obstructive |
Drug: Tiotropium |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort |
| Official Title: | Effect of Spiriva on the Activities of Daily Living Score Recommended in Austrian COPD Guidelines |
Resource links provided by NLM:
MedlinePlus related topics:
COPD (Chronic Obstructive Pulmonary Disease)
Drug Information available for:
Tiotropium bromide
U.S. FDA Resources
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- Activities of Daily Living Score After 3 to 4 Weeks Treatment With Spiriva [ Time Frame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days) ]The scores are final, not a difference in score. Rating scale scored from 0 (no restrictions in activities) to 4 (severe restrictions)
Secondary Outcome Measures:
- Dyspnea Score After 3 to 4 Weeks Treatment With Spiriva [ Time Frame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days) ]The scores are final, not a difference in score. Rating scale scored from 0 (no restrictions in activities) to 4 (severe restrictions)
- Global Assessment of Efficacy by Patient [ Time Frame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days) ]Rating scale ranging from very good (best value) to not satisfactory (worst value)
- Global Assessment of Tolerability by Patient [ Time Frame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days) ]Rating scale ranging from very good (best value) to not satisfactory (worst value)
- Global Assessment of Efficacy by Physician [ Time Frame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days) ]Rating scale ranging from very good (best value) to not satisfactory (worst value)
- Global Assessment of Tolerability by Physician [ Time Frame: Protocol-defined treatment period between initiation of therapy with Spiriva and the final visit (21 to 28 days) ]Rating scale ranging from very good (best value) to not satisfactory (worst value)
| Enrollment: | 754 |
| Study Start Date: | April 2007 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
primary care
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00615992
Show 74 Study Locations
Show 74 Study LocationsSponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
Additional Information:
No publications provided
| Responsible Party: | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT00615992 History of Changes |
| Other Study ID Numbers: | 205.398 |
| Study First Received: | January 24, 2008 |
| Results First Received: | June 30, 2009 |
| Last Updated: | May 18, 2012 |
| Health Authority: | Austria: Federal Office for Safety in Health Care |
Additional relevant MeSH terms:
|
Chronic Disease Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Disease Attributes Pathologic Processes Respiratory Tract Diseases Lung Diseases, Obstructive Tiotropium Parasympatholytics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Bronchodilator Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013